Assessment of the effects on barrier impairment, clinical features and bacterial colonization of topical formulations in patients with atopic eczema; a phase IIa, single-center, randomized, observer-blind study

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

All of the following criteria have to be met for inclusion of a patient in the study:
• signed written informed consent obtained;
• male or female patients, 18 years or older;
• manifest atopic eczema diagnosed according to Hanifin and Rajka;
• two comparable lesional areas of 20 - 50 cm2 with a distance of at least 5 cm, clinical condition of atopic eczema mild to moderate (meeting Hanifin and Rajka´s criteria);
• TEWL in the lesional areas at least 12 g/m²h, TEWL value differences = 30 % are allowed between both lesional areas;
• 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: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intrauterine device (IUD), condom with intravaginal spermicide.

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 are to be excluded from the study when one or more of the following conditions are met:
• acne, eczema other than atopic eczema, hyper- or hypopigmentation or tattoos in the treatment areas;
• suntan which in the opinion of the investigator prevents correct assessments
• 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;
• participation in another clinical study involving pharmaceutical products in the 28 days preceding or during the study;
• symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
• known allergic reactions to components of the study preparation and the comparator;
• treatment with systemic or locally acting medications which might counter or influence the study aim (e.g. antihistamines or glucocorticosteroids) within two weeks before the beginning of the study (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);
• 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
Secondary Objective: ;Primary end point(s): Efficacy variables: <br>• TEWL values measured on study days 1, 8, 15, 22, and 29<br>• clinical assessment of erythema, edema/infiltrate, excoriations, papules on study days 1, 8, 15, 22, and 29<br>• corneometric values measured on study days 1, 8, 15, 22, and 29<br>• bacterial counts of Staphylococcus aureus on study days 1 and 29<br>;Main Objective: The purpose of this study is the assessment of the barrier impairment (TEWL measurements), clinical skin condition (corneometric measurements and clinical assessments) and bacterial colonization of Staphylococcus aureus status in patients with atopic eczema following topical treatment with K201 cream and the comparator Jellin® Basis Creme over a 4-week treatment period.

Secondary Outcome Measures