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
NCT ID: NCT00655512
Last Updated: 2014-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2008-01-31
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
hydrocortisonacetat 1% cream
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
betamethasonvalerat 0,1% cream
twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
clobetasol-17-propionat 0,05% cream
twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
2
pimecrolimus 1% cream
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
betamethasonvalerat 0,1% cream
twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
clobetasol-17-propionat 0,05% cream
twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
3
pimecrolimus 1% cream
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
hydrocortisonacetat 1% cream
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
clobetasol-17-propionat 0,05% cream
twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
4
pimecrolimus 1% cream
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
hydrocortisonacetat 1% cream
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
betamethasonvalerat 0,1% cream
twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
5
Placebo
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
Interventions
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pimecrolimus 1% cream
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
hydrocortisonacetat 1% cream
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
betamethasonvalerat 0,1% cream
twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
clobetasol-17-propionat 0,05% cream
twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
Placebo
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* skin healthy
* skintype I-III according to Fitzpatrick
Exclusion Criteria
* 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
18 Years
40 Years
ALL
Yes
Sponsors
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Technische Universität Dresden
OTHER
Responsible Party
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Principal Investigators
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Roland Aschoff, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Dermatology, Medical Faculty, Technical University Dresden, Germany
Locations
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Department of Dermatology, Medical Faculty, TU Dresden
Dresden, , Germany
Countries
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Other Identifiers
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TUD-OCT011-023
Identifier Type: -
Identifier Source: org_study_id
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