Official Title: “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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety Study

Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

• 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 in this Clinical Trial

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

Primary Measures

• thickness of epidermis
  • Time Frame: 9 times in 4 weeks
    Safety Issue?: No

Secondary Measures

• atrophogenic effect assessed by dermaphot
  • Time Frame: 9 times in 4 weeks
    Safety Issue?: No
• moisture of skin assessed by corneometer
  • Time Frame: 9 times in 4 weeks
    Safety Issue?: No
• transpire of skin assessed by tewameter
  • Time Frame: 9 times in 4 weeks
    Safety Issue?: No
• thickness of dermis
  • Time Frame: 9 times in 4 weeks
    Safety Issue?: No

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 for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Dresden University of Technology

Overall Clinical Trial Officials and Contacts

Roland Aschoff, MD Principal Investigator Department of Dermatology, Medical Faculty, Technical University Dresden, Germany  

Overall Contact: Roland Aschoff, MD 0049-351-458 Roland.Aschoff@uniklinikum-dresden.de

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00655512

Study ID Number: TUD-OCT011-023

ClinicalTrials.gov Identifier: NCT00655512

Health Authority: Germany: Federal Institute for Drugs and Medical Devices