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

Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Patients With Newly Developed Discoid Lupus Erythematosus (DLE) Lesions. An International Multi-Centre Clinical Phase 2, Placebo Controlled and Double Blind Proof of Concept Study

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.

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