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

This study has been completed.

First Received: February 20, 2008 Last Updated: February 28, 2008 History of Changes

Sponsored by:	Astion Pharma A/S
Information provided by:	Astion Pharma A/S
ClinicalTrials.gov Identifier:	NCT00625157

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 II

Study Type:	Interventional
Study Design:	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:

MedlinePlus related topics: Lupus

U.S. FDA Resources

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

Arms	Assigned Interventions
1: Experimental	Drug: ASF 1096 0.5 % cream
2: Placebo Comparator	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

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

Study placed in the following topic categories:

Cutaneous Lupus Erythematosus
Autoimmune Diseases
Skin Diseases
Lupus Erythematosus, Systemic

Lupus
Lupus Erythematosus, Cutaneous
Connective Tissue Diseases
Lupus Erythematosus, Discoid

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Skin Diseases
Lupus Erythematosus, Systemic

Lupus Erythematosus, Cutaneous
Connective Tissue Diseases
Lupus Erythematosus, Discoid

ClinicalTrials.gov processed this record on September 04, 2009