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Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions (2)

Sponsor
Astion Pharma A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT00625157
Collaborator
(none)
1
Location
2
Arms

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: ASF 1096 0.5 % cream
  • Drug: ASF 1096 placebo cream
 Phase 2

Study Design

Study Type:
Interventional
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 (2)

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: ASF 1096 0.5 % cream
Placebo Comparator: 2

Drug: ASF 1096 placebo cream

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gregor Jemec Roskilde Hospital Denmark

    Sponsors and Collaborators

    • Astion Pharma A/S

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00625157
    Other Study ID Numbers:
    • ASF1096-203
    First Posted:
    Feb 28, 2008
    Last Update Posted:
    Feb 29, 2008
    Last Verified:
    Feb 1, 2008
    Additional relevant MeSH terms:
    Lupus Erythematosus, Systemic
    Lupus Erythematosus, Discoid

    Study Results

    No Results Posted as of Feb 29, 2008