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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014