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1 Study Matches

Intra-oral Treatment of OLP With 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.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Thomas Schlieve
165506
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03592342
STU 032018-054
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Inclusion Criteria:

• OLP patients with at least one visible and measurable symptomatic ulcerative OLP lesion, assessable via OLP Clinician Reported Outcome Measure (OLPClinROM).
• 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.
Exclusion Criteria:

• 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: Corticosteroids, Antibiotics, Retinoids, Immunosuppressive drugs (e.g. azathioprine, cyclosporine, mycophenolate mofetil, or biologics), Antimycotics.
• Any of the following topical treatments used in the oral cavity prior to baseline visit: Corticosteroids, Antibiotics, Cyclosporine, Tacrolimus, Pimecrolimus, Antimycotics, Retinoids.
• 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.
• Patients who previously have failed to respond to OLP treatments with systemic glucocorticosteroids, methotrexate, cyclosporine, retinoids and/or azathioprine.
• 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. 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.
Drug: Clobetasol Propionate
Oral Lichen Planus
Patch, Rivelin-Clo Patch, Oral Lichen Planus, Ulcerative, Erythematous, OLP, OLPClinROM, OLPSSM
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