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

This study has been completed.
Sponsor:
Information provided by:
Astion Pharma A/S
ClinicalTrials.gov Identifier:
NCT00625157
First received: February 20, 2008
Last updated: February 28, 2008
Last verified: February 2008
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00625157

Locations
Denmark
Gregor Jemec
Roskilde Hospital, Denmark
Sponsors and Collaborators
Astion Pharma A/S
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00625157     History of Changes
Other Study ID Numbers: ASF1096-203
Study First Received: February 20, 2008
Last Updated: February 28, 2008
Health Authority: Denmark: National Board of Health

Additional relevant MeSH terms:
Lupus Erythematosus, Discoid
Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Connective Tissue Diseases
Skin Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014