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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00625521

Enrollment

Registered

2008-02-28

Start date

2006-11-30

Completion date

2007-07-31

Last updated

2008-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Discoid Lupus Erythematosus

Keywords

Discoid lupus erythematosus

Brief 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.

Interventions

DRUGASF 1096 0.5 % cream applied twice daily

DRUGCream vehicle for ASF 1096 cream applied twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Safety profile, CLASI score, GIA and GPA.	—

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026