Patients with a pre-disposition for Atopic Dermatitis
Conditions
Interventions
Trade Name: Linolacort® Hydro 1.0
Product Name: Linolacort® Hydro 1.0
Pharmaceutical Form: Cream
INN or Proposed INN: Hydrocortison
CAS Number: 50-23-7
Concentration unit: % percent
Concentration ty
Sponsors
bioskin GmbH
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: •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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Outcome results
None listed