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. - Lupus study

• Conditions: Male or female patients with a clinical diagnosis of either Discoid Lupus Erythematosus or Systemic Lupus Erythematosus and at least one newly developed, sharply demarcated DLE lesion.; MedDRA version: 8.1Level: LLTClassification code 10025138Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2006-001062-17-SE
• Lead Sponsor: Astion Danmark A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

All of the following criteria have to be met for inclusion of a patient in the study:
• Patients of any gender 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 will be obtained at the beginning of the study, in case histological results confirming the diagnosis are available a new biopsy is not needed;
• The physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
• Sexually active females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should 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;
• Willing and able to comply to the study procedures;
• Prepared to grant authorised persons access to the medical records;
• 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:
• Active skin disease other then DLE or another progressive or serious disease that interferes with the study outcome;
• Scarring at the traget lesion;
• Keratonisation of treated 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);
• 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;
• Known allergic reactions to components of the study preparations;
• Pregnancy (according to pregnancy test) or nursing.

Study & Design

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