Male or female patients with a clinical diagnosis of either Discoid Lupus Erythmatosus or Systemic Lupus Erythmatosus and at least one newly developed, sharply demarcated DLE lesion. MedDRA version: 8.1 Level: LLT Classification code 10025138 Term: Lupus erythematosus discoides
Conditions
Interventions
Product Name: ASF-1096 cream 0.5%
Pharmaceutical Form: Cream
Current Sponsor code: ASF-1096
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 0.5-
Pharm
Sponsors
Astion Danmark A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 target 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare the treatment effect of ASF-1096 cream 0.5% to ASF-1096 Cream Placebo on a newly developed DLE lesion after 8 weeks of twice daily, topical treatment.;Secondary Objective: To compare the treatment effect of ASF-1096 cream 0.5% to ASF-1096 cream placebo with regard to the response/rating on/of: •Erythema •Scaling/hypertrophy •Dyspigmentation •Scarring/Atrophy/Panniculitis •Induration •Pain •Itching •Lesion area •General improvement assessed by the investigator •Global improvement assessed by the patient after 2, 4, 6 and 8 weeks of treatment. To compare and describe the safety profile in the ASF-1096 cream 0.5% and ASF-1096 cream placebo groups. ;Primary end point(s): Primary endpoint for this study is the efficacy of ASF-1096 cream 0.5% compared to the ASF-1096 cream placebo using the area under the curve (AUC) of the local CLASI score. For analysis of the primary end point the null hypothesis H0: The mean AUCs of the local CLASI score in the groups treated with ASF-1096 cream 0.5% and the ASF-1096 cream placebo are the same. will be tested versus the alternative hypothesis H1: The mean AUCs of the local CLASI score in the groups treated with ASF-1096 cream 0.5% and the ASF-1096 cream placebo are not the same. | — |
Countries
Sweden, United Kingdom
Outcome results
None listed