Oral Lichen PlanusPhase 2NCT03592342
Intra-oral Treatment of OLP With Rivelin®-CLO Patches
A Phase 2 study testing Clobetasol Propionate in people with Oral Lichen Planus, run by Dermtreat at 27 sites in 6 countries.
Trial summary
Participants with symptomatic Oral Lichen Planus lesions will be treated with Rivelin® patches containing either 0, 1, 5, or 20 μg clobetasol per patch. Each participant will apply up to 6 patches twice daily for 4 weeks. 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?
- Clobetasol Propionate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 27 sitesin 6 countries
- Study dates
- 28 Jun 2018to 20 Dec 2019
- Phase
- Phase 2
- 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
- OLP patients with at least one visible and measurable symptomatic ulcerative OLP lesion, assessable via OLP Clinician Reported Outcome Measure (OLPClinROM).
- Diagnosis of LP histologically confirmed by result of either an existing clinically relevant biopsi or a new clinically representative biopsy at first screening visit (i.e. a biopsy report either indicative of OLP, LP or indicative of lichenoid inflammation will be sufficient).
- Patients aged ≥ 18 years.
- Patients practicing daily oral hygiene (by tooth brushing and/or mouth rinse) and willing to maintain at least their routine oral hygiene procedure during study participation.
- Willingness to keep already used permitted concomitant medication, food supplements (e.g. probiotics) or herbals, which might have in the discretion of the investigator a potential influence on OLP, on a stable basis during the study.
Who cannot join
- Patients requiring more than 6 patches (corresponding to an area of approximately 3 cm2 per patch) to cover symptomatic ulcerative and erythematous OLP lesions at baseline visit.
- Ongoing active visible fungal, bacterial or viral infection of oral mucosa, including ongoing treatment of those at baseline.
- Patient with any un-healed oral surgery (including recent diagnostic biopsies, if applicable) or oral laser therapeutic wound(s) at baseline visit.
- Any of the following systemic treatments prior to baseline visit and throughout the study:
- Protease inhibitors used for the treatment of HIV (e.g. atazanavir, idinavir, nelfinavir, etc.): 1 week
- Corticosteroids (i.v., intra articular, intra-lesional): 4 weeks
Show all 26Show fewer
- Antimycotics: 4 weeks The following systemic treatments are allowed, if on stable dose for a defined period of time to baseline and throughout the study.
- Antibiotics: 4 weeks
- Corticosteroids (oral, rectal, inhalative) washout/stable with maxinum dose of 10 mg daily prednisolone or equivalent for 4 weeks.
- Retinoids: 12 weeks
- Immunosuppressive drugs (e.g. azathioprine, cyclosporine, mycophenolate mofetil, or biologics): 12 weeks
- Any of the following topical treatments used in the oral cavity prior to baseline visit:
- Corticosteroids: 2 weeks
- Antibiotics: 2 weeks
- Cyclosporine: 2 weeks
- Tacrolimus, pimecrolimus: 2 weeks
- Antimycotics: 2 weeks
- Retinoids: 4 weeks
- Phototherapy in oral cavity prior to baseline visit: UVB, PUVA.
- Current participation in another clinical study and/or having received treatment with any non-marketed / investigational medicinal product (drug substance or medical device) within 4 weeks prior to screening.
- Known or suspected intolerance/hypersensitivity/resistance to clobetasol propionate or any component of the investigational medicinal product.
- Any history of squamous cell carcinoma (even if resected), as well as history of other non-squamous cell carcinoma (e.g. sarcoma, salivary gland tumors) that have been managed with radiation or chemotherapy.
- History of cancer (except resected cutaneous basal cell carcinoma and except in situ cervical cancer) unless it can be documented that the patient has been in a disease-free state for at least 5 years, or at least 2 years in a disease-free state for low-grade cancers. In case of clinical suspicion of malignancy in the oral cavity, a patient can only be included after an excluding biopsy.
- Professional dental cleaning within 2 weeks prior to baseline and unwillingness to refrain from professional dental cleaning during study conduct.
- Close affiliation with the investigator (e.g. a close relative) or persons working at the study sites or patient who is an employee of the Sponsor's company.
- Pregnant, confirmed by a positive pregnancy test, or nursing (lactating) women, or women of childbearing potential (WOCP) planning to become pregnant or WOCP not using or willing to continue to use a defined highly effective method of contraception throughout the study.
Trial locations and contacts
27 sites in 6 countries.
27 sites in 6 countries
United States14 sites
The Dental College of Georgia
Augusta, Georgia, 30912
Tufts University, School of Dental Medicine
Boston, Massachusetts, 02111
Brigham and Women's Hospital, Division of Oral Medicine and Dentistry
Boston, Massachusetts, 02115
UNC Dermatology and Skin Cancer Center
Chapel Hill, North Carolina, 27516
Carolinas Center for Oral Health
Charlotte, North Carolina, 28209
The Oral and Facial Surgery Center
Clearfield, Utah, 84105
Texas A&M University (TAMU), College of Dentistry
Dallas, Texas, 75246
UT Southwestern Medical Center Department of Surgery
Dallas, Texas, 75390-9109
ENT Associates of Texas
Frisco, Texas, 75035
QWay Research
Hialeah, Florida, 33010
Vitae Research Center, LLC
Miami, Florida, 33135
Valencia Medical & Research Center
Miami, Florida, 33165
NYU College of Dentistry, Bluestone Center for Clinical Research
New York, New York, 10010
University of Pennsylvania Health System, Dept. Oral amd Maxillofacial Surgery
Philadelphia, Pennsylvania, 19104
United Kingdom7 sites
Edinburgh Dental Institute
Edinburgh, EH3 9HA
University of Glasgow Dental School
Glasgow, G2 3JZ
Leeds Dental Institute
Leeds, LS9 9LU
King´s College London Dental Institute, Oral Clinical Research Unit
London, SE1 9RT
University College London and University College London Hospitals Trust
London, WC1X 8LD
School of Dental Sciences Newcastel Upon Tyne
Newcastle upon Tyne, Newcastel, NE2 4BW
University of Sheffield, School of Clinical Dentistry
Sheffield, S10 2TA
Canada2 sites
Kaye Edmonton Clinic
Edmonton, Alberta, T6G1Z1
Health Sciences North, North East Cancer Center
Greater Sudbury, Ontario, P3E5JL
Denmark2 sites
Rigshospitalet
Copenhagen, 2100
University of Copenhagen Department of Odontology
Copenhagen, 2100
Germany1 site
LMU München, Klinik und Poliklinik für Dermatologie und Allergologie
Munich, 80337
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Clinical Study to Assess the Safety and Efficacy of Three Doses of Clobetasol Propionate When Administered Intra-orally Twice Daily in Patients With Oral Lichen Planus (OLP) Using Rivelin®-CLO Patches
Participants with symptomatic Oral Lichen Planus lesions will be treated with Rivelin® patches containing either 0, 1, 5, or 20 μg clobetasol per patch. Each participant will apply up to 6 patches twice daily for 4 weeks.
Read the detailed description
Randomized, double-blind, placebo-controlled, parallel group clinical study with 3 active dose arms (Rivelin®-CLO patches) and one placebo arm (Rivelin® plain patch). Up to 6 Rivelin® patches will be applied to symptomatic ulcerative and symptomatic erythematous OLP lesions.
After screening (visit 1, day -14 to day -7), patients who have signed the informed consent form and who are fulfilling the inclusion criteria and none of the exclusion criteria will be randomized at baseline (visit 2, day 1) to one of the four treatment arms in a double-blinded fashion.
- Arm A: Rivelin® plain patch (Placebo)
- Arm B: Rivelin®-CLO 1 μg/patch
- Arm C: Rivelin®-CLO 5 μg/patch
- Arm D: Rivelin®-CLO 20 μg/patch Randomization will be 1:1:1:1 and patients will be stratified according to number of patches needed (1-3 and 4-6).
The screening phase ranges between 7 and 14 days, i.e. that the screening visit (visit 1) needs to be performed 7 days prior to baseline at latest. For visits 3 (day 8), 4 (day 15), 5 (day 22), and 6 (day 29) a visit window of +/- 2 days will be allowed. Visit 7 will be defined as visit 6 + 14 days, with a visit window of +/- 3 days.
Randomized patients will enter a 28-days (4-weeks) treatment period. Dosing is two times per day (morning and evening) with patches applied directly on OLP lesions as instructed by a clinician or delegated site staff. Patients will record symptoms and adhesion time in daily diaries by using an electronic diary (eDiary).
During the treatment period, the treating physician or dentist will perform an assessment of the disease status on a weekly basis. A final examination of disease status will be performed at the follow-up visit (visit 7), 14 days after the end of treatment.
Other treatments of symptomatic OLP lesions during the study are prohibited. Only rescue analgesics determined by the investigator at study entry on a patient specific basis are allowed to be taken, in case that OLP associated symptoms like pain cannot be managed by the sole use of the patches. All doses of rescue analgesics will be recorded by the patient in the eDiary.
If the patients' condition is worsening (at the discretion of the investigator) and if associated symptoms cannot longer be managed acceptably by the additional use of rescue analgesics, i.e. if there is the need to start any other OLP treatment, IMP treatment for that patient should be discontinued prematurely and patient should be withdrawn from the study.
At visit 3 (day 8), a blood sample will be drawn to measure the blood plasma concentration of clobetasol and to determine the morning serum cortisol level (between 7 and 9 AM).
All patients will have a follow-up visit that will be performed 2 weeks after the EoT/ET visit (visit 6).
Safety data (by means of AE documentation including fungal infections and SAE reporting) will be closely monitored by an independent Data and Safety Monitoring Board (DSMB). DSMB will advise the Sponsor of any potential risk for the safeguard of patients.
- Conditions
- Oral Lichen Planus
- Being tested
- Clobetasol Propionate
- Keywords
- Patch, Rivelin-Clo Patch, Oral Lichen Planus, Ulcerative, Erythematous, OLP, OLPClinROM, OLPSSM
- Medical subject headings
- Lichen Planus, Oral, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clobetasol PropionateDrug
Rivelin® patch is a two-layer patch comprised of a muco-adhesive, drug-delivery layer and a protective layer.
| Study group | Role | What they receive |
|---|---|---|
| Rivelin® plain patches | Placebo comparator | Dosing is two times per day (morning and evening) with Rivelin® plain patches (placebo). Receives: Drug: Clobetasol Propionate |
| Rivelin®-CLO patch 1µg | Experimental | Dosing is two times per day (morning and evening) with Rivelin®-CLO patch 1µg Clobetasol propionate per patch. Receives: Drug: Clobetasol Propionate |
| Rivelin®-CLO patch 5µg | Experimental | Dosing is two times per day (morning and evening) with Rivelin®-CLO patch 5µg Clobetasol propionate per patch. Receives: Drug: Clobetasol Propionate |
| Rivelin®-CLO patch 20µg | Experimental | Dosing is two times per day (morning and evening) with Rivelin®-CLO patch 20µg Clobetasol propionate per patch. Receives: Drug: Clobetasol Propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ulcer area
The change will be calculated from baseline to end of trial
Measured: 4 weeks
Secondary outcomes (9)
Change in lesion area
The change will be calculated from baseline to end of trial
Measured: 4 weeks
Change in 5-point erythema score
The change will be calculated from baseline to end of trial using a 5-point erythema score (assessed as no redness (0) or very severe redness (4))
Measured: 4 weeks
Change in Clinical global impression score
The change will be calculated from baseline to end of trial using the Clinical Global Impression Score assessed on a 5-point rating scale ranging between no disease (0) and very severe disease (4)
Measured: 4 weeks
Change in OLPSSM total score (item #1 to #7)
The change will be calculated from baseline to end of trial. The OLPSSM (OLP Symptom Severity Measure) is a recently developed questionnaire, which serves for the patient to assess his/her specific OLP symptoms. This questionnaire consists of overall 12 items, to be assessed at different time points. Most items should be completed on a daily basis (in the evening). These items will be assessed as part of the patient's eDiary
Measured: 4 weeks
Change in individual diary symptom scores (item #1 to #7 of the OLPSSM)
The change will be calculated from baseline to end of trial. The OLPSSM (OLP Symptom Severity Measure) is a recently developed questionnaire, which serves for the patient to assess his/her specific OLP symptoms. This questionnaire consists of overall 12 items, to be assessed at different time points. Most items should be completed on a daily basis (in the evening). These items will be assessed as part of the patient's eDiary.
Measured: 4 weeks
Change in worst symptoms at anatomical sites
The change will be calculated from baseline to end of trial
Measured: 4 weeks
The proportion of positive outcomes (score 0 or 1) on each of the 11 questions in the Patch Sensation Questionnaire
The patient will assess the sensation of wearing the Rivelin® patches by answering 11 questions (the Patch sensation questionnaire) according to 5-point rating scales (ranging between 0 [most positive response] and 4 [most negative response]).The Patch Sensation Questionnaire will be completed during the clinic visit at baseline (visit 2) after first patch application and at visit 4 (2 weeks).
Measured: 2 weeks
The proportion of patients with successful (>=80% of days on treatment) patch applications
Defined as an adhesion time more than 30 minutes during the 4 weeks treatment
Measured: 4 weeks
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Frequency and intensity of adverse events (AEs) reported during the study
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start28 Jun 2018
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization will be 1:1:1:1 to 1 of the 4 parallel arms (3 active and 1 placebo) and patients will be stratified according to number of patches needed (1-3 and 4-6).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dermtreat
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Proinnovera GmbH, X-act Cologne Clinical Research GmbH
- Responsible party
- Sponsor
- Investigators
- Lars Siim Madsen, PhD, Study chair, DermtreatMichael Brennan, DDS, Principal investigator, Carolinas Healthcare System, Dept. of Oral Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592342
- Sponsor's protocol ID
- DT-001-R-004
- Status last verified
- Jul 2020
- First submitted
- 19 Jun 2018
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Group Clinical Study to Assess the Safety and Efficacy of Three Doses of Clobetasol Propionate When Administered Intra-orally Twice Daily in Patients With Oral Lichen Planus (OLP) Using Rivelin®-CLO Patches
- ClinicalTrials.gov ID
- NCT03592342
- Acronym / sponsor ID
- DT-001-R-004
- Conditions
- Oral Lichen Planus
- Keywords
- Patch, Rivelin-Clo Patch, Oral Lichen Planus, Ulcerative, Erythematous, OLP, OLPClinROM, OLPSSM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- DermtreatIndustry (pharma, biotech, devices)
- Collaborators
- Proinnovera GmbH, X-act Cologne Clinical Research GmbH
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 19 Jul 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.
Participants with symptomatic Oral Lichen Planus lesions will be treated with Rivelin® patches containing either 0, 1, 5, or 20 μg clobetasol per patch. Each participant will apply up to 6 patches twice daily for 4 weeks.
Detailed description
Randomized, double-blind, placebo-controlled, parallel group clinical study with 3 active dose arms (Rivelin®-CLO patches) and one placebo arm (Rivelin® plain patch). Up to 6 Rivelin® patches will be applied to symptomatic ulcerative and symptomatic erythematous OLP lesions.
After screening (visit 1, day -14 to day -7), patients who have signed the informed consent form and who are fulfilling the inclusion criteria and none of the exclusion criteria will be randomized at baseline (visit 2, day 1) to one of the four treatment arms in a double-blinded fashion.
- Arm A: Rivelin® plain patch (Placebo)
- Arm B: Rivelin®-CLO 1 μg/patch
- Arm C: Rivelin®-CLO 5 μg/patch
- Arm D: Rivelin®-CLO 20 μg/patch Randomization will be 1:1:1:1 and patients will be stratified according to number of patches needed (1-3 and 4-6).
The screening phase ranges between 7 and 14 days, i.e. that the screening visit (visit 1) needs to be performed 7 days prior to baseline at latest. For visits 3 (day 8), 4 (day 15), 5 (day 22), and 6 (day 29) a visit window of +/- 2 days will be allowed. Visit 7 will be defined as visit 6 + 14 days, with a visit window of +/- 3 days.
Randomized patients will enter a 28-days (4-weeks) treatment period. Dosing is two times per day (morning and evening) with patches applied directly on OLP lesions as instructed by a clinician or delegated site staff. Patients will record symptoms and adhesion time in daily diaries by using an electronic diary (eDiary).
During the treatment period, the treating physician or dentist will perform an assessment of the disease status on a weekly basis. A final examination of disease status will be performed at the follow-up visit (visit 7), 14 days after the end of treatment.
Other treatments of symptomatic OLP lesions during the study are prohibited. Only rescue analgesics determined by the investigator at study entry on a patient specific basis are allowed to be taken, in case that OLP associated symptoms like pain cannot be managed by the sole use of the patches. All doses of rescue analgesics will be recorded by the patient in the eDiary.
If the patients' condition is worsening (at the discretion of the investigator) and if associated symptoms cannot longer be managed acceptably by the additional use of rescue analgesics, i.e. if there is the need to start any other OLP treatment, IMP treatment for that patient should be discontinued prematurely and patient should be withdrawn from the study.
At visit 3 (day 8), a blood sample will be drawn to measure the blood plasma concentration of clobetasol and to determine the morning serum cortisol level (between 7 and 9 AM).
All patients will have a follow-up visit that will be performed 2 weeks after the EoT/ET visit (visit 6).
Safety data (by means of AE documentation including fungal infections and SAE reporting) will be closely monitored by an independent Data and Safety Monitoring Board (DSMB). DSMB will advise the Sponsor of any potential risk for the safeguard of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomization will be 1:1:1:1 to 1 of the 4 parallel arms (3 active and 1 placebo) and patients will be stratified according to number of patches needed (1-3 and 4-6).
| Arm | Type | Receives |
|---|---|---|
| Rivelin® plain patches | Placebo comparator | Drug: Clobetasol PropionateDosing is two times per day (morning and evening) with Rivelin® plain patches (placebo). |
| Rivelin®-CLO patch 1µg | Experimental | Drug: Clobetasol PropionateDosing is two times per day (morning and evening) with Rivelin®-CLO patch 1µg Clobetasol propionate per patch. |
| Rivelin®-CLO patch 5µg | Experimental | Drug: Clobetasol PropionateDosing is two times per day (morning and evening) with Rivelin®-CLO patch 5µg Clobetasol propionate per patch. |
| Rivelin®-CLO patch 20µg | Experimental | Drug: Clobetasol PropionateDosing is two times per day (morning and evening) with Rivelin®-CLO patch 20µg Clobetasol propionate per patch. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- OLP patients with at least one visible and measurable symptomatic ulcerative OLP lesion, assessable via OLP Clinician Reported Outcome Measure (OLPClinROM).
- Diagnosis of LP histologically confirmed by result of either an existing clinically relevant biopsi or a new clinically representative biopsy at first screening visit (i.e. a biopsy report either indicative of OLP, LP or indicative of lichenoid inflammation will be sufficient).
- Patients aged ≥ 18 years.
- Patients practicing daily oral hygiene (by tooth brushing and/or mouth rinse) and willing to maintain at least their routine oral hygiene procedure during study participation.
- Willingness to keep already used permitted concomitant medication, food supplements (e.g. probiotics) or herbals, which might have in the discretion of the investigator a potential influence on OLP, on a stable basis during the study.
Key exclusion criteria (26 listed)
- Patients requiring more than 6 patches (corresponding to an area of approximately 3 cm2 per patch) to cover symptomatic ulcerative and erythematous OLP lesions at baseline visit.
- Ongoing active visible fungal, bacterial or viral infection of oral mucosa, including ongoing treatment of those at baseline.
- Patient with any un-healed oral surgery (including recent diagnostic biopsies, if applicable) or oral laser therapeutic wound(s) at baseline visit.
- Any of the following systemic treatments prior to baseline visit and throughout the study:
- Any of the following topical treatments used in the oral cavity prior to baseline visit:
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 |
|---|---|---|
| Clobetasol PropionateRivelin® patch is a two-layer patch comprised of a muco-adhesive, drug-delivery layer and a protective layer. | Drug | Rivelin® plain patches, Rivelin®-CLO patch 1µg, Rivelin®-CLO patch 20µg, Rivelin®-CLO patch 5µg |
Primary outcome
Change in ulcer area
Time frame: 4 weeks
The change will be calculated from baseline to end of trial
9 secondary outcomes
Change in lesion area
Time frame: 4 weeks
Change in 5-point erythema score
Time frame: 4 weeks
Change in Clinical global impression score
Time frame: 4 weeks
Change in OLPSSM total score (item #1 to #7)
Time frame: 4 weeks
Change in individual diary symptom scores (item #1 to #7 of the OLPSSM)
Time frame: 4 weeks
Change in worst symptoms at anatomical sites
Time frame: 4 weeks
The proportion of positive outcomes (score 0 or 1) on each of the 11 questions in the Patch Sensation Questionnaire
Time frame: 2 weeks
The proportion of patients with successful (>=80% of days on treatment) patch applications
Time frame: 4 weeks
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: 4 weeks
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 14 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
Lars Siim Madsen, PhD study chair
Dermtreat
Michael Brennan, DDS principal investigator
Carolinas Healthcare System, Dept. of Oral Medicine
27 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clobetasol Propionate in people with Oral Lichen Planus, run by Dermtreat at 27 sites in 6 countries.
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 5 inclusion and 26 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 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, United Kingdom, Canada, Denmark, Germany and 1 more country. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 ulcer area (time frame: 4 weeks). 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 14 Jul 2020.