Intra-oral Treatment of OLP With Rivelin®-CLO Patches

Completed · Phase 2 · Has a placebo group

Conditions studied: Oral Lichen Planus

In brief

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.

Key facts

Study ID

NCT03592342

Run by

Dermtreat

People needed

140

Starts

2018-06-28

Expected to finish

2019-12-20

Last updated by the study team

2020-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• 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.

Where it is running

• 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
• Texas A&M University (TAMU), College of Dentistry — Dallas, Texas, United States
• UT Southwestern Medical Center Department of Surgery — Dallas, Texas, United States
• ENT Associates of Texas — Frisco, Texas, United States
• The Oral and Facial Surgery Center — Clearfield, Utah, United States
• Kaye Edmonton Clinic — Edmonton, Alberta, Canada
• Health Sciences North, North East Cancer Center — Greater Sudbury, Ontario, Canada
• Rigshospitalet — Copenhagen, Denmark
• University of Copenhagen Department of Odontology — Copenhagen, Denmark
• LMU München, Klinik und Poliklinik für Dermatologie und Allergologie — Munich, Germany
• Cork University Dental School and Hospital — Cork, Ireland
• School of Dental Sciences Newcastel Upon Tyne — Newcastle upon Tyne, Newcastel, United Kingdom
• Edinburgh Dental Institute — Edinburgh, United Kingdom
• University of Glasgow Dental School — Glasgow, United Kingdom
• Leeds Dental Institute — Leeds, United Kingdom
• King´s College London Dental Institute, Oral Clinical Research Unit — London, United Kingdom

Full record on ClinicalTrials.gov

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