Back to resultsEfficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions (2)
Primary Purpose
Discoid Lupus Erythematosus
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
ASF 1096 0.5 % cream
ASF 1096 placebo cream
Sponsored by
About this trial
This is an interventional treatment trial for Discoid Lupus Erythematosus
Eligibility Criteria
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
Sites / Locations
- Gregor Jemec
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00625157
Brief Title
Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions (2)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Astion Pharma A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Discoid Lupus Erythematosus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ASF 1096 0.5 % cream
Intervention Type
Drug
Intervention Name(s)
ASF 1096 placebo cream
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Gregor Jemec
City
Roskilde Hospital
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions (2)
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