Conditions: Lupus Erythematosus, Discoid Lupus Erythematosus, Systemic
Keywords: Discoid Lupus Erythematosus Systemic Lupus Erythematosus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 54
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the safety, efficacy and tolerability of topical R333 ointment in Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) patients with active discoid lesions.

Detailed description:
This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the preliminary efficacy, safety, tolerability, and pharmacokinetics of topical R333 ointment formulated at 6% (60 mg/g) in DLE and SLE patients with active discoid lesions.

Arms:
arm 1: R333 6% (60 mg/g), bid arm 2: Placebo, bid

Interventions: intervention 1: R932333 intervention 2: Placebo
Intervention descriptions: intervention 1: R393233 6% (60 mg/g), bid intervention 2: Placebo, bid

Protocol document: