Comparison of defined skin parameters in two comparable lesional skin areas after topical treatment with Tarenflurbil Spray or Placebo

• Conditions: Subjects with mild to moderate atopic eczema; MedDRA version: 14.0Level: LLTClassification code 10003641Term: Atopic eczemaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2011-002571-42-DE
• Lead Sponsor: GALENpharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-14
• Last Update Posted: 17 July 2012

Recruitment & Eligibility

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

Inclusion Criteria

• male or female subjects, 18 years or older;
• manifest atopic dermatitis diagnosed according to Hanifin and Rajka (3);
• two comparable lesional areas of 30 - 40 cm2 with a distance of at least 5 cm (difference in modified local SCORAD not greater than 2), clinical condition of atopic eczema mild to moderate; clinical condition of atopic eczema mild to moderate defined by a modified local SCORAD of at least 4 with
? erythema = 1
? lichenification = 1
? dryness = 1
• TEWL in the lesional areas at least 12 g/m²h, TEWL value differences = 30 % are allowed between both lesional areas (related to the higher TEWL value);
• the physical examination of the skin must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the clinical trial;
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 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• acne, suntan, eczema other than atopic eczema, hyper- or hypopigmentation or tattoos in the treatment 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 trial in the four weeks before and during the trial;
• participation in the treatment phase of another clinical trial within the last four weeks prior to the first administration of investigational drug in this clinical trial;
• known allergic reactions to components of the investigational product/s;
• treatment with systemic or locally acting medications which might counter or influence the trial aim within four weeks before the baseline visit and during the trial, e.g. antihistamines or glucocorticosteroids (exception: asthma may be found in patients with atopic dermatitis, therefore inhalation with corticosteroids in patients with asthma accompanying atopic dermatitis will be allowed);
• in the opinion of the investigator or physician performing the initial examination the subject should not participate in the clinical trial, e.g. due to probable noncompliance or inability to understand the trial and give adequately informed consent;
• close affiliation with the investigator (e.g. a close relative) or persons working at the study sites or subject is an employee of sponsor;
• subject is institutionalized because of legal or regulatory order

Study & Design

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