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 (OCT)

June 10, 2014 updated by: Technische Universität Dresden

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dresden, Germany
        • Department of Dermatology, Medical Faculty, TU Dresden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Drug: betamethasonvalerat 0,1% cream
twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
Other Names:
  • 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 Names:
  • Clobegalen cream
Drug: pimecrolimus 1% cream
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
Other Names:
  • Elidel 1% cream
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 Names:
  • Hydrogalen cream
Drug: betamethasonvalerat 0,1% cream
twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
Other Names:
  • 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 Names:
  • Clobegalen cream
Active Comparator: 3
Drug: hydrocortisonacetat 1% cream
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
Other Names:
  • 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 Names:
  • Clobegalen cream
Drug: pimecrolimus 1% cream
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
Other Names:
  • Elidel 1% cream
Active Comparator: 4
Drug: hydrocortisonacetat 1% cream
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
Other Names:
  • Hydrogalen cream
Drug: betamethasonvalerat 0,1% cream
twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
Other Names:
  • Betagalen cream
Drug: pimecrolimus 1% cream
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
Other Names:
  • Elidel 1% cream
Placebo Comparator: 5
Drug: Placebo
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
thickness of epidermis
Time Frame: 9 times in 4 weeks
9 times in 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
atrophogenic effect assessed by dermaphot
Time Frame: 9 times in 4 weeks
9 times in 4 weeks
moisture of skin assessed by corneometer
Time Frame: 9 times in 4 weeks
9 times in 4 weeks
transpire of skin assessed by tewameter
Time Frame: 9 times in 4 weeks
9 times in 4 weeks
thickness of dermis
Time Frame: 9 times in 4 weeks
9 times in 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

April 4, 2008

First Submitted That Met QC Criteria

April 9, 2008

First Posted (Estimate)

April 10, 2008

Study Record Updates

Last Update Posted (Estimate)

June 11, 2014

Last Update Submitted That Met QC Criteria

June 10, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUD-OCT011-023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on hydrocortisonacetat 1% cream

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe