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

Astion Pharma A/S32 enrolled

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Discoid Lupus Erythematosus

Interventions

ASF 1096 0.5 % cream applied twice dailyDRUG

Cream vehicle for ASF 1096 cream applied twice dailyDRUG

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)

Filippa Nyberg

Danderyd Stockholm, Sweden

Outcomes

Primary Outcomes

Safety profile, CLASI score, GIA and GPA.

Data from ClinicalTrials.gov

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