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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00655512
First received: April 4, 2008
Last updated: June 10, 2014
Last verified: June 2014

April 4, 2008
June 10, 2014
January 2008
June 2008   (final data collection date for primary outcome measure)
thickness of epidermis [ Time Frame: 9 times in 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00655512 on ClinicalTrials.gov Archive Site
  • atrophogenic effect assessed by dermaphot [ Time Frame: 9 times in 4 weeks ] [ Designated as safety issue: No ]
  • moisture of skin assessed by corneometer [ Time Frame: 9 times in 4 weeks ] [ Designated as safety issue: No ]
  • transpire of skin assessed by tewameter [ Time Frame: 9 times in 4 weeks ] [ Designated as safety issue: No ]
  • thickness of dermis [ Time Frame: 9 times in 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Healthy
  • Drug: pimecrolimus 1% cream
    twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
    Other Name: Elidel 1% cream
  • Drug: hydrocortisonacetat 1% cream
    twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
    Other Name: Hydrogalen cream
  • Drug: betamethasonvalerat 0,1% cream
    twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
    Other Name: Betagalen cream
  • Drug: clobetasol-17-propionat 0,05% cream
    twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
    Other Name: Clobegalen cream
  • Drug: Placebo
    twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
  • Active Comparator: 1
    Interventions:
    • Drug: hydrocortisonacetat 1% cream
    • Drug: betamethasonvalerat 0,1% cream
    • Drug: clobetasol-17-propionat 0,05% cream
  • Active Comparator: 2
    Interventions:
    • Drug: pimecrolimus 1% cream
    • Drug: betamethasonvalerat 0,1% cream
    • Drug: clobetasol-17-propionat 0,05% cream
  • Active Comparator: 3
    Interventions:
    • Drug: pimecrolimus 1% cream
    • Drug: hydrocortisonacetat 1% cream
    • Drug: clobetasol-17-propionat 0,05% cream
  • Active Comparator: 4
    Interventions:
    • Drug: pimecrolimus 1% cream
    • Drug: hydrocortisonacetat 1% cream
    • Drug: betamethasonvalerat 0,1% cream
  • Placebo Comparator: 5
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
October 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00655512
TUD-OCT011-023
No
Technische Universität Dresden
Technische Universität Dresden
Not Provided
Principal Investigator: Roland Aschoff, MD Department of Dermatology, Medical Faculty, Technical University Dresden, Germany
Technische Universität Dresden
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP