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

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 (2)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00625157
Enrollment
Unknown
Registered
2008-02-28
Start date
Unknown
Completion date
Unknown
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

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
DRUGASF 1096 placebo cream

Sponsors

Astion Pharma A/S
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Countries

Denmark

Outcome results

None listed

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