Efficacy and safety of ASF-1096 cream 0.5 % in the treatment of patients with newly developed discoid lupus erythematosus (DLE) lesions. A multi-centre clinical phase 2, placebo controlled and double blind proof of concept study.

Phase 1

• Conditions: upus erthematosus discoides; MedDRA version: 8.1Level: LLTClassification code 10025138Term: Lupus erythematosus discoides

• Registration Number: EUCTR2006-003780-30-DK
• Lead Sponsor: Astion Danmark A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-15
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

All of the following criteria have to be met for inclusion of a patient in the study:
•Male or female patients aged from 18 to 70 years
•A clinical diagnosis of either DLE or SLE
•At least one newly developed, sharply demarcated DLE lesion (target lesion) with erythema score > 1 and scaling score >1
•Histological results from biopsy confirming the diagnosis (biopsy can be taken at screening)
•No clinically relevant abnormalities at physical examination
•Is willing and able to comply to the study procedures
•Is prepared to grant authorised persons access to the medical records
•Has signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will not be included in the study when one or more of the following conditions are met:
•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
•Has keratonisation of the target lesion
•Concomitant (or within four weeks prior to dosing) treatment with corticosteroids (local or systemic), anti-malarials, retinoids or thalidomide
•Systemic treatment of SLE
•Concomitant (or within four weeks prior to dosing) treatment with medicinal products containing salbutamol (local or systemic)
•Has symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study
•Participation in another clinical trial, including the four week period preceding the study
•Has known allergic reactions to components of the study preparations
•Is pregnant (according to pregnancy test) or nursing
•Females of childbearing potential who do not fulfil one of the following criteria:
osurgically sterile (hysterectomy or tubal ligation)
o use a medically accepted contraceptive regimen for at least 12 weeks prior to the study, during the study and one month after the end of the study: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intrauterine device (IUD), condom with intravaginal spermicide

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified