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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Technische Universität Dresden.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00655512
First received: April 4, 2008
Last updated: October 29, 2010
Last verified: October 2010
  Purpose

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


Condition Intervention Phase
Healthy
Drug: pimecrolimus 1% cream
Drug: hydrocortisonacetat 1% cream
Drug: betamethasonvalerat 0,1% cream
Drug: clobetasol-17-propionat 0,05% cream
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • thickness of epidermis [ Time Frame: 9 times in 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: January 2008
Estimated Study Completion Date: October 2008
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 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
Active Comparator: 2 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: 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
Active Comparator: 3 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: 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
Active Comparator: 4 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
Placebo Comparator: 5 Drug: Placebo
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00655512

Contacts
Contact: Roland Aschoff, MD 0049-351-458 ext 2007 Roland.Aschoff@uniklinikum-dresden.de

Locations
Germany
Department of Dermatology, Medical Faculty, TU Dresden Recruiting
Dresden, Germany
Contact: Roland Aschoff, MD    0049 351 458 ext 2007    Roland.Aschoff@uniklinikum-dresden.de   
Principal Investigator: Roland Aschoff, MD         
Sub-Investigator: Jochen Schmitt, MD         
Sponsors and Collaborators
Technische Universität Dresden
Investigators
Principal Investigator: Roland Aschoff, MD Department of Dermatology, Medical Faculty, Technical University Dresden, Germany
  More Information

No publications provided

Responsible Party: Roland Aschoff, MD, Technical University Dresden
ClinicalTrials.gov Identifier: NCT00655512     History of Changes
Other Study ID Numbers: TUD-OCT011-023
Study First Received: April 4, 2008
Last Updated: October 29, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität Dresden:
pimecrolimus
hydrocortison
betamethasone
clobetasol-17-Propionat
Optical Coherence Tomography
skin healthy probands

Additional relevant MeSH terms:
Pimecrolimus
Clobetasol
Tacrolimus
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 14, 2014