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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Filippa Nyberg

Danderyd Stockholm, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASF 1096 0.5 % cream applied twice daily

Drug

Cream vehicle for ASF 1096 cream applied twice daily

Drug

Primary outcomes

Safety profile, CLASI score, GIA and GPA.

Sponsors and collaborators

Lead sponsor

Astion Pharma A/S

Industry

Registry information

Official study 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

Important dates

Study start: 2006
Study completion: 2007
First posted: Feb 28, 2008
Registry last updated: Feb 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed