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