A single-center, randomized, controlled, observer-blind, phase IV study to develop the atopic localized eczema regression test (ALERT) using marketed topical corticosteroid formulations of different strength and the calcineurin inhibitors pimecrolimus (Elidel®) in patients with a pre-disposition for atopic dermatitis - Atopic localized eczema regression test (ALERT)

• Conditions: Patients with a pre-disposition for Atopic Dermatitis

• Registration Number: EUCTR2009-012194-35-DE
• Lead Sponsor: bioskin GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

All of the following criteria have to be met for inclusion of a patient in the study:
•Men and women aged 18 to 55 years;
•Fitzpatrick skin type II – III;
•patients demonstrating irritative skin reaction to 24 h occluded epicutaneous test
with 1 % SLS, i.e. ‘responders’;
•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;
•the dermatological examination must be without relevant disease findings (except
the criteria for the Erlangen atopy score) unless the investigator considers an
abnormality to be irrelevant to the outcome of the study;
•medical disposition for atopic dermatitis according to Erlangen atopy score sum
equal or higher than 10 points and no acute atopic dermatitis on the volar forearms
and no clinically relevant eczema on the body but otherwise no history of other
relevant dermatological or relevant systemic diseases;
•medical history of atopic dermatitis;
•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) no
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, suntan, skin infections, hyperpigmentation, or tattoos in the test fields;
•patients with negative 24 ± 2 h occluded epicutaneous test with 1 % SLS
performed prior to at bioskin or during screening;
•dark-skinned persons whose skin color prevents ready assessment of skin
reactions;
•treatment with systemic or locally acting medications which might counter or
influence the study aim within two weeks before the beginning of the study (e.g.
antihistamines or glucocorticosteroids);
•use of skin care products on the volar forearms within seven days before the ´
beginning of the induction phase;
•symptoms of a clinically significant illness that may influence the outcome of the
study in the four weeks before and during the study;
•significant UV-exposure 3 weeks prior to the start of the study including therapeutic
UV therapy and significant tanning of the volar forearm;
•participation in the treatment phase of another clinical or cosmetic study within the
last four weeks prior to induction phase;
•known allergic reactions to components of the study preparations (e.g. ´
hypersensitivity against cetylstearyl alcohol, propylene glycol, chlorocresol);
•contraindications according to summary of product characteristics; (e.g. illnesses
associated with disorder of the pituitary-adrenal axis);
•evidence of drug or alcohol abuse;
•pregnancy or nursing;
•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: ;Main Objective: The purpose of this study is to develop a regression test after repeated open washing with SLS as a model for induced eczema in patients with a pre-disposition for Atopic Dermatitis using marketed topical corticosteroid formulations of different strength as well as the calcineurin inhibitor pimecrolimus (Elidel®).;Primary end point(s): In order to conclude the induction phase and enter the regression phase the average of the TEWL values on each volar forearm must reach a mean value of 30 g/m2 h with no more than 15 g/m2 h difference between the lowest and the highest value of the three test fields per volar forearm. Only patients who meet these criteria on both arms will be randomized prior to the regression phase. <br>