Trial | NCT00625521  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    asf 1096 ...

  • Study Participants

    32
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.
Study Started
Nov 30
2006
Study Completion
Jul 31
2007
Last Update
Feb 29
2008
Estimate

Drug ASF 1096 0.5 % cream applied twice daily

Drug Cream vehicle for ASF 1096 cream applied twice daily

1 Experimental

Drug: ASF 1096 0.5 % cream applied twice daily

2 Placebo Comparator

Cream vehicle for ASF 1096 cream applied twice daily

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
No Results Posted