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Completed

NCT Number: NCT00655512

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

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

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Dermatology, Medical Faculty, TU Dresden

Dresden, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pimecrolimus 1% cream

Drug

twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks

Other names: Elidel 1% cream

hydrocortisonacetat 1% cream

Drug

twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks

Other names: Hydrogalen cream

betamethasonvalerat 0,1% cream

Drug

twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks

Other names: Betagalen cream

clobetasol-17-propionat 0,05% cream

Drug

twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks

Other names: Clobegalen cream

Placebo

Drug

twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks

Primary outcomes

  1. thickness of epidermis

    Time frame: 9 times in 4 weeks

Secondary outcomes

  1. atrophogenic effect assessed by dermaphot

    Time frame: 9 times in 4 weeks

  2. moisture of skin assessed by corneometer

    Time frame: 9 times in 4 weeks

  3. transpire of skin assessed by tewameter

    Time frame: 9 times in 4 weeks

  4. thickness of dermis

    Time frame: 9 times in 4 weeks

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study 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

Acronym: OCT

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 10, 2008
Registry last updated
Jun 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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