Comparison of Skin Thickness Under Treatment With Pimecrolimus 1% Cream, Hydrocortisonacetat 1% Cream, Betamethasonvalerat 0,1% Cream and Clobetasol-17-propionat 0,05% Cream Assessed by Optical Coherence Tomography (OCT) and 20-MHZ Ultrasound

Study Overview
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Brief Summary
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to compare the atrophogenic potentials of pimecrolimus 1% cream, hydrocortisonacetat 1% cream, betamethasonvalerat 0,1% cream and clobetasol-17-Propionat 0,05% cream

Official Title
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Comparison of Skin Thickness Under Treatment With Pimecrolimus 1% Cream (Elidel® 1% Cream), Hydrocortisonacetat 1% Cream (Hydrogalen® Cream), Betamethasonvalerat 0,1% Cream (Betagalen® Cream) and Clobetasol-17-propionat 0,05% Cream (Clobegalen® Cream) Assessed by Optical Coherence Tomography (OCT) and 20-MHZ Ultrasound - a Single Blind, Placebo-controlled, Randomized, Monocenter Clinical Trial

Conditions
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Healthy

Intervention / Treatment
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* Drug: pimecrolimus 1% cream
* Drug: hydrocortisonacetat 1% cream
* Drug: betamethasonvalerat 0,1% cream
* Drug: clobetasol-17-propionat 0,05% cream
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male and female probands age between 18-40 years skin healthy skintype I-III according to Fitzpatrick Exclusion Criteria: women of childbearing potential without adequate contraception pregnant or breastfeeding genetic defect of epidermal barrier external or systemic treatment with drugs, which probably have an effect to the thickness of skin or to the production of teleangiektasien within the last 6 month before study entry skin disease, which hinder the evaluation with OCT, ultrasound or dermaphot UV treatment within the last 4 weeks before study entry participation to another clinical trial within the last 30 days before study entry allergy against pimecrolimus or hydrocortison or betamethasonvalerat or Clobetasol-17-propionat severe systemic diseases; ongoing immunosuppressive treatment planned vaccination should realize before study entry or 28 days after end of treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: hydrocortisonacetat 1% cream<br>* twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks<br>* Other names: Hydrogalen cream;Drug: betamethasonvalerat 0,1% cream<br>* twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks<br>* Other names: Betagalen cream;Drug: clobetasol-17-propionat 0,05% cream<br>* twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks<br>* Other names: Clobegalen cream;|
| Active Comparator: 2<br> | Drug: pimecrolimus 1% cream<br>* twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks<br>* Other names: Elidel 1% cream;Drug: betamethasonvalerat 0,1% cream<br>* twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks<br>* Other names: Betagalen cream;Drug: clobetasol-17-propionat 0,05% cream<br>* twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks<br>* Other names: Clobegalen cream;|
| Active Comparator: 3<br> | Drug: pimecrolimus 1% cream<br>* twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks<br>* Other names: Elidel 1% cream;Drug: hydrocortisonacetat 1% cream<br>* twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks<br>* Other names: Hydrogalen cream;Drug: clobetasol-17-propionat 0,05% cream<br>* twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks<br>* Other names: Clobegalen cream;|
| Active Comparator: 4<br> | Drug: pimecrolimus 1% cream<br>* twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks<br>* Other names: Elidel 1% cream;Drug: hydrocortisonacetat 1% cream<br>* twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks<br>* Other names: Hydrogalen cream;Drug: betamethasonvalerat 0,1% cream<br>* twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks<br>* Other names: Betagalen cream;|
| Placebo Comparator: 5<br> | Drug: Placebo<br>* twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thickness of epidermis |  | 9 times in 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| atrophogenic effect assessed by dermaphot |  | 9 times in 4 weeks | 
| moisture of skin assessed by corneometer |  | 9 times in 4 weeks | 
| transpire of skin assessed by tewameter |  | 9 times in 4 weeks | 
| thickness of dermis |  | 9 times in 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pimecrolimus, hydrocortison, betamethasone, clobetasol-17-Propionat, Optical Coherence Tomography, skin healthy probands