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

NCT03592342 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: DT-001-R-004
• Study Type: interventional
• Target: 140
• Locations: 6 countries
• Sites: 27

Brief 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.

Conditions

Oral Lichen Planus

Keywords

Patch; Rivelin-Clo Patch; Oral Lichen Planus; Ulcerative; Erythematous; OLP; OLPClinROM; OLPSSM

Outcome Measures

Primary Outcomes (1)

• Change in ulcer area

  The change will be calculated from baseline to end of trial

  4 weeks

Secondary Outcomes (9)

• Change in lesion area

  4 weeks

• Change in 5-point erythema score

  4 weeks

• Change in Clinical global impression score

  4 weeks

• Change in OLPSSM total score (item #1 to #7)

  4 weeks

• Change in individual diary symptom scores (item #1 to #7 of the OLPSSM)

  4 weeks

Study Arms (4)

Rivelin® plain patches

PLACEBO COMPARATOR

Dosing is two times per day (morning and evening) with Rivelin® plain patches (placebo).

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.

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.

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.

Drug: Clobetasol Propionate

Interventions

Clobetasol Propionate DRUG

Rivelin® patch is a two-layer patch comprised of a muco-adhesive, drug-delivery layer and a protective layer.

Rivelin® plain patches; Rivelin®-CLO patch 1µg; Rivelin®-CLO patch 20µg; Rivelin®-CLO patch 5µg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Dermtreat: lead
• Proinnovera GmbH: collaborator
• X-act Cologne Clinical Research GmbH: collaborator

Study Sites (27)

QWay Research

Hialeah, Florida, 33010, United States

Location

Vitae Research Center, LLC

Miami, Florida, 33135, United States

Location

Valencia Medical & Research Center

Miami, Florida, 33165, United States

Location

The Dental College of Georgia

Augusta, Georgia, 30912, United States

Location

Tufts University, School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

Brigham and Women's Hospital, Division of Oral Medicine and Dentistry

Boston, Massachusetts, 02115, United States

Location

NYU College of Dentistry, Bluestone Center for Clinical Research

New York, New York, 10010, United States

Location

UNC Dermatology and Skin Cancer Center

Chapel Hill, North Carolina, 27516, United States

Location

Carolinas Center for Oral Health

Charlotte, North Carolina, 28209, United States

Location

University of Pennsylvania Health System, Dept. Oral amd Maxillofacial Surgery

Philadelphia, Pennsylvania, 19104, United States

Location

Texas A&M University (TAMU), College of Dentistry

Dallas, Texas, 75246, United States

Location

UT Southwestern Medical Center Department of Surgery

Dallas, Texas, 75390-9109, United States

Location

ENT Associates of Texas

Frisco, Texas, 75035, United States

Location

The Oral and Facial Surgery Center

Clearfield, Utah, 84105, United States

Location

Kaye Edmonton Clinic

Edmonton, Alberta, T6G1Z1, Canada

Location

Health Sciences North, North East Cancer Center

Greater Sudbury, Ontario, P3E5JL, Canada

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

University of Copenhagen Department of Odontology

Copenhagen, 2100, Denmark

Location

LMU München, Klinik und Poliklinik für Dermatologie und Allergologie

Munich, 80337, Germany

Location

Cork University Dental School and Hospital

Cork, T12 E8YV, Ireland

Location

School of Dental Sciences Newcastel Upon Tyne

Newcastle upon Tyne, Newcastel, NE2 4BW, United Kingdom

Location

Edinburgh Dental Institute

Edinburgh, EH3 9HA, United Kingdom

Location

University of Glasgow Dental School

Glasgow, G2 3JZ, United Kingdom

Location

Leeds Dental Institute

Leeds, LS9 9LU, United Kingdom

Location

King´s College London Dental Institute, Oral Clinical Research Unit

London, SE1 9RT, United Kingdom

Location

University College London and University College London Hospitals Trust

London, WC1X 8LD, United Kingdom

Location

University of Sheffield, School of Clinical Dentistry

Sheffield, S10 2TA, United Kingdom

Location

MeSH Terms

Conditions

Lichen Planus, Oral; Ulcer

Interventions

Clobetasol

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Lars Siim Madsen, PhD

  Dermtreat

  STUDY CHAIR

• Michael Brennan, DDS

  Carolinas Healthcare System, Dept. of Oral Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All 4 interventions will be similar in appearance and be allocated by use of a blinded kit number (each kit contains drug for 1 week).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: July 19, 2018
• Study Start: June 28, 2018
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: July 14, 2020

Record last verified: 2020-07

Locations

IE (1); US (14); GB (7); CA (2); DK (2); DE (1)