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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: June 2008

Interventions

  • Drug: pimecrolimus 1% cream
    • twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
  • Drug: hydrocortisonacetat 1% cream
    • twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
  • Drug: betamethasonvalerat 0,1% cream
    • twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
  • Drug: clobetasol-17-propionat 0,05% cream
    • twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
  • Drug: Placebo
    • twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks

Arms, Groups and Cohorts

  • Active Comparator: 1
  • Active Comparator: 2
  • Active Comparator: 3
  • Active Comparator: 4
  • Placebo Comparator: 5

Clinical Trial Outcome Measures

Primary Measures

  • thickness of epidermis
    • Time Frame: 9 times in 4 weeks

Secondary Measures

  • atrophogenic effect assessed by dermaphot
    • Time Frame: 9 times in 4 weeks
  • moisture of skin assessed by corneometer
    • Time Frame: 9 times in 4 weeks
  • transpire of skin assessed by tewameter
    • Time Frame: 9 times in 4 weeks
  • thickness of dermis
    • Time Frame: 9 times in 4 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Technische Universität Dresden
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Roland Aschoff, MD, Principal Investigator, Department of Dermatology, Medical Faculty, Technical University Dresden, Germany

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