Lupus erthematosus discoides 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
Pharmaceutical form of the placebo: Cream
Route of administration of the placebo: Cutaneous use
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: • 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
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: o surgically 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
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.;Primary end point(s): The primary efficacy variable is the Area under the Curve (AUC) of the local CLASI index (Cutaneous Lupus Erythematosus Disease Area and Severity Index calculated from Erythema, Scale/Hypertrophy, Dyspigmentation and Scarring/Atrophy/Panniculitis).;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: o Erythema o Scaling/Hypertrophy o Dyspigmentation o Scarring/Atrophy/Panniculitis o Induration o Pain o Itching o Lesion area o General improvement assessed by the investigator o 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. | — |
Countries
Denmark
Outcome results
None listed