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Sponsored by: |
Astion Pharma A/S |
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Information provided by: | Astion Pharma A/S |
ClinicalTrials.gov Identifier: | NCT00625157 |
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.
Condition | Intervention | Phase |
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Discoid Lupus Erythematosus |
Drug: ASF 1096 0.5 % cream Drug: ASF 1096 placebo cream |
Phase II |
Study Type: | Interventional |
Study Design: | 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 (2) |
Arms | Assigned Interventions |
---|---|
1: Experimental | Drug: ASF 1096 0.5 % cream |
2: Placebo Comparator | Drug: ASF 1096 placebo cream |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | ASF1096-203 |
Study First Received: | February 20, 2008 |
Last Updated: | February 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00625157 |
Health Authority: | Denmark: National Board of Health |
Autoimmune Diseases Skin Diseases Lupus Erythematosus, Systemic Lupus Erythematosus, Cutaneous |
Connective Tissue Diseases Lupus Erythematosus, Discoid Cutaneous lupus erythematosus |
Immune System Diseases |