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
  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 ]

Enrollment: 40
Study Start Date: January 2008
Study Completion Date: October 2008
Primary Completion Date: June 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Department of Dermatology, Medical Faculty, TU Dresden
Dresden, Germany
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: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT00655512     History of Changes
Other Study ID Numbers: TUD-OCT011-023
Study First Received: April 4, 2008
Last Updated: June 10, 2014
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 July 24, 2014