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

Astion Pharma

Status and phase: Completed; Phase 2

Conditions: Discoid Lupus Erythematosus

Treatments: Drug: Cream vehicle for ASF 1096 cream applied twice daily; Drug: ASF 1096 0.5 % cream applied twice daily

Study type: Interventional

Funder types: Industry

Identifiers

NCT00625521

ASF1096-201

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Drug: ASF 1096 0.5 % cream applied twice daily

Treatment:

Drug: ASF 1096 0.5 % cream applied twice daily

2

Placebo Comparator group

Description:

Cream vehicle for ASF 1096 cream applied twice daily

Treatment:

Drug: Cream vehicle for ASF 1096 cream applied twice daily