Trial intelligence / Profile preview

Rivelin-CLO Patches in Oral Lichen Planus

NCT03592342Phase 2

Key facts

Status: Completed
Start: Jun 2018
Primary completion: Dec 2019
Countries: 6
Sponsor: AFYX Therapeutics
Modality: Small Molecules

Drugs: clobetasol
Conditions: oral lichen planus (OLP)

Overview

Phase 2, randomised, double-blind trial of clobetasol in oral lichen planus (OLP) (4 arms), sponsored by AFYX Therapeutics. Primary endpoint: Change in ulcer area at 4 weeks. Started Jun 2018; status: completed.

Design

4 arms

Study design: RandomizedDouble-blind

Placebo
Rivelin plain patch
1 μg Clobetasol
Rivelin-CLO 1 μg/patch
5 μg Clobetasol
Rivelin-CLO 5 μg/patch
20 μg Clobetasol
Rivelin-CLO 20 μg/patch

Who it enrols

Adult patients with histologically confirmed Oral Lichen Planus and at least one visible symptomatic ulcerative lesion, excluding those with active infections, recent oral surgery, or requiring >6 patches.

Endpoints

Primary

Change in ulcer area4 weeks

Secondary

Change in lesion area4 weeks
Change in 5-point erythema score4 weeks
Change in Clinical Global Impression score4 weeks
Change in OLPSSM total score4 weeks
Change in individual diary symptom scores4 weeks
Proportion of patients with successful patch applications4 weeks
Incidence of Treatment-Emergent Adverse Events4 weeks

Results

Primary endpoints met

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