Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions (2)
Phase 2
Completed
- Conditions
- Discoid Lupus Erythematosus
- Interventions
- Drug: ASF 1096 0.5 % creamDrug: ASF 1096 placebo cream
- Registration Number
- NCT00625157
- Lead Sponsor
- Astion Pharma A/S
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 ASF 1096 0.5 % cream - 2 ASF 1096 placebo cream -
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Gregor Jemec
🇩🇰Roskilde Hospital, Denmark