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

Sponsored by:	Astion Pharma A/S
Information provided by:	Astion Pharma A/S
ClinicalTrials.gov Identifier:	NCT00625521

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 II

MedlinePlus related topics: Lupus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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
1: Experimental Drug: ASF 1096 0.5 % cream applied twice daily	Drug: ASF 1096 0.5 % cream applied twice daily
2: Placebo Comparator 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

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

Keywords provided by Astion Pharma A/S:

Discoid lupus erythematosus

Study placed in the following topic categories:

Autoimmune Diseases
Skin Diseases
Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous

Connective Tissue Diseases
Lupus Erythematosus, Discoid
Cutaneous lupus erythematosus

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009