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

Discoid Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00625521
• Other study ID #: ASF1096-201
• Status: Completed
• Phase: Phase 2
• First received: February 20, 2008
• Last updated: February 28, 2008
• Start date: November 2006
• Est. completion date: July 2007

Study information

• Verified date: February 2008
• Source: Astion Pharma A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Discoid Lupus Erythematosus
• Lupus Erythematosus, Discoid
• Lupus Erythematosus, Systemic

Intervention

Drug:
• ASF 1096 0.5 % cream applied twice daily

• Cream vehicle for ASF 1096 cream applied twice daily

Locations

Country	Name	City	State
Sweden	Filippa Nyberg	Danderyd Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Astion Pharma A/S

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety profile, CLASI score, GIA and GPA.