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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: pimecrolimus 1% cream; Drug: hydrocortisonacetat 1% cream; Drug: Placebo; Drug: betamethasonvalerat 0,1% cream; Drug: clobetasol-17-propionat 0,05% cream

• Registration Number: NCT00655512
• Lead Sponsor: Technische Universität Dresden

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-04-04
• Study First Submitted QC: 2008-04-09
• Study First Posted: 2008-04-10
• Primary Completion: 2008-06
• Study Completion: 2008-10
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-10
• Last Update Posted: 2014-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	betamethasonvalerat 0,1% cream	-
2	clobetasol-17-propionat 0,05% cream	-
3	pimecrolimus 1% cream	-
1	hydrocortisonacetat 1% cream	-
1	betamethasonvalerat 0,1% cream	-
1	clobetasol-17-propionat 0,05% cream	-
2	pimecrolimus 1% cream	-
3	hydrocortisonacetat 1% cream	-
3	clobetasol-17-propionat 0,05% cream	-
4	pimecrolimus 1% cream	-
4	hydrocortisonacetat 1% cream	-
4	betamethasonvalerat 0,1% cream	-
5	Placebo	-

Primary Outcome Measures

Name	Time	Method
thickness of epidermis	9 times in 4 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Dermatology, Medical Faculty, TU Dresden; 🇩🇪 Dresden, Germany