Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions (2)

Astion Pharma A/S

Overview

Lupus Erythematosus (LE) is an autoimmune disorder that includes a broad spectrum of clinical forms. One of these forms, Discoid Lupus Erythematosus (DLE) is a chronic disfiguring disease confined to the skin. The aim of this pivotal trial is to investigate the efficacy and safety of ASF-1096 cream 0.5% in the treatment of patients with DLE or SLE presenting newly developed discoid lesions.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Discoid Lupus Erythematosus

Interventions

ASF 1096 0.5 % creamDRUG

ASF 1096 placebo creamDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A clinical diagnosis of either DLE or SLE * Histological results from biopsy confirming the diagnosis (biopsy can be taken at screening) * Is prepared to grant authorised persons access to the medical records * Has signed informed consent Exclusion Criteria: * Has an active skin disease other than DLE or another progressive or serious disease that interferes with the study outcome * Has scarring at the target lesion * Systemic treatment of SLE

Locations (1)

Gregor Jemec

Roskilde Hospital, Denmark

Data from ClinicalTrials.gov

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