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ASF-1096 Cream in Discoid Lupus Erythematosus
NCT00625521Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2006
- Countries
- 1
- Sponsor
- Astion Pharma
- Modality
- Small Molecules
- Drugs
- ASF-1096
- Conditions
- discoid lupus erythematosus (DLE)
01
Overview
Phase 2, randomised, double-blind trial in discoid lupus erythematosus (DLE) comparing ASF 1096 0.5% with Vehicle (2 arms). Primary endpoints: Safety profile, Cutaneous Lupus Erythematosus Disease Area and Severity Index and 2 more. Started Nov 2006; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
ASF 1096 0.5%
ASF 1096 0.5% cream applied twice daily
Vehicle
Vehicle cream applied twice daily
03
Who it enrols
Patients with a clinical diagnosis of DLE or SLE with newly developed discoid lesions, confirmed by biopsy. Patients with scarring at the target lesion or receiving systemic treatment for SLE are excluded.
04
Endpoints
Primary
Safety profile
Cutaneous Lupus Erythematosus Disease Area and Severity Index
Global Investigator Assessment
Global Patient Assessment
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