Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Astion Pharma A/S
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