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

• Sponsor: Astion Pharma A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00625521
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Discoid Lupus Erythematosus	Drug: ASF 1096 0.5 % cream applied twice daily; Drug: Cream vehicle for ASF 1096 cream applied twice daily	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: Nov 1, 2006
• Actual Study Completion Date: Jul 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Drug: ASF 1096 0.5 % cream applied twice daily	Drug: ASF 1096 0.5 % cream applied twice daily
Placebo Comparator: 2 Cream vehicle for ASF 1096 cream applied twice daily	Drug: Cream vehicle for ASF 1096 cream applied twice daily

Outcome Measures

Primary Outcome Measures

1. Safety profile, CLASI score, GIA and GPA. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Filippa Nyberg	Danderyd Stockholm		Sweden

Sponsors and Collaborators

• Astion Pharma A/S

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00625521
• Other Study ID Numbers: ASF1096-201
• First Posted: Feb 28, 2008
• Last Update Posted: Feb 29, 2008
• Last Verified: Feb 1, 2008

• Keywords provided by , ,: Discoid lupus erythematosus
• Additional relevant MeSH terms: Lupus Erythematosus, Systemic; Lupus Erythematosus, Discoid

Study Results

No Results Posted as of Feb 29, 2008