Clinical Trials Logo
  1. Home
  2. Discoid Lupus Erythematosus
  3. NCT00625157
  4. Details
NCT00625157 Clinical Trial

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

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 (2)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00625157
Other study ID # ASF1096-203
Secondary ID
Status Completed
Phase Phase 2
First received February 20, 2008
Last updated February 28, 2008

Study information
Verified date February 2008
Source Astion Pharma A/S
Contact n/a
Is FDA regulated No
Health authority Denmark: National Board of Health
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 0
Est. completion date
Est. primary completion date
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

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ASF 1096 0.5 % cream

• ASF 1096 placebo cream

Locations
Country Name City State
Denmark Gregor Jemec Roskilde Hospital

Sponsors (1)
Lead Sponsor Collaborator
Astion Pharma A/S

Country where clinical trial is conducted

Denmark, 

See also
  Status Clinical Trial Phase
Withdrawn NCT03866317 - A Study to Assess the Safety and Efficacy of Secukinumab in Alleviating Symptoms of Discoid Lupus Erythematosus Phase 2
Completed NCT00001680 - A Pilot Trial of Topical Thalidomide for the Management of Chronic Discoid Lupus Erythematosus Phase 2
Recruiting NCT05591222 - Study of Daxdilimab (HZN-7734) in Patients With Moderate-to-Severe Primary Discoid Lupus Erythematosus Phase 2
Completed NCT00625521 - Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions Phase 2
Completed NCT04908280 - Study of Ruxolitinib Cream for the Treatment of Discoid Lupus Erythematosus Phase 2
Completed NCT02125695 - Pilot Tape Harvesting Study N/A
Completed NCT05362188 - Topical Nicotinamide in Treatment of DLE Early Phase 1
Completed NCT00708916 - Safety Study of Clinical and Immune Effects of Phosphodiesterase 4 (PDE-4) Inhibitor in Cutaneous Lupus Patients Phase 1/Phase 2
Terminated NCT03958955 - Efficacy and Safety of Delgocitinib Cream in Discoid Lupus Erythematosus. Phase 2
Terminated NCT03159936 - Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Early Phase 1
Completed NCT00691769 - Expression of Fas Protein in Skin Biopsies of Participants With Scarring Alopecia
Completed NCT00608673 - Comparing the Therapeutic Efficacy of Pimecrolimus Cream With Betamethasone Cream for Discoid Lupus Erythematosus N/A
Recruiting NCT06261021 - Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects With Discoid Lupus Erythematosus Phase 2