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

This study has been completed.
Information provided by:
Astion Pharma A/S Identifier:
First received: February 20, 2008
Last updated: February 28, 2008
Last verified: February 2008

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
Discoid Lupus Erythematosus Drug: ASF 1096 0.5 % cream Drug: ASF 1096 placebo cream Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:

Further study details as provided by Astion Pharma A/S:

Arms Assigned Interventions
Experimental: 1 Drug: ASF 1096 0.5 % cream
Placebo Comparator: 2 Drug: ASF 1096 placebo cream


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00625157

Gregor Jemec
Roskilde Hospital, Denmark
Sponsors and Collaborators
Astion Pharma A/S
  More Information Identifier: NCT00625157     History of Changes
Other Study ID Numbers: ASF1096-203
Study First Received: February 20, 2008
Last Updated: February 28, 2008

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Lupus Erythematosus, Discoid
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Lupus Erythematosus, Cutaneous
Skin Diseases processed this record on June 23, 2017