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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:
ClinicalTrials.gov Identifier:
NCT00625521
First Posted: February 28, 2008
Last Update Posted: February 29, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Astion Pharma A/S
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00625521


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

Responsible Party: Dr. Peder M Andersen, Astion Pharma A/S
ClinicalTrials.gov Identifier: NCT00625521     History of Changes
Other Study ID Numbers: ASF1096-201
First Submitted: February 20, 2008
First Posted: February 28, 2008
Last Update Posted: February 29, 2008
Last Verified: February 2008

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

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