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
Information source: Dresden University of Technology
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: pimecrolimus 1% cream (Drug); hydrocortisonacetat 1% cream (Drug); betamethasonvalerat 0,1% cream (Drug); clobetasol-17-propionat 0,05% cream (Drug); Placebo (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Dresden University of Technology Official(s) and/or principal investigator(s):
Roland Aschoff, MD, Principal Investigator, Affiliation: Department of Dermatology, Medical Faculty, Technical University Dresden, Germany
Overall contact:
Roland Aschoff, MD, Phone: 0049-351-458, Ext: 2007, Email: Roland.Aschoff@uniklinikum-dresden.de
Summary
to compare the atrophogenic potentials of pimecrolimus 1% cream, hydrocortisonacetat 1%
cream, betamethasonvalerat 0,1% cream and clobetasol-17-Propionat 0,05% cream
Clinical Details
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
Study design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety Study
Primary outcome: thickness of epidermis
Secondary outcome: atrophogenic effect assessed by dermaphotmoisture of skin assessed by corneometer transpire of skin assessed by tewameter thickness of dermis
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Both.
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
Locations and Contacts
Roland Aschoff, MD, Phone: 0049-351-458, Ext: 2007, Email: Roland.Aschoff@uniklinikum-dresden.de
Department of Dermatology, Medical Faculty, TU Dresden, Dresden, Germany; Recruiting
Roland Aschoff, MD, Phone: 0049 351 458, Ext: 2007, Email: Roland.Aschoff@uniklinikum-dresden.de
Roland Aschoff, MD, Principal Investigator
Jochen Schmitt, MD, Sub-Investigator
Additional Information
Starting date: January 2008
Ending date: October 2008
Last updated: April 9, 2008
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