MedTrace Logo

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

NCT03592342 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2020-07-14

No results posted yet for this study

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

Interventions

DRUG

Clobetasol Propionate

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

Sponsors & Collaborators

  • Proinnovera GmbH

    collaborator INDUSTRY

  • X-act Cologne Clinical Research GmbH

    collaborator INDUSTRY

  • Dermtreat

    lead INDUSTRY

Principal Investigators

  • Lars Siim Madsen, PhD · Dermtreat

  • Michael Brennan, DDS · Carolinas Healthcare System, Dept. of Oral Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-28
Primary Completion
2019-12-20
Completion
2019-12-20
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Denmark
  • Germany
  • Ireland
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03592342 on ClinicalTrials.gov