Oral Lichen PlanusNCT05127083
Oral Lichen Planus Treatment
A study testing Patients will be treated with localized PBM with a diode laser in people with Oral Lichen Planus, run by Universidad de Murcia at 1 site in Spain.
Trial summary
Oral lichen planus (OLP) is a chronic inflammatory and immune-mediated disease affecting the oral mucosa. OLP presents with asymptomatic, lacelike white stripes and/or symptomatic red, ulcerated mucous membranes. Eating, drinking and oral hygiene procedures may be painful resulting in reduced quality of life (QOL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Patients will be treated with localized PBM with a diode laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 4 Jun 2018to 18 Oct 2021
- 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 patients with clinical or histopathological diagnosis of bilateral atrophic or erosive OLP (symptomatic OLP) who signed the written consent form were recruited.
Who cannot join
- Patients with drug-induced or contact lichenoid reactions, patients receiving any treatment for OLP in 2 months prior to the study, pregnant or lactating women, patients with uncontrolled systemic disease, and patients with photosensitivity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Lichen Planus Photodynamic Treatment
Oral lichen planus (OLP) is a chronic inflammatory and immune-mediated disease affecting the oral mucosa. OLP presents with asymptomatic, lacelike white stripes and/or symptomatic red, ulcerated mucous membranes. Eating, drinking and oral hygiene procedures may be painful resulting in reduced quality of life (QOL). Photodynamic therapy (PDT) is a new suggestion for OLP treatment PDT is a successful treatment mo- dality for premalignant and malignant diseases of head and neck,gastrointestinal tract, lung, and skin
In this study, the effect of photodynamic therapy with topical corticosteroid in oral lichen planus patients was compared
Read the detailed description
In this study, the efficacy of toluidine blue-mediated photodynamic therapy and topical triamcinolone acetonide 0.2% on decreasing pain and size of OLP lesions was compared.
This randomized, clinical trial compared the therapeutic effect of photodynamic therapy on symptomatic OLP (atrophic/ erosive/ulcerative forms) with triamcinolone acetonide 0.2%. The protocol of the clinical trial, which was conducted according to the ethical principles of Helsinki Group I toluidine blue-mediated photodynamic therapy Group II photodynamic therapy GroupIII laser sham + triamcinolone acetonide 0.2%
- Conditions
- Oral Lichen Planus
- Being tested
- Patients will be treated with localized PBM with a diode laser
- Keywords
- pain, oral lichen planus ; photodynamic therapy
- Medical subject headings
- Lichen Planus, Oral, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients will be treated with localized PBM with a diode laserRadiation
Toluidine blue was applied on the lesions.The tissue were irradiated with a 660-nm diode laser InGaAlP
| Study group | Role | What they receive |
|---|---|---|
| toluidine blue-mediated photodynamic therapy | Experimental | The number of points will be variable according to the lesion size. Patients will be treated with localized PBM with a diode laser with continuous wave +toluidine blue Receives: Radiation: Patients will be treated with localized PBM with a diode laser |
| photodynamic therapy + gel | Active comparator | The number of points will be variable according to the lesion size.atients will be treated with localized PBM with a diode laser with continuous wave Receives: Radiation: Patients will be treated with localized PBM with a diode laser |
| acetonide triamcinolone 0.2%+sham | Sham comparator | Patients will be treated with acetonide triamcinolone 0.2% 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 gel in the entire lesion three times/days.The number of points will be variable according to the lesion size. Receives: Radiation: Patients will be treated with localized PBM with a diode laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change 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) ; day 7: day 14 day and 28 day
Change Thongprasom sign scoring
a score of 0 for normal healthy mucosa, 1 for lesions with only white striae, 2 for mixed keratotic and atrophic or erythematous lesions < 1 cm2 in size, 3 for keratotic and atrophic or erythematous lesions more than 1 cm2 in size, 4 for erosive/ulcerative lesions smaller than 1 cm2 , and 5 for erosive/ulcerative lesions larger than 1 cm2
Measured: Participants will be evaluated at baseline (Day 0) ; day 7: day 14 day and 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start4 Jun 2018
- Primary completion3 Oct 2020
- Study completion18 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Oral Lichen PlanusStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pia Lopez Jornet, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127083
- Sponsor's protocol ID
- 2227/2018
- Status last verified
- Nov 2021
- First submitted
- 18 Oct 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Lavaee F, Shadmanpour M. Comparison of the effect of photodynamic therapy and topical corticosteroid on oral lichen planus lesions. Oral Dis. 2019 Nov;25(8):1954-1963. doi: 10.1111/odi.13188. Epub 2019 Oct 2.
PubMed 31478283Hoseinpour Jajarm H, Asadi R, Bardideh E, Shafaee H, Khazaei Y, Emadzadeh M. The effects of photodynamic and low-level laser therapy for treatment of oral lichen planus-A systematic review and meta-analysis. Photodiagnosis Photodyn Ther. 2018 Sep;23:254-260. doi: 10.1016/j.pdpdt.2018.07.001. Epub 2018 Jul 10.
PubMed 30006319Mostafa D, Moussa E, Alnouaem M. Evaluation of photodynamic therapy in treatment of oral erosive lichen planus in comparison with topically applied corticosteroids. Photodiagnosis Photodyn Ther. 2017 Sep;19:56-66. doi: 10.1016/j.pdpdt.2017.04.014. Epub 2017 Apr 25.
PubMed 28450262Rakesh N, Clint JB, Reddy SS, Nagi R, Chauhan P, Sharma S, Sharma P, Kaur A, Shetty B, Ashwini S, Pavan Kumar T, Vidya GS. Clinical evaluation of photodynamic therapy for the treatment of refractory oral Lichen planus - A case series. Photodiagnosis Photodyn Ther. 2018 Dec;24:280-285. doi: 10.1016/j.pdpdt.2018.09.011. Epub 2018 Sep 24.
PubMed 30261326Salinas-Gilabert C, Gomez Garcia F, Galera Molero F, Pons-Fuster E, Vander Beken S, Lopez Jornet P. Photodynamic Therapy, Photobiomodulation and Acetonide Triamcinolone 0.1% in the Treatment of Oral Lichen Planus: A Randomized Clinical Trial. Pharmaceutics. 2022 Dec 22;15(1):30. doi: 10.3390/pharmaceutics15010030.
PubMed 36678659
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Lichen Planus Photodynamic Treatment
- ClinicalTrials.gov ID
- NCT05127083
- Acronym / sponsor ID
- 2227/2018
- Conditions
- Oral Lichen Planus
- Keywords
- pain, oral lichen planus ; photodynamic therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 3 Oct 2020 (actual)
- Study completion
- 18 Oct 2021 (actual)
- First posted
- 19 Nov 2021 (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.
Oral lichen planus (OLP) is a chronic inflammatory and immune-mediated disease affecting the oral mucosa. OLP presents with asymptomatic, lacelike white stripes and/or symptomatic red, ulcerated mucous membranes. Eating, drinking and oral hygiene procedures may be painful resulting in reduced quality of life (QOL). Photodynamic therapy (PDT) is a new suggestion for OLP treatment PDT is a successful treatment mo- dality for premalignant and malignant diseases of head and neck,gastrointestinal tract, lung, and skin
In this study, the effect of photodynamic therapy with topical corticosteroid in oral lichen planus patients was compared
Detailed description
In this study, the efficacy of toluidine blue-mediated photodynamic therapy and topical triamcinolone acetonide 0.2% on decreasing pain and size of OLP lesions was compared.
This randomized, clinical trial compared the therapeutic effect of photodynamic therapy on symptomatic OLP (atrophic/ erosive/ulcerative forms) with triamcinolone acetonide 0.2%. The protocol of the clinical trial, which was conducted according to the ethical principles of Helsinki Group I toluidine blue-mediated photodynamic therapy Group II photodynamic therapy GroupIII laser sham + triamcinolone acetonide 0.2%
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| toluidine blue-mediated photodynamic therapy | Experimental | Radiation: Patients will be treated with localized PBM with a diode laserThe number of points will be variable according to the lesion size. Patients will be treated with localized PBM with a diode laser with continuous wave +toluidine blue |
| photodynamic therapy + gel | Active comparator | Radiation: Patients will be treated with localized PBM with a diode laserThe number of points will be variable according to the lesion size.atients will be treated with localized PBM with a diode laser with continuous wave |
| acetonide triamcinolone 0.2%+sham | Sham comparator | Radiation: Patients will be treated with localized PBM with a diode laserPatients will be treated with acetonide triamcinolone 0.2% 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 gel in the entire lesion three times/days.The number of points will be variable according to the lesion size. |
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 patients with clinical or histopathological diagnosis of bilateral atrophic or erosive OLP (symptomatic OLP) who signed the written consent form were recruited.
Key exclusion criteria (1 listed)
- Patients with drug-induced or contact lichenoid reactions, patients receiving any treatment for OLP in 2 months prior to the study, pregnant or lactating women, patients with uncontrolled systemic disease, and patients with photosensitivity
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 |
|---|---|---|
| Patients will be treated with localized PBM with a diode laserToluidine blue was applied on the lesions.The tissue were irradiated with a 660-nm diode laser InGaAlP | Radiation | acetonide triamcinolone 0.2%+sham, photodynamic therapy + gel, toluidine blue-mediated photodynamic therapy |
Primary outcome
Change Assessment of Pain of OLP
Time frame: Participants will be evaluated at baseline (Day 0) ; day 7: day 14 day and 28 day
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.
Change Thongprasom sign scoring
Time frame: Participants will be evaluated at baseline (Day 0) ; day 7: day 14 day and 28 day
a score of 0 for normal healthy mucosa, 1 for lesions with only white striae, 2 for mixed keratotic and atrophic or erythematous lesions < 1 cm2 in size, 3 for keratotic and atrophic or erythematous lesions more than 1 cm2 in size, 4 for erosive/ulcerative lesions smaller than 1 cm2 , and 5 for erosive/ulcerative lesions larger than 1 cm2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Background: PubMed 31478283Lavaee F, Shadmanpour M. Comparison of the effect of photodynamic therapy and topical corticosteroid on oral lichen planus lesions. Oral Dis. 2019 Nov;25(8):1954-1963. doi: 10.1111/odi.13188. Epub 2019 Oct 2.
- Background: PubMed 30006319Hoseinpour Jajarm H, Asadi R, Bardideh E, Shafaee H, Khazaei Y, Emadzadeh M. The effects of photodynamic and low-level laser therapy for treatment of oral lichen planus-A systematic review and meta-analysis. Photodiagnosis Photodyn Ther. 2018 Sep;23:254-260. doi: 10.1016/j.pdpdt.2018.07.001. Epub 2018 Jul 10.
- Background: PubMed 28450262Mostafa D, Moussa E, Alnouaem M. Evaluation of photodynamic therapy in treatment of oral erosive lichen planus in comparison with topically applied corticosteroids. Photodiagnosis Photodyn Ther. 2017 Sep;19:56-66. doi: 10.1016/j.pdpdt.2017.04.014. Epub 2017 Apr 25.
- Background: PubMed 30261326Rakesh N, Clint JB, Reddy SS, Nagi R, Chauhan P, Sharma S, Sharma P, Kaur A, Shetty B, Ashwini S, Pavan Kumar T, Vidya GS. Clinical evaluation of photodynamic therapy for the treatment of refractory oral Lichen planus - A case series. Photodiagnosis Photodyn Ther. 2018 Dec;24:280-285. doi: 10.1016/j.pdpdt.2018.09.011. Epub 2018 Sep 24.
- Derived from this study: PubMed 36678659Salinas-Gilabert C, Gomez Garcia F, Galera Molero F, Pons-Fuster E, Vander Beken S, Lopez Jornet P. Photodynamic Therapy, Photobiomodulation and Acetonide Triamcinolone 0.1% in the Treatment of Oral Lichen Planus: A Randomized Clinical Trial. Pharmaceutics. 2022 Dec 22;15(1):30. doi: 10.3390/pharmaceutics15010030.
- Individual participant dataSharing planned: Yes
Related trials for Oral Lichen Planus
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients will be treated with localized PBM with a diode laser in people with Oral Lichen Planus, run by Universidad de Murcia at 1 site in Spain.
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: finished, as of the sponsor's last update on 19 Nov 2021. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Assessment of Pain of OLP (time frame: Participants will be evaluated at baseline (Day 0) ; day 7: day 14 day and 28 day). The study lists 2 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 NCT05127083, which also lists 5 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 19 Nov 2021.