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

This study has been completed.
Sponsor:
Information provided by:
Astion Pharma A/S
ClinicalTrials.gov Identifier:
NCT00625521
First received: February 20, 2008
Last updated: February 28, 2008
Last verified: February 2008
History of Changes
  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 applied twice daily
Drug: Cream vehicle for ASF 1096 cream applied twice daily
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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

Resource links provided by NLM:

MedlinePlus related topics: Lupus
U.S. FDA Resources

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

Primary Outcome Measures:
  • Safety profile, CLASI score, GIA and GPA.

Enrollment: 32
Study Start Date: November 2006
Study Completion Date: July 2007
Arms Assigned Interventions
Experimental: 1
Drug: ASF 1096 0.5 % cream applied twice daily
 Drug: ASF 1096 0.5 % cream applied twice daily
Placebo Comparator: 2
Cream vehicle for ASF 1096 cream applied twice daily
 Drug: Cream vehicle for ASF 1096 cream applied twice daily

  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: NCT00625521

Locations
Sweden
Filippa Nyberg
Danderyd Stockholm, Sweden
Sponsors and Collaborators
Astion Pharma A/S
  More Information

No publications provided

Responsible Party: Dr. Peder M Andersen, Astion Pharma A/S
ClinicalTrials.gov Identifier: NCT00625521     History of Changes
Other Study ID Numbers: ASF1096-201
Study First Received: February 20, 2008
Last Updated: February 28, 2008
Health Authority: Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astion Pharma A/S:
Discoid lupus erythematosus

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 May 16, 2013