Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions
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.
|Discoid Lupus Erythematosus||Drug: ASF 1096 0.5 % cream applied twice daily Drug: Cream vehicle for ASF 1096 cream applied twice daily||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- Safety profile, CLASI score, GIA and GPA.
|Study Start Date:||November 2006|
|Study Completion Date:||July 2007|
Drug: ASF 1096 0.5 % cream applied twice daily
|Drug: ASF 1096 0.5 % cream applied twice daily|
Placebo Comparator: 2
Cream vehicle for ASF 1096 cream applied twice daily
|Drug: Cream vehicle for ASF 1096 cream applied twice daily|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00625521
|Danderyd Stockholm, Sweden|