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

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astion Pharma A/S

Criteria

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