Oral Lichen Planus (OLP). OLP is a common, chronic mucosal disease associated with a cell-mediated immunological dysfunction and characterized by exacerbations of inflammation, which can lead to ulcerations of the oral mucosa associated with pain and discomfort including oral burning sensations. MedDRA version: 20.1 Level: PT Classification code 10030983 Term: Oral lichen planus System Organ Class: 10017947 - Gastr
Conditions
Interventions
Product Name: Rivelin®-CLO patch
Pharmaceutical Form: Oromucosal patch
INN or Proposed INN: CLOBETASOL PROPIONATE
CAS Number: 25122-46-7
Sponsors
Afyx Therapeutics A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. OLP patients with at least one visible and measurable symptomatic ulcerative OLP lesion , assessable via OLP Clinician Reported Outcome Measure (OLPClinROM). 2. Clinical diagnosis of symptomatic OLP supported by the Oral Lichen Planus Symptom Severity Measure (OLPSSM): The sum score of individual items #1 to #7 of the OLPSSM has to be 5 or more on at least 4 days (consecutive or not consecutive) during the last week prior to baseline/randomization visit. 3. Diagnosis of LP histologically confirmed by result of either an existing clinically relevant biopsy or a new clinically representative biopsy taken at first screening visit (i.e., a biopsy report either indicative of OLP, LP or indicative of lichenoid inflammation will be sufficient). 4. The written informed consent form has been signed and dated by the patient following receipt of verbal and written information about the study prior to carry out any study related activity. 5. Patients aged = 18 years. 6. 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. 7. 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 from second screening (visit 1) to the end of study (visit 7). 8. Only if a diagnostic biopsy needs to be taken at first screening visit: Complete healing of biopsy wound, including complete relief of pain associated with the biopsy site (defined as no / no further need to use any pain relief medication) at date of the second screening visit (visit 1). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: 1. 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. 2. Ongoing active visible fungal, bacterial or viral infection of oral mucosa, including ongoing treatment of fungal or bacterial infection at second screening visit (visit 1) and/or at baseline visit. 3. Patient with any not completely healed oral surgery (including recent diagnostic biopsies, if applicable) or oral laser therapeutic wound(s) at second screening visit (visit 1). 4. 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 - Antimycotics: 4 weeks - Corticosteroids (i.v., intra-lesional, intra-articular): 4 weeks Note: intra-articular injections for the treatment of concomitant conditions (e.g. RA, activated arthrosis, acute gout, etc.) will be allowed if needed for non-OLP related disease flares during the study. The following systemic treatments are allowed, if on stable dose for a defined period of time prior to baseline (as stated below) and throughout the study. If not on stable dose as defined, these treatments are forbidden throughout the study and have to be washed out for the periods of time prior to baseline (as stated below): - Corticosteroids (oral, rectal, inhalative) washout/stable with maximum dose of 10 mg daily prednisolone or equivalent for 4 weeks - Antibiotics: wash-out/stable for 4 weeks - Retinoids: wash-out/stable for 12 weeks - Immunosuppressive drugs (e.g. azathioprine, cyclosporine, mycophenolate mofetil, hydroxychloroquine or biologics): wash-out/stable for 12 weeks 5. 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 6. Phototherapy in oral cavity prior to baseline visit: UVB: 2 weeks, PUVA: 4 weeks. 7. 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 the first screening visit (visit 0). 8. Known or suspected intolerance/hypersensitivity/resistance to clobetasol propionate or any component of the investigational medicinal product. 9. Note: former exclusion criterion #9 was deleted as a consequence of amendment 04. 10. Any history of oral 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. 11. History of cancer (except resected cutaneous basal cell carcinoma, except resected cutaneous squamous cell carcinoma and except resected 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 dis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To demonstrate the efficacy of three different doses of Rivelin®-CLO patches in treating OLP lesions over 4 weeks of treatment assessed by change in ulcer area.;Primary end point(s): 1. Change in ulcer area from baseline (visit 2) to average of visit 5 and visit 6.;Timepoint(s) of evaluation of this end point: At the end of the 4 weeks treatment period; Secondary Objective: 1. To demonstrate the efficacy of 3 doses of Rivelin®-CLO patches in treating OLP lesions over 4 weeks assessed by change in lesion area. 2. To demonstrate the efficacy of 3 doses of Rivelin®-CLO patches in treating OLP lesions over 4 weeks assessed by change in 5-point erythema score. 3. To demonstrate the efficacy of 3 doses of Rivelin®-CLO patches in treating OLP lesions over 4 weeks assessed by change in Clinical global impression of anatomical site score. 4. To demonstrate the effect on patient reported daily symptoms (OLPSSM) when OLP lesions are treated by 3 doses of Rivelin®-CLO patches over 4 weeks. 5. To investigate the comfort and sensation of wearing the Rivelin®-CLO and Rivelin® plain patches after first administration and after 2 weeks of treatment. 6. To investigate the adhesion time of Rivelin®-CLO and Rivelin® plain patches applied to one OLP lesion over 4 weeks of treatment. 7. To evaluate the safety of Rivelin®-CLO patches in treating OLP lesions over 4 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. a) Change in lesion area from baseline to average of visit 5 and visit 6 1. b) Change in 5-point erythema score from baseline to average of visit 5 and visit 6. 1. c) Change in Clinical global impression of anatomical site score from baseline to average of visit 5 and visit 6. 2. a) Change in OLPSSM total score (item #1 to #7) from baseline (run-in mean) to mean over weeks 3 and 4. 2. b) Change in individual diary symptom scores (item #1 to #7 of the OLPSSM) from baseline (run-in mean) to mean over weeks 3 and 4. 3. Change in worst symptoms at anatomical sites from baseline to average of visit 5 and visit 6. 4. The proportion of positive outcomes (score 0 or 1) on each of the 11 questions in the Patch Sensation Questionnaire assessed at day 1 and after 2 weeks of treatment. 5. The proportion of patients with successful (>=80% of days on treatment) patch applications defined as an adhesion time >=30 minutes during the 4 weeks treatment. 6. a) Frequency and intensity of adverse events (AEs) reported during the study. 6. b) Laboratory values and vital signs. 6. c) Pseudomembranous candidiasis assessed by visual inspection. ; Timepoint(s) of evaluation of this end point: 1. a), b) and c): At the end of the 4 weeks treatment period. 2. a) and b): At the end of the 4 weeks treatment period 3. At the end of the 4 weeks treatment period. 4. After 2 weeks of treatment. 5. At the end of the 4 weeks treatment period. 6. a): Ongoing until end of the study. 6. b): At screening and at the end of study visit (visit 7) 6. c): At each visit until end of the study | — |
Countries
Canada, Denmark, Germany, Ireland, United Kingdom, United States
Contacts
Public ContactHeidi Mueller
Proinnovera GmbH
Outcome results
None listed