Lichen Planus, OralNCT03320460
Photobiomodulation in Oral Lichen Planus
A study testing Propionate clobetasol gel 0.05% and Photobiomodulation in people with Lichen Planus, Oral and Low-Level Light Therapy, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
The aim of this study was to compare the efficacy of PBM (660nm) and corticosteroid therapy with clobetasol propionate 0.05% in the treatment of OLP. This is a protocol for a randomized, controlled, double blind clinical trial. Fourty-four patients will be randomized in two experimental groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lichen Planus, Oral, Low-Level Light Therapy
- What is being tested?
- Propionate clobetasol gel 0.05% and Photobiomodulation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2018to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participants in this study will be male and female (aged over 18 years) diagnosed with symptomatic oral lichen planus, based on the clinical and histopathological criteria of the World Health Organization (WHO).
Who cannot join
- Patients with ongoing cancer; pregnant or breastfeeding women; patients with history of corticosteroids and nonsteroidal anti-inflammatory treatment in the last one months, patients with uncontrolled systemic disease; consumption of illicit drugs; use of medication associated with oral lichenoid reactions; amalgam restoration near to OLP lesions; epithelial dysplasia in the histopathological examination.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Scholl of Dentistry, University of São Paulo
São Paulo, São Paulo, 05508000
Camilla Barros Gallo, PhD, 1130917883, fernandarodrigues@uni9.pro.br
Maria F Rodrigues, PhD
About this study
Official title: Efficacy of Photobiomodulation for Oral Lichen Planus Treatment
The aim of this study was to compare the efficacy of PBM (660nm) and corticosteroid therapy with clobetasol propionate 0.05% in the treatment of OLP. This is a protocol for a randomized, controlled, double blind clinical trial. Fourty-four patients will be randomized in two experimental groups. Control group will be treated with clobetasol propionate 0.05% for 30 consecutive days and with placebo PBM twice a week. The experimental group will be treated with placebo gel for 30 consecutive days to mask the treatment and patients will receive PBM twice a week during 1 month (laser λ = 660±10 nm; power 100mW; radiant energy 177J/cm2; 5-s exposure time per point and 0.5J of energy per point. The primary variable (pain) and the secondary variables including clinical scores and functional scores as well as patient anxiety and depression (The Hospital Anxiety and Depression Scale-HADS), will be evaluated at the baseline, once a week during treatment and after 30 and 60 days of follow up. Evaluation of clinical resolution will be performed at the end of the treatment (30 days). Evaluation of recurrence will be performed after 30 and 60 days of follow up. Serum and salivary levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated at baseline and at the end of treatment (30 days). Quality of life will be evaluated by OHIP-14 questionnaire at baseline, at the end of treatment and after 30 and 60 days of follow up. The chi-square test, Student's t-test and ANOVA will be used and the level of significance of 5% will be considered (p < 0.05).
Read the detailed description
Oral lichen planus is an idiopathic chronic mucocutaneous disease with a ride range of clinical manifestations, including white reticular patches, erosive/ulcerative and atrophic lesions, both associated with intense symptomatology. CD4+ and CD8+ T lymphocytes cells play an important role in the pathogenesis of OLP and are responsible for the production of different cytokines, including IL-6, IL-10, IL-1β, INF-γ and TNF-α. Treatment is symptomatic and topical corticosteroids are commonly used as standard therapy. However, patients frequently present relapses after treatment's discontinuation, develop resistance to corticosteroids therapy as well as secondary candidiasis. Photobiomodulation (PBM) has shown to be a potential therapeutic tool to treat inflammatory disorders, including OLP. Some studies have demonstrated that PBM improves the clinical presentation of OLP (erosive/ulcerative or atrophic lesions to reticular lesions), reduces pain and recurrence. However, it remains controversy if PBM is more effective than corticosteroid in the treatment of OLP. The aim of this study is to evaluate the efficacy of PBM in the treatment of OLP in relation to the standard therapy with corticosteroids. This is a protocol for a randomized, controlled, doubled blind clinical trial, with two months of follow up.
Patients with symptomatic OLP and with histopathological diagnosis of OLP based on WHO criteria will be included in this study. Fourty-four patients will be randomized in two experimental groups. Control group will be treated with clobetasol propionate 0.05% gel for 30 consecutive days and the laser device will be positioned over the lesion but will be switched off to mask the treatment. The experimental group will be treated with placebo gel for 30 consecutive days to mask the treatment and patients will receive laser treatment twice a week during 1 month for PBM (laser λ = 660±10 nm; power 100mW; radiant energy; 177J/cm2; 5-s exposure time per point and 0.5J of energy per point). The primary variable (pain by VAS scale) and the secondary variables (clinical scores, functional scores and Patient anxiety and depression) will be evaluated at the baseline, once a week during treatment and after 30 and 60 days of follow up. Evaluation of clinical resolution will be performed at the end of the treatment (30 days). Evaluation of recurrence will be performed after 30 and 60 days of follow up. Serum and salivary levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated at baseline and at the end of treatment (30 days). Quality of life will be evaluated by OHIP-14 questionnaire at baseline, at the end of treatment and after 30 and 60 days of follow up. The findings will be computed and submitted to statistical analysis. Interval estimates will be used for the variables of interest to determine the prevision of the estimates and perform comparisons. If necessary, transformation methods or non-parametric tests will be applied. The chi-square test, Student's t-test and ANOVA will be used and the level of significance of 5% will be considered (p < 0.05).
- Conditions
- Lichen Planus, Oral, Low-Level Light Therapy
- Being tested
- Propionate clobetasol gel 0.05%, Photobiomodulation, Placebo gel, Placebo Photobiomodulation
- Keywords
- oral lichen planus; photobiomodulation; inflammation
- Medical subject headings
- Lichen Planus, Oral, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propionate clobetasol gel 0.05%Drug
Also called Clobetasol
Patients will be treated with Propionate clobetasol gel 0.05% for 30 consecutive days and with placebo laser twice a week. Patients will be instructed to apply the propionate clobetasol gel 0.05% in the entire lesion three times/days. To prevent oral candidiasis, patients will use micostatin solution (Nystatin oral suspension 100,000 USP/ml) once a day during 4 weeks.
PhotobiomodulationDevice
Also called Low level laser therapy
Patients will be treated with localized PBM with a diode laser with continuous wave (laser λ = 660 nm; power 100mW;radiant energy: 177J/cm2; 5-s exposure time per point and 0.5J of energy per point) applied directly to the surrounding oral mucosa and to the center of OLP, always by the same operator, twice a week for 4 weeks, totaling 8 session. The number of points will be variable according to the lesion size. The output power of the laser equipment will be evaluated using a power meter (Laser Check; MMOptics LTDA, São Paulo, Brazil) before treatment to confirm the effective mean power as well as the doses applied during the procedure.
Placebo gelOther
Also called inative gel
Placebo gel for 30 consecutive days to mask the treatment
Placebo PhotobiomodulationOther
Also called Laser off
Laser device will be positioned over the lesion but will be switched off to mask the treatment.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation | Experimental | Patients will be treated with localized PBM with a diode laser with continuous wave (laser λ =660 nm; power 100mW;radiant energy: 177J/cm2; 5-s exposure time per point and 0.5J of energy per point) applied directly to the surrounding oral mucosa and to the center of OLP, always by the same operator, twice a week for 4 weeks, totaling 8 session. The number of points will be variable according to the lesion size. The output power of the laser equipment will be evaluated using a power meter (Laser Check; MMOptics LTDA, São Paulo, Brazil) before treatment to confirm the effective mean power as well as the doses applied during the procedure. Receives: Device: Photobiomodulation; Other: Placebo gel |
| Propionate clobetasol gel 0.05% | Active comparator | Patients will be treated with Propionate clobetasol gel 0.05% for 30 consecutive days. Laser device will be positioned over the lesion but will be switched off to mask the treatment. Patients will be instructed to apply the propionate clobetasol gel 0.05% in the entire lesion three times/days. To prevent oral candidiasis, patients will use micostatin solution (Nystatin oral suspension 100,000 USP/ml) once a day during 4 weeks. Receives: Drug: Propionate clobetasol gel 0.05%; Other: Placebo Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Pain of OLP
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
Measured: Participants will be evaluated at baseline (Day 0)
Assessment of Pain of OLP
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
Measured: Participants will be evaluated after 1 week of treatment (Day 7)
Assessment of Pain of OLP
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
Measured: Participants will be evaluated after 2 weeks of treatment (Day 14)
Assessment of Pain of OLP
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
Measured: Participants will be evaluated after 3 weeks of treatment (Day 21)
Assessment of Pain of OLP
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
Measured: Participants will be evaluated after 4 weeks of treatment (Day 30)
Assessment of Pain of OLP
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
Measured: 30 days after the discontinuation of treatment (follow-up period)
Assessment of Pain of OLP
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
Measured: 60 days after the discontinuation of treatment (follow-up period)
Secondary outcomes (32)
Assessment of clinical presentation of OLP
Clinical data will be evaluated by scores according to Thongprasom et al
Measured: Participants will be evaluated at baseline (Day 0)
Assessment of clinical presentation of OLP
Clinical data will be evaluated by scores according to Thongprasom et al
Measured: Participants will be evaluated after 1 week of treatment (Day 7)
Assessment of clinical presentation of OLP
Clinical data will be evaluated by scores according to Thongprasom et al
Measured: Participants will be evaluated after 2 weeks of treatment (Day 14)
Assessment of clinical presentation of OLP
Clinical data will be evaluated scores according to Thongprasom et al
Measured: Participants will be evaluated after 3 weeks of treatment (Day 21)
Assessment of clinical presentation of OLP
Clinical data will be evaluated by scores according to Thongprasom et al
Measured: Participants will be evaluated after 4 weeks of treatment (Day 30)
Assessment of clinical presentation of OLP
Clinical data will be evaluated by scores according to Thongprasom et al
Measured: 30 days after the discontinuation of treatment (follow-up period)
Assessment of clinical presentation of OLP
Clinical data will be evaluated by scores according to Thongprasom et al
Measured: 60 days after the discontinuation of treatment (follow-up period)
Function
The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function).
Measured: Participants will be evaluated at baseline (Day 0)
Function
The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function).
Measured: Participants will be evaluated after 1 week of treatment (Day 7)
Function
The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function).
Measured: Participants will be evaluated after 2 weeks of treatment (Day 14)
Function
The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function).
Measured: Participants will be evaluated after 3 weeks of treatment (Day 21)
Function
The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function).
Measured: Participants will be evaluated after 4 weeks of treatment (Day 30)
Function
The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function).
Measured: 30 days after the discontinuation of treatment (follow-up period)
Function
The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function).
Measured: 60 days after the discontinuation of treatment (follow-up period)
Clinical Resolution
The clinical resolution will be evaluated at the end of treatment (day 30) according to Corozzo et al. (1999). Complete resolution will be considered when patients present absence of symptoms and remission of atrophic/erosive lesions regardless the presence of any persisting hyperkeratotic lesions. Partial resolution will be considered when a decrease but not the complete remission of atrophic/erosive areas and symptoms were observed. No response to treatment will be considered when OLP lesions present the same clinical or worse presentation in relation to the baseline condition.
Measured: Participants will be evaluated after 4 weeks of treatment (Day 30)
Recurrence rate
No recurrence will be considered when the patient presents the same clinical aspect of lesion at the end of treatment and recurrence, when the patient present new atrophic/erosive lesion at the same site during the follow-up period.
Measured: The recurrence rate will be evaluated 30 days after the discontinuation of treatment (follow-up period)
Recurrence rate
No recurrence will be considered when the patient presents the same clinical aspect of lesion at the end of treatment and recurrence, when the patient present new atrophic/erosive lesion at the same site during the follow-up period.
Measured: The recurrence rate will be evaluated 60 days after the discontinuation of treatment (follow-up period)
Salivary levels of IL-1β, IL-6, IL-8, IL-10 and TNFα
The samples will be centrifuged and stored at -80°C. Salivary levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated by Enzyme Linked Immune Sorbent Assay (ELISA), according to manufacturer's instructions.
Measured: Baseline (day 0)
Salivary levels of IL-1β, IL-6, IL-8, IL-10 and TNFα
The samples will be centrifuged and stored at -80°C. Salivary levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated by Enzyme Linked Immune Sorbent Assay (ELISA), according to manufacturer's instructions.
Measured: After 4 weeks of treatment (Day 30)
Serum levels of IL-1β, IL-6, IL-8, IL-10 and TNFα
Peripheral blood will be centrifuged at 400xg for 10 min at 4°C. Serum will be collected and stored at -80°C. Serum levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated by Enzyme Linked Immune Sorbent Assay (ELISA), according to manufacturer's instructions.
Measured: Baseline (Day 0)
Serum levels of IL-1β, IL-6, IL-8, IL-10 and TNFα
Peripheral blood will be centrifuged at 400xg for 10 min at 4°C. Serum will be collected and stored at -80°C. Serum levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated by Enzyme Linked Immune Sorbent Assay (ELISA), according to manufacturer's instructions.
Measured: After 4 weeks of treatment (Day 30)
Assessment of Quality of life in OLP patients
Patient quality of life will be measured by means of the Oral Health Impact Profile (OHIP 14)
Measured: Baseline (Day 0)
Assessment of Quality of life in OLP patients
Patient quality of life will be measured by means of the Oral Health Impact Profile (OHIP 14)
Measured: After 4 weeks of treatment (Day 30)
Assessment of Quality of life in OLP patients
Patient quality of life will be measured by means of the Oral Health Impact Profile (OHIP 14)
Measured: 30 days after the discontinuation of treatment (follow-up period)
Assessment of Quality of lifein OLP patients
Patient quality of life will be measured by means of the Oral Health Impact Profile (OHIP 14)
Measured: 60 days after the discontinuation of treatment (follow-up period)
Anxiety and Depression
Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS)
Measured: Baseline (Day 0)
Anxiety and Depression
Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS)
Measured: Participants will be evaluated after 1 week of treatment (Day 7)
Anxiety and Depression
Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS)
Measured: Participants will be evaluated after 2 weeks of treatment (Day 14)
Anxiety and Depression
Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS)
Measured: Participants will be evaluated after 3 weeks of treatment (Day 21)
Anxiety and Depression
Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS)
Measured: Participants will be evaluated after 4 weeks of treatment (Day 30)
Anxiety and Depression
Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS)
Measured: 30 days after the discontinuation of treatment (follow-up period)
Anxiety and Depression
Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS)
Measured: 60 days after the discontinuation of treatment (follow-up period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start1 Nov 2018
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Lichen Planus, OralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control group Experimental Group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Fernanda Setúbal Destro Rodrigues, University of Nove de Julho
- Investigators
- Maria Fernanda SD Rodrigues, PhD, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320460
- Sponsor's protocol ID
- 2.375.410
- Status last verified
- Dec 2018
- First submitted
- 17 Oct 2017
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akram Z, Abduljabbar T, Vohra F, Javed F. Efficacy of low-level laser therapy compared to steroid therapy in the treatment of oral lichen planus: A systematic review. J Oral Pathol Med. 2018 Jan;47(1):11-17. doi: 10.1111/jop.12619. Epub 2017 Aug 21.
PubMed 28766756Dillenburg CS, Martins MA, Munerato MC, Marques MM, Carrard VC, Sant'Ana Filho M, Castilho RM, Martins MD. Efficacy of laser phototherapy in comparison to topical clobetasol for the treatment of oral lichen planus: a randomized controlled trial. J Biomed Opt. 2014 Jun;19(6):068002. doi: 10.1117/1.JBO.19.6.068002.
PubMed 24887747Sulewska M, Duraj E, Sobaniec S, Graczyk A, Milewski R, Wroblewska M, Pietruski J, Pietruska M. A clinical evaluation of the efficacy of photodynamic therapy in the treatment of erosive oral lichen planus: A case series. Photodiagnosis Photodyn Ther. 2017 Jun;18:12-19. doi: 10.1016/j.pdpdt.2017.01.178. Epub 2017 Jan 22.
PubMed 28119140DeLand MM, Weiss RA, McDaniel DH, Geronemus RG. Treatment of radiation-induced dermatitis with light-emitting diode (LED) photomodulation. Lasers Surg Med. 2007 Feb;39(2):164-8. doi: 10.1002/lsm.20455.
PubMed 17311276Nogueira PA, Carneiro S, Ramos-e-Silva M. Oral lichen planus: an update on its pathogenesis. Int J Dermatol. 2015 Sep;54(9):1005-10. doi: 10.1111/ijd.12918. Epub 2015 Jul 3.
PubMed 26147778Alrashdan MS, Cirillo N, McCullough M. Oral lichen planus: a literature review and update. Arch Dermatol Res. 2016 Oct;308(8):539-51. doi: 10.1007/s00403-016-1667-2. Epub 2016 Jun 27.
PubMed 27349424Thongprasom K, Luangjarmekorn L, Sererat T, Taweesap W. Relative efficacy of fluocinolone acetonide compared with triamcinolone acetonide in treatment of oral lichen planus. J Oral Pathol Med. 1992 Nov;21(10):456-8. doi: 10.1111/j.1600-0714.1992.tb00974.x.
PubMed 1460584Lilleby K, Garcia P, Gooley T, McDonnnell P, Taber R, Holmberg L, Maloney DG, Press OW, Bensinger W. A prospective, randomized study of cryotherapy during administration of high-dose melphalan to decrease the severity and duration of oral mucositis in patients with multiple myeloma undergoing autologous peripheral blood stem cell transplantation. Bone Marrow Transplant. 2006 Jun;37(11):1031-5. doi: 10.1038/sj.bmt.1705384.
PubMed 16633359Carrozzo M, Gandolfo S, Lodi G, Carbone M, Garzino-Demo P, Carbonero C, Porter SR, Scully C. Oral lichen planus in patients infected or noninfected with hepatitis C virus: the role of autoimmunity. J Oral Pathol Med. 1999 Jan;28(1):16-9. doi: 10.1111/j.1600-0714.1999.tb01988.x.
PubMed 9890452Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.
PubMed 9332805Sobral SS, da Silva Brandao EH, de Barros Gallo C, Molon A, Sobral APT, de Fatima Teixeira da Silva D, Motta LJ, Dos Santos Franco AL, Rodrigues MFSD. Analysis of the psychopathological profile, quality of life, and cost-effectiveness of oral lichen planus patients treated with photobiomodulation. Clin Oral Investig. 2022 Jan;26(1):719-728. doi: 10.1007/s00784-021-04050-z. Epub 2021 Jul 12.
PubMed 34251533Ferri EP, Gallo CB, Abboud CS, Yanaguizawa WH, Horliana ACRT, Silva DFTD, Pavani C, Bussadori SK, Nunes FD, Mesquita-Ferrari RA, Fernandes KPS, Rodrigues MFSD. Efficacy of photobiomodulation on oral lichen planus: a protocol study for a double-blind, randomised controlled clinical trial. BMJ Open. 2018 Oct 8;8(10):e024083. doi: 10.1136/bmjopen-2018-024083.
PubMed 30297352
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Photobiomodulation for Oral Lichen Planus Treatment
- ClinicalTrials.gov ID
- NCT03320460
- Acronym / sponsor ID
- 2.375.410
- Conditions
- Lichen Planus, Oral, Low-Level Light Therapy
- Keywords
- oral lichen planus; photobiomodulation; inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 25 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to compare the efficacy of PBM (660nm) and corticosteroid therapy with clobetasol propionate 0.05% in the treatment of OLP. This is a protocol for a randomized, controlled, double blind clinical trial. Fourty-four patients will be randomized in two experimental groups. Control group will be treated with clobetasol propionate 0.05% for 30 consecutive days and with placebo PBM twice a week. The experimental group will be treated with placebo gel for 30 consecutive days to mask the treatment and patients will receive PBM twice a week during 1 month (laser λ = 660±10 nm; power 100mW; radiant energy 177J/cm2; 5-s exposure time per point and 0.5J of energy per point. The primary variable (pain) and the secondary variables including clinical scores and functional scores as well as patient anxiety and depression (The Hospital Anxiety and Depression Scale-HADS), will be evaluated at the baseline, once a week during treatment and after 30 and 60 days of follow up. Evaluation of clinical resolution will be performed at the end of the treatment (30 days). Evaluation of recurrence will be performed after 30 and 60 days of follow up. Serum and salivary levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated at baseline and at the end of treatment (30 days). Quality of life will be evaluated by OHIP-14 questionnaire at baseline, at the end of treatment and after 30 and 60 days of follow up. The chi-square test, Student's t-test and ANOVA will be used and the level of significance of 5% will be considered (p < 0.05).
Detailed description
Oral lichen planus is an idiopathic chronic mucocutaneous disease with a ride range of clinical manifestations, including white reticular patches, erosive/ulcerative and atrophic lesions, both associated with intense symptomatology. CD4+ and CD8+ T lymphocytes cells play an important role in the pathogenesis of OLP and are responsible for the production of different cytokines, including IL-6, IL-10, IL-1β, INF-γ and TNF-α. Treatment is symptomatic and topical corticosteroids are commonly used as standard therapy. However, patients frequently present relapses after treatment's discontinuation, develop resistance to corticosteroids therapy as well as secondary candidiasis. Photobiomodulation (PBM) has shown to be a potential therapeutic tool to treat inflammatory disorders, including OLP. Some studies have demonstrated that PBM improves the clinical presentation of OLP (erosive/ulcerative or atrophic lesions to reticular lesions), reduces pain and recurrence. However, it remains controversy if PBM is more effective than corticosteroid in the treatment of OLP. The aim of this study is to evaluate the efficacy of PBM in the treatment of OLP in relation to the standard therapy with corticosteroids. This is a protocol for a randomized, controlled, doubled blind clinical trial, with two months of follow up.
Patients with symptomatic OLP and with histopathological diagnosis of OLP based on WHO criteria will be included in this study. Fourty-four patients will be randomized in two experimental groups. Control group will be treated with clobetasol propionate 0.05% gel for 30 consecutive days and the laser device will be positioned over the lesion but will be switched off to mask the treatment. The experimental group will be treated with placebo gel for 30 consecutive days to mask the treatment and patients will receive laser treatment twice a week during 1 month for PBM (laser λ = 660±10 nm; power 100mW; radiant energy; 177J/cm2; 5-s exposure time per point and 0.5J of energy per point). The primary variable (pain by VAS scale) and the secondary variables (clinical scores, functional scores and Patient anxiety and depression) will be evaluated at the baseline, once a week during treatment and after 30 and 60 days of follow up. Evaluation of clinical resolution will be performed at the end of the treatment (30 days). Evaluation of recurrence will be performed after 30 and 60 days of follow up. Serum and salivary levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated at baseline and at the end of treatment (30 days). Quality of life will be evaluated by OHIP-14 questionnaire at baseline, at the end of treatment and after 30 and 60 days of follow up. The findings will be computed and submitted to statistical analysis. Interval estimates will be used for the variables of interest to determine the prevision of the estimates and perform comparisons. If necessary, transformation methods or non-parametric tests will be applied. The chi-square test, Student's t-test and ANOVA will be used and the level of significance of 5% will be considered (p < 0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Control group Experimental Group
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation | Experimental | Device: Photobiomodulation, Other: Placebo gelPatients will be treated with localized PBM with a diode laser with continuous wave (laser λ =660 nm; power 100mW;radiant energy: 177J/cm2; 5-s exposure time per point and 0.5J of energy per point) applied directly to the surrounding oral mucosa and to the center of OLP, always by the same operator, twice a week for 4 weeks, totaling 8 session. The number of points will be variable according to the lesion size. The output power of the laser equipment will be evaluated using a power meter (Laser Check; MMOptics LTDA, São Paulo, Brazil) before treatment to confirm the effective mean power as well as the doses applied during the procedure. |
| Propionate clobetasol gel 0.05% | Active comparator | Drug: Propionate clobetasol gel 0.05%, Other: Placebo PhotobiomodulationPatients will be treated with Propionate clobetasol gel 0.05% for 30 consecutive days. Laser device will be positioned over the lesion but will be switched off to mask the treatment. Patients will be instructed to apply the propionate clobetasol gel 0.05% in the entire lesion three times/days. To prevent oral candidiasis, patients will use micostatin solution (Nystatin oral suspension 100,000 USP/ml) once a day during 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The participants in this study will be male and female (aged over 18 years) diagnosed with symptomatic oral lichen planus, based on the clinical and histopathological criteria of the World Health Organization (WHO).
Key exclusion criteria (1 listed)
- Patients with ongoing cancer; pregnant or breastfeeding women; patients with history of corticosteroids and nonsteroidal anti-inflammatory treatment in the last one months, patients with uncontrolled systemic disease; consumption of illicit drugs; use of medication associated with oral lichenoid reactions; amalgam restoration near to OLP lesions; epithelial dysplasia in the histopathological examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propionate clobetasol gel 0.05%Also: ClobetasolPatients will be treated with Propionate clobetasol gel 0.05% for 30 consecutive days and with placebo laser twice a week. Patients will be instructed to apply the propionate clobetasol gel 0.05% in the entire lesion three times/days. To prevent oral candidiasis, patients will use micostatin solution (Nystatin oral suspension 100,000 USP/ml) once a day during 4 weeks. | Drug | Propionate clobetasol gel 0.05% |
| PhotobiomodulationAlso: Low level laser therapyPatients will be treated with localized PBM with a diode laser with continuous wave (laser λ = 660 nm; power 100mW;radiant energy: 177J/cm2; 5-s exposure time per point and 0.5J of energy per point) applied directly to the surrounding oral mucosa and to the center of OLP, always by the same operator, twice a week for 4 weeks, totaling 8 session. The number of points will be variable according to the lesion size. The output power of the laser equipment will be evaluated using a power meter (Laser Check; MMOptics LTDA, São Paulo, Brazil) before treatment to confirm the effective mean power as well as the doses applied during the procedure. | Device | Photobiomodulation |
| Placebo gelAlso: inative gelPlacebo gel for 30 consecutive days to mask the treatment | Other | Photobiomodulation |
| Placebo PhotobiomodulationAlso: Laser offLaser device will be positioned over the lesion but will be switched off to mask the treatment. | Other | Propionate clobetasol gel 0.05% |
Primary outcome
Assessment of Pain of OLP
Time frame: Participants will be evaluated at baseline (Day 0)
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
Assessment of Pain of OLP
Time frame: Participants will be evaluated after 1 week of treatment (Day 7)
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
Assessment of Pain of OLP
Time frame: Participants will be evaluated after 2 weeks of treatment (Day 14)
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
Assessment of Pain of OLP
Time frame: Participants will be evaluated after 3 weeks of treatment (Day 21)
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
Assessment of Pain of OLP
Time frame: Participants will be evaluated after 4 weeks of treatment (Day 30)
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
Assessment of Pain of OLP
Time frame: 30 days after the discontinuation of treatment (follow-up period)
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
Assessment of Pain of OLP
Time frame: 60 days after the discontinuation of treatment (follow-up period)
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
32 secondary outcomes
Assessment of clinical presentation of OLP
Time frame: Participants will be evaluated at baseline (Day 0)
Assessment of clinical presentation of OLP
Time frame: Participants will be evaluated after 1 week of treatment (Day 7)
Assessment of clinical presentation of OLP
Time frame: Participants will be evaluated after 2 weeks of treatment (Day 14)
Assessment of clinical presentation of OLP
Time frame: Participants will be evaluated after 3 weeks of treatment (Day 21)
Assessment of clinical presentation of OLP
Time frame: Participants will be evaluated after 4 weeks of treatment (Day 30)
Assessment of clinical presentation of OLP
Time frame: 30 days after the discontinuation of treatment (follow-up period)
Assessment of clinical presentation of OLP
Time frame: 60 days after the discontinuation of treatment (follow-up period)
Function
Time frame: Participants will be evaluated at baseline (Day 0)
Function
Time frame: Participants will be evaluated after 1 week of treatment (Day 7)
Function
Time frame: Participants will be evaluated after 2 weeks of treatment (Day 14)
Function
Time frame: Participants will be evaluated after 3 weeks of treatment (Day 21)
Function
Time frame: Participants will be evaluated after 4 weeks of treatment (Day 30)
Function
Time frame: 30 days after the discontinuation of treatment (follow-up period)
Function
Time frame: 60 days after the discontinuation of treatment (follow-up period)
Clinical Resolution
Time frame: Participants will be evaluated after 4 weeks of treatment (Day 30)
Recurrence rate
Time frame: The recurrence rate will be evaluated 30 days after the discontinuation of treatment (follow-up period)
Recurrence rate
Time frame: The recurrence rate will be evaluated 60 days after the discontinuation of treatment (follow-up period)
Salivary levels of IL-1β, IL-6, IL-8, IL-10 and TNFα
Time frame: Baseline (day 0)
Salivary levels of IL-1β, IL-6, IL-8, IL-10 and TNFα
Time frame: After 4 weeks of treatment (Day 30)
Serum levels of IL-1β, IL-6, IL-8, IL-10 and TNFα
Time frame: Baseline (Day 0)
Serum levels of IL-1β, IL-6, IL-8, IL-10 and TNFα
Time frame: After 4 weeks of treatment (Day 30)
Assessment of Quality of life in OLP patients
Time frame: Baseline (Day 0)
Assessment of Quality of life in OLP patients
Time frame: After 4 weeks of treatment (Day 30)
Assessment of Quality of life in OLP patients
Time frame: 30 days after the discontinuation of treatment (follow-up period)
Assessment of Quality of lifein OLP patients
Time frame: 60 days after the discontinuation of treatment (follow-up period)
Anxiety and Depression
Time frame: Baseline (Day 0)
Anxiety and Depression
Time frame: Participants will be evaluated after 1 week of treatment (Day 7)
Anxiety and Depression
Time frame: Participants will be evaluated after 2 weeks of treatment (Day 14)
Anxiety and Depression
Time frame: Participants will be evaluated after 3 weeks of treatment (Day 21)
Anxiety and Depression
Time frame: Participants will be evaluated after 4 weeks of treatment (Day 30)
Anxiety and Depression
Time frame: 30 days after the discontinuation of treatment (follow-up period)
Anxiety and Depression
Time frame: 60 days after the discontinuation of treatment (follow-up period)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
- Background: PubMed 28766756Akram Z, Abduljabbar T, Vohra F, Javed F. Efficacy of low-level laser therapy compared to steroid therapy in the treatment of oral lichen planus: A systematic review. J Oral Pathol Med. 2018 Jan;47(1):11-17. doi: 10.1111/jop.12619. Epub 2017 Aug 21.
- Background: PubMed 24887747Dillenburg CS, Martins MA, Munerato MC, Marques MM, Carrard VC, Sant'Ana Filho M, Castilho RM, Martins MD. Efficacy of laser phototherapy in comparison to topical clobetasol for the treatment of oral lichen planus: a randomized controlled trial. J Biomed Opt. 2014 Jun;19(6):068002. doi: 10.1117/1.JBO.19.6.068002.
- Background: PubMed 28119140Sulewska M, Duraj E, Sobaniec S, Graczyk A, Milewski R, Wroblewska M, Pietruski J, Pietruska M. A clinical evaluation of the efficacy of photodynamic therapy in the treatment of erosive oral lichen planus: A case series. Photodiagnosis Photodyn Ther. 2017 Jun;18:12-19. doi: 10.1016/j.pdpdt.2017.01.178. Epub 2017 Jan 22.
- Background: PubMed 17311276DeLand MM, Weiss RA, McDaniel DH, Geronemus RG. Treatment of radiation-induced dermatitis with light-emitting diode (LED) photomodulation. Lasers Surg Med. 2007 Feb;39(2):164-8. doi: 10.1002/lsm.20455.
- Background: PubMed 26147778Nogueira PA, Carneiro S, Ramos-e-Silva M. Oral lichen planus: an update on its pathogenesis. Int J Dermatol. 2015 Sep;54(9):1005-10. doi: 10.1111/ijd.12918. Epub 2015 Jul 3.
- Background: PubMed 27349424Alrashdan MS, Cirillo N, McCullough M. Oral lichen planus: a literature review and update. Arch Dermatol Res. 2016 Oct;308(8):539-51. doi: 10.1007/s00403-016-1667-2. Epub 2016 Jun 27.
- Background: PubMed 1460584Thongprasom K, Luangjarmekorn L, Sererat T, Taweesap W. Relative efficacy of fluocinolone acetonide compared with triamcinolone acetonide in treatment of oral lichen planus. J Oral Pathol Med. 1992 Nov;21(10):456-8. doi: 10.1111/j.1600-0714.1992.tb00974.x.
- Background: PubMed 16633359Lilleby K, Garcia P, Gooley T, McDonnnell P, Taber R, Holmberg L, Maloney DG, Press OW, Bensinger W. A prospective, randomized study of cryotherapy during administration of high-dose melphalan to decrease the severity and duration of oral mucositis in patients with multiple myeloma undergoing autologous peripheral blood stem cell transplantation. Bone Marrow Transplant. 2006 Jun;37(11):1031-5. doi: 10.1038/sj.bmt.1705384.
- Background: PubMed 9890452Carrozzo M, Gandolfo S, Lodi G, Carbone M, Garzino-Demo P, Carbonero C, Porter SR, Scully C. Oral lichen planus in patients infected or noninfected with hepatitis C virus: the role of autoimmunity. J Oral Pathol Med. 1999 Jan;28(1):16-9. doi: 10.1111/j.1600-0714.1999.tb01988.x.
- Background: PubMed 9332805Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.
- Derived from this study: PubMed 34251533Sobral SS, da Silva Brandao EH, de Barros Gallo C, Molon A, Sobral APT, de Fatima Teixeira da Silva D, Motta LJ, Dos Santos Franco AL, Rodrigues MFSD. Analysis of the psychopathological profile, quality of life, and cost-effectiveness of oral lichen planus patients treated with photobiomodulation. Clin Oral Investig. 2022 Jan;26(1):719-728. doi: 10.1007/s00784-021-04050-z. Epub 2021 Jul 12.
- Derived from this study: PubMed 30297352Ferri EP, Gallo CB, Abboud CS, Yanaguizawa WH, Horliana ACRT, Silva DFTD, Pavani C, Bussadori SK, Nunes FD, Mesquita-Ferrari RA, Fernandes KPS, Rodrigues MFSD. Efficacy of photobiomodulation on oral lichen planus: a protocol study for a double-blind, randomised controlled clinical trial. BMJ Open. 2018 Oct 8;8(10):e024083. doi: 10.1136/bmjopen-2018-024083.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Fernanda SD Rodrigues, PhD principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propionate clobetasol gel 0.05% and Photobiomodulation in people with Lichen Planus, Oral and Low-Level Light Therapy, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Paula C Silva, Bachelor (+ 55 11 3385-9197, aninha@uninove.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Pain of OLP (time frame: Participants will be evaluated at baseline (Day 0)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03320460, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2018.