Oral Lichen PlanusPhase 4NCT03572959
Management of Pain in Oral Lichen Planus
A Phase 4 study testing 0.1 % topical triamcinolone acetonide and SIROIaser in people with Oral Lichen Planus, run by Sherine Adel Nasry.
Trial summary
Treating Oral Lichen Planus (OLP) is a big challenge for clinicians. Despite numerous existing remedies, to date no effective cure has been found, which is mainly attributed to the lack of understanding of the pathogenesis of the disease. Read more about this study
- Who is it for?
- Ages 45 to 62 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- 0.1 % topical triamcinolone acetonide and SIROIaser
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 27 Dec 2016to 22 May 2017
- Phase
- Phase 4
- 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 45 to 62 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- histological diagnosis of OLP on the basis of WHO criteria (Meji and van der Waal 2003).
- presence of painful and atrophic-erosive oral lesions, unresponsive to topical corticosteroid therapy
- ability to complete the present clinical trial.
Who cannot join
- Presence of histological signs of dysplasia
- use of lichenoid reaction inducing drugs
- Therapy for OLP in the 2 months prior to the study;
- Patients suffering from any disease that may present with features similar to OLP (graft versus host disease or lupus erythematosus)
- Pregnant or lactating females
- Patients with uncontrolled diabetes or hypertension, positive HCV Ab or HBs Ag.
- Smokers
About this study
Official title: Management of Pain in Oral Lichen Planus Patients: A Comparative Pilot Study
Treating Oral Lichen Planus (OLP) is a big challenge for clinicians. Despite numerous existing remedies, to date no effective cure has been found, which is mainly attributed to the lack of understanding of the pathogenesis of the disease. The investigator's aim was comparing the effectiveness of topical steroids and diode laser in treating OLP patients. Twenty-four patients with OLP were allocated into two groups of twelve patients each. One group was treated with 970 nm diode laser applied twice weekly and the other group was treated with topical steroids applied four times per day. Patients were followed up for two months. Pain was recorded using the visual analog score (VAS) and the clinical signs and symptoms were recorded using the reticular, atrophic, erosive (RAE) sores. Pain and RAE records were taken before treatment, after treatment and after 2 months.
Read the detailed description
24 patients (16 females , 8 males ) were recruited in this study from the Dental Clinic of the National Research Centre, Egypt, and the Ethical Committee approved the study protocol. All patients were informed about the treatment plan and they all submitted a written informed consent before enrolment, which was carried out in accordance with the declaration of Helsinki. Inclusion criteria included oral lesions clinically and histopathologically consistent with the modifications for the WHO 2003 criteria suggested by van der Meij and van der Waal.13 Patients were excluded from the study in case of indefinite diagnosis (such as lichenoid inflammation); or those suffering from any disease that may present with features similar to OLP (graft versus host disease or lupus erythematosus),if they received any medication for OLP treatment in the two months prior enrolment in the study, if they were pregnant or lactating women, or if histological diagnosis revealed lichenoid changes or any signs of dysplasia. 4,14
Study design:
Patients were randomly divided into two groups using a randomization software, where a blocked randomization was used to ascertain equal distribution of patients into each group (parallel-group study).15 One group (12 patients) was irradiated with diode laser and the other group was treated with topical steroids. In the laser group, normal protective measures were taken, where patients and personnel wore laser safety glasses . OLP lesions were irradiated with a 970-nm diode laser (SIRO Laser Advance class III b, SIRONA, Germany) with a 2 W irradiation power in a continuous non-contact mode. The laser beam was delivered using a fiber-optic tip with a 320 µm diameter with defocused mode directed at the lesions plus 0.5 cm peri- lesional tissues with a slight overlapping in order to evenly distribute energy covering all the lesional and peri-lesional tissues until blanching of the area was observed.14 Diode laser was calibrated to an output power of 3W, frequency of 30 Hz, energy of 180 joule and time interval of 8 minutes divided into 4 sessions , two min each with one minute rest in between to allow for tissue relaxation.
Irradiation was done twice weekly (once every third day) for two months until the resolution of signs (meaning the resolution of all atrophic-erosive lesions, regardless of any persisting hyperkeratotic lesions) for a maximum of ten sessions.11 After each session, patients were advised to have a cold diet and use chlorhexidine oral gel postoperatively. The patients applied the gel twice a day to the lesion for one week.16 For the steroid group (12 patients), 0.1 % topical triamcinolone acetonide preparation (Kenacourt-A Orabase Pomad, DEVA HOLDINGS A.S., Istanbul, Turkey) was used where the patients' were instructed to apply the gel 4 times daily, with no food or fluid taken one hour after application. Patients used the medication for 4 weeks , and if extension of treatment was required after that period , patients were instructed to apply miconazole oral gel (JANSSEN-CILAG Pty Ltd 1-5 Khartoum Road North Ryde NSW 2113 Australia) four times a day for one week to protect from superimposed fungal infections.15 Scoring of the clinical signs was done according to the RAE (Reticular, Erosive, Atrophic ) scale of Thongprasom and co- workers.17 Total improvement of the clinical signs was given scores zero or one and was defined as the disappearance of all atrophic-erosive lesions, whether any hyperkeratotic lesions persisted or not. Partial improvement or persisting of the patient's condition meant a decrease (score 2, 3 or 4), or no improvement (no change in the patient's score). Hence the clinical and symptomatic improvement of the patient's lesion was expressed by the numerical difference between baseline and endpoint scores. 14 Pain was recorded using the Visual Analogue Scale (VAS), which consisted of a 10-cm horizontal line, starting from 0 (designating no pain experienced by the patient to 10 (designating unbearable or most severe pain). Pain and RAE records were taken before treatment, after treatment and then after 2 months follow up.
- Conditions
- Oral Lichen Planus
- Being tested
- 0.1 % topical triamcinolone acetonide, SIROIaser
- Medical subject headings
- Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.1 % topical triamcinolone acetonideDrug
0.1 % topical triamcinolone acetonide preparation was used where the patients' were instructed to apply the gel 4 times daily, with no food or fluid taken one hour after application.
SIROIaserDevice
Oral Lichen Planus lesions were irradiated with a 970-nm diode laser with a 2 W irradiation power in a continuous non-contact mode. The laser beam was delivered using a fiber-optic tip with a 320 µm diameter with defocused mode directed at the lesions plus 0.5 cm peri- lesional tissues with a slight overlapping in order to evenly distribute energy covering all the lesional and peri-lesional tissues until blanching of the area was observed.14 Diode laser was calibrated to an output power of 3W, frequency of 30 Hz, energy of 180 joule and time interval of 8 minutes divided into 4 sessions , two min each with one minute rest in between to allow for tissue relaxation.
Irradiation was done twice weekly (once every third day) for two months until the resolution of signs for a maximum of ten sessions.
| Study group | Role | What they receive |
|---|---|---|
| comparison group (active control) | Active comparator | 0.1 % topical triamcinolone acetonide preparation (Kenacourt-A Orabase Pomad, DEVA HOLDINGS A.S., Istanbul, Turkey) was used where the patients' were instructed to apply the gel 4 times daily, with no food or fluid taken one hour after application. Patients used the medication for 4 weeks , and if extension of treatment was required after that period , patients were instructed to apply miconazole oral gel (JANSSEN-CILAG Pty Ltd 1-5 Khartoum Road North Ryde NSW 2113 Australia) four times a day for one week to protect from superimposed fungal infections.15 Receives: Drug: 0.1 % topical triamcinolone acetonide |
| experimental group | Experimental | OLP lesions were irradiated with a 970-nm diode laser (SIRO Laser Advance class III b, SIRONA, Germany) with a 2 W irradiation power in a continuous non-contact mode. The laser beam was delivered using a fiber-optic tip with a 320 µm diameter with defocused mode directed at the lesions plus 0.5 cm peri- lesional tissues with a slight overlapping in order to evenly distribute energy covering all the lesional and peri-lesional tissues until blanching of the area was observed.14 Diode laser was calibrated to an output power of 3W, frequency of 30 Hz, energy of 180 joule and time interval of 8 minutes divided into 4 sessions , two min each with one minute rest in between to allow for tissue relaxation.
Irradiation was done twice weekly for two months until the resolution of signs for a maximum of ten sessions.11 After each session, patients were advised to have a cold diet and use chlorhexidine oral gel postoperatively twice a day to the lesion for one week. Receives: Device: SIROIaser |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in VAS
Visual Analogue Scale (VAS) The pain VAS is a continuous single-item scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme Range: 0-10 (cm) no pain (0-0.4 cm), mild pain (0.55-4.4 cm), moderate pain (4.5-7.4)cm, and severe pain (7.5- 10) cm A higher score indicates greater pain intensity
Measured: two months
Secondary outcomes (1)
change in RAE
The Reticular, Atrohpic, Erosive ( RAE ) scale used by Thongprasom and co-workers records and measures the clinical appearance of the Oral Lichen Planus) OLP lesion Score range: 0-5 with o being the most favorable clinical appearance and 5 the most severe clinical appearance.
score 0: no lesions; score 1: hyperkeratotic lesions score 2: atrophic area ≤1 cm2 score 3: atrophic area >1 cm2 score 4: erosive area ≤1 cm2 score 5: erosive area >1 cm2
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start27 Dec 2016
- Primary completion20 Mar 2017
- Study completion22 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sherine Adel Nasry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherine Adel Nasry, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572959
- Sponsor's protocol ID
- 15023
- Status last verified
- Jun 2018
- First submitted
- 19 Jun 2018
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Pain in Oral Lichen Planus Patients: A Comparative Pilot Study
- ClinicalTrials.gov ID
- NCT03572959
- Acronym / sponsor ID
- 15023
- Conditions
- Oral Lichen Planus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sherine Adel NasryUniversity, hospital or other
- Study start
- 27 Dec 2016 (actual)
- Primary completion
- 20 Mar 2017 (actual)
- Study completion
- 22 May 2017 (actual)
- First posted
- 28 Jun 2018 (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.
Treating Oral Lichen Planus (OLP) is a big challenge for clinicians. Despite numerous existing remedies, to date no effective cure has been found, which is mainly attributed to the lack of understanding of the pathogenesis of the disease. The investigator's aim was comparing the effectiveness of topical steroids and diode laser in treating OLP patients. Twenty-four patients with OLP were allocated into two groups of twelve patients each. One group was treated with 970 nm diode laser applied twice weekly and the other group was treated with topical steroids applied four times per day. Patients were followed up for two months. Pain was recorded using the visual analog score (VAS) and the clinical signs and symptoms were recorded using the reticular, atrophic, erosive (RAE) sores. Pain and RAE records were taken before treatment, after treatment and after 2 months.
Detailed description
24 patients (16 females , 8 males ) were recruited in this study from the Dental Clinic of the National Research Centre, Egypt, and the Ethical Committee approved the study protocol. All patients were informed about the treatment plan and they all submitted a written informed consent before enrolment, which was carried out in accordance with the declaration of Helsinki. Inclusion criteria included oral lesions clinically and histopathologically consistent with the modifications for the WHO 2003 criteria suggested by van der Meij and van der Waal.13 Patients were excluded from the study in case of indefinite diagnosis (such as lichenoid inflammation); or those suffering from any disease that may present with features similar to OLP (graft versus host disease or lupus erythematosus),if they received any medication for OLP treatment in the two months prior enrolment in the study, if they were pregnant or lactating women, or if histological diagnosis revealed lichenoid changes or any signs of dysplasia. 4,14
Study design:
Patients were randomly divided into two groups using a randomization software, where a blocked randomization was used to ascertain equal distribution of patients into each group (parallel-group study).15 One group (12 patients) was irradiated with diode laser and the other group was treated with topical steroids. In the laser group, normal protective measures were taken, where patients and personnel wore laser safety glasses . OLP lesions were irradiated with a 970-nm diode laser (SIRO Laser Advance class III b, SIRONA, Germany) with a 2 W irradiation power in a continuous non-contact mode. The laser beam was delivered using a fiber-optic tip with a 320 µm diameter with defocused mode directed at the lesions plus 0.5 cm peri- lesional tissues with a slight overlapping in order to evenly distribute energy covering all the lesional and peri-lesional tissues until blanching of the area was observed.14 Diode laser was calibrated to an output power of 3W, frequency of 30 Hz, energy of 180 joule and time interval of 8 minutes divided into 4 sessions , two min each with one minute rest in between to allow for tissue relaxation.
Irradiation was done twice weekly (once every third day) for two months until the resolution of signs (meaning the resolution of all atrophic-erosive lesions, regardless of any persisting hyperkeratotic lesions) for a maximum of ten sessions.11 After each session, patients were advised to have a cold diet and use chlorhexidine oral gel postoperatively. The patients applied the gel twice a day to the lesion for one week.16 For the steroid group (12 patients), 0.1 % topical triamcinolone acetonide preparation (Kenacourt-A Orabase Pomad, DEVA HOLDINGS A.S., Istanbul, Turkey) was used where the patients' were instructed to apply the gel 4 times daily, with no food or fluid taken one hour after application. Patients used the medication for 4 weeks , and if extension of treatment was required after that period , patients were instructed to apply miconazole oral gel (JANSSEN-CILAG Pty Ltd 1-5 Khartoum Road North Ryde NSW 2113 Australia) four times a day for one week to protect from superimposed fungal infections.15 Scoring of the clinical signs was done according to the RAE (Reticular, Erosive, Atrophic ) scale of Thongprasom and co- workers.17 Total improvement of the clinical signs was given scores zero or one and was defined as the disappearance of all atrophic-erosive lesions, whether any hyperkeratotic lesions persisted or not. Partial improvement or persisting of the patient's condition meant a decrease (score 2, 3 or 4), or no improvement (no change in the patient's score). Hence the clinical and symptomatic improvement of the patient's lesion was expressed by the numerical difference between baseline and endpoint scores. 14 Pain was recorded using the Visual Analogue Scale (VAS), which consisted of a 10-cm horizontal line, starting from 0 (designating no pain experienced by the patient to 10 (designating unbearable or most severe pain). Pain and RAE records were taken before treatment, after treatment and then after 2 months follow up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| comparison group (active control) | Active comparator | Drug: 0.1 % topical triamcinolone acetonide0.1 % topical triamcinolone acetonide preparation (Kenacourt-A Orabase Pomad, DEVA HOLDINGS A.S., Istanbul, Turkey) was used where the patients' were instructed to apply the gel 4 times daily, with no food or fluid taken one hour after application. Patients used the medication for 4 weeks , and if extension of treatment was required after that period , patients were instructed to apply miconazole oral gel (JANSSEN-CILAG Pty Ltd 1-5 Khartoum Road North Ryde NSW 2113 Australia) four times a day for one week to protect from superimposed fungal infections.15 |
| experimental group | Experimental | Device: SIROIaserOLP lesions were irradiated with a 970-nm diode laser (SIRO Laser Advance class III b, SIRONA, Germany) with a 2 W irradiation power in a continuous non-contact mode. The laser beam was delivered using a fiber-optic tip with a 320 µm diameter with defocused mode directed at the lesions plus 0.5 cm peri- lesional tissues with a slight overlapping in order to evenly distribute energy covering all the lesional and peri-lesional tissues until blanching of the area was observed.14 Diode laser was calibrated to an output power of 3W, frequency of 30 Hz, energy of 180 joule and time interval of 8 minutes divided into 4 sessions , two min each with one minute rest in between to allow for tissue relaxation. Irradiation was done twice weekly for two months until the resolution of signs for a maximum of ten sessions.11 After each session, patients were advised to have a cold diet and use chlorhexidine oral gel postoperatively twice a day to the lesion for one week. |
Who may qualify
- Ages
- 45 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- histological diagnosis of OLP on the basis of WHO criteria (Meji and van der Waal 2003).
- presence of painful and atrophic-erosive oral lesions, unresponsive to topical corticosteroid therapy
- ability to complete the present clinical trial.
Key exclusion criteria (7 listed)
- Presence of histological signs of dysplasia
- use of lichenoid reaction inducing drugs
- Therapy for OLP in the 2 months prior to the study;
- Patients suffering from any disease that may present with features similar to OLP (graft versus host disease or lupus erythematosus)
- Pregnant or lactating females
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 |
|---|---|---|
| 0.1 % topical triamcinolone acetonide0.1 % topical triamcinolone acetonide preparation was used where the patients' were instructed to apply the gel 4 times daily, with no food or fluid taken one hour after application. | Drug | comparison group (active control) |
| SIROIaserOral Lichen Planus lesions were irradiated with a 970-nm diode laser with a 2 W irradiation power in a continuous non-contact mode. The laser beam was delivered using a fiber-optic tip with a 320 µm diameter with defocused mode directed at the lesions plus 0.5 cm peri- lesional tissues with a slight overlapping in order to evenly distribute energy covering all the lesional and peri-lesional tissues until blanching of the area was observed.14 Diode laser was calibrated to an output power of 3W, frequency of 30 Hz, energy of 180 joule and time interval of 8 minutes divided into 4 sessions , two min each with one minute rest in between to allow for tissue relaxation. Irradiation was done twice weekly (once every third day) for two months until the resolution of signs for a maximum of ten sessions. | Device | experimental group |
Primary outcome
change in VAS
Time frame: two months
Visual Analogue Scale (VAS) The pain VAS is a continuous single-item scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme Range: 0-10 (cm) no pain (0-0.4 cm), mild pain (0.55-4.4 cm), moderate pain (4.5-7.4)cm, and severe pain (7.5- 10) cm A higher score indicates greater pain intensity
1 secondary outcome
change in RAE
Time frame: two months
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 3 Jul 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.1 % topical triamcinolone acetonide and SIROIaser in people with Oral Lichen Planus, run by Sherine Adel Nasry.
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 3 inclusion and 7 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 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 in VAS (time frame: two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2018.