A phase II, single-center, randomized, controlled, double-blind study to assess effects on skin conditions and patient reported outcome of a topical formulation containing LAS41002 on lesional skin in patients with atopic eczema - AD
- Conditions
- Clinical condition of atopic eczema mild to moderate defined by a local SCORAD of at least 5 with •erythma = 2•lichenification = 1•dryness = 1 •itching = 1•Erlangen atopy score sum equal or higher than 10 pointsMedDRA version: 12.1Level: LLTClassification code 10003639Term: Atopic dermatitis
- Registration Number
- EUCTR2009-017407-28-DE
- Lead Sponsor
- Almirall Hermal GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
All of the following criteria have to be met for inclusion of a patient in the study:
• men and women aged 18 years or older;
• two comparable treament areas (difference in local SCORAD not greater than 3) on opposite extremities of 100 - 300 cm2 with at least one lesional region within each of these areas of = 20 cm². Clinical condition of atopic eczema mild to moderate defined by a local SCORAD of at least 5 with
• erythma = 2
• lichenification = 1
• dryness = 1
• itching = 1
• Erlangen atopy score sum equal or higher than 10 points (3);
• the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
• female volunteers of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices [IUDs], sexual abstinence or vasectomized partner;
• written informed consent obtained.
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
Patients are to be excluded from the study when one or more of the following conditions are met:
• acne, suntan, eczema, hyperpigmentation or tattoos in the test areas;
• dark-skinned persons whose skin color prevents ready assessment of skin reactions;
• evidence of drug or alcohol abuse;
• pregnancy or nursing;
• UV-therapy within 6 weeks before first treatment;
• 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 the treatment phase of another clinical study within the last four weeks prior to the first administration of investigational drug in this study;
• known allergic reactions to components of the study preparations, hypersensitivity against cetylstearyl alcohol;
• treatment with systemic or locally acting medications which might counter or influence the study aim (e.g. antihistamines or glucocorticosteroids) within two weeks before study day 1and throughout the study period (exception: asthma may be found in patients with atopic eczema, therefore inhalation with corticosteroids in patients with asthma accompanying atopic eczema will be allowed at a dose not exceeding 1 mg/day. The dosage should remain constant throughout the study period);
• contraindications according to summary of product characteristics;
• in the opinion of the investigator or physician performing the initial examination the patient should not participate in the study, e.g. due to probable noncompliance or inability to understand the study and give adequately informed consent;
• patient is institutionalized because of legal or regulatory order.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of the study is to evaluate the effects on clinical skin conditions and the satisfaction of customers of two different topical mometasone formulations in patients with mild to moderate atopic eczema;Secondary Objective: n.a;Primary end point(s): No primary variable is prespecified. This study evaluates the assessment of cosmetic traits and efficacy only explorativly.
- Secondary Outcome Measures
Name Time Method