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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
140
Rivelin® patch is a two-layer patch comprised of a muco-adhesive, drug-delivery layer and a protective layer.
Change in ulcer area
The change will be calculated from baseline to end of trial
Time frame: 4 weeks
Change in lesion area
The change will be calculated from baseline to end of trial
Time frame: 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))
Time frame: 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)
Time frame: 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
Time frame: 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.
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QWay Research
Hialeah, Florida, United States
Vitae Research Center, LLC
Miami, Florida, United States
Valencia Medical & Research Center
Miami, Florida, United States
The Dental College of Georgia
Augusta, Georgia, United States
Tufts University, School of Dental Medicine
Boston, Massachusetts, United States
Brigham and Women's Hospital, Division of Oral Medicine and Dentistry
Boston, Massachusetts, United States
NYU College of Dentistry, Bluestone Center for Clinical Research
New York, New York, United States
UNC Dermatology and Skin Cancer Center
Chapel Hill, North Carolina, United States
Carolinas Center for Oral Health
Charlotte, North Carolina, United States
University of Pennsylvania Health System, Dept. Oral amd Maxillofacial Surgery
Philadelphia, Pennsylvania, United States
...and 17 more locations
Time frame: 4 weeks
Change in worst symptoms at anatomical sites
The change will be calculated from baseline to end of trial
Time frame: 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).
Time frame: 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
Time frame: 4 weeks
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Frequency and intensity of adverse events (AEs) reported during the study
Time frame: 4 weeks