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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: Technische Universität Dresden
ClinicalTrials.gov processed this data on August 23, 2015
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: Completed

Sponsored by: Technische Universität Dresden

Official(s) and/or principal investigator(s):
Roland Aschoff, MD, Principal Investigator, Affiliation: Department of Dermatology, Medical Faculty, Technical University Dresden, Germany


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

Primary outcome: thickness of epidermis

Secondary outcome:

atrophogenic effect assessed by dermaphot

moisture of skin assessed by corneometer

transpire of skin assessed by tewameter

thickness of dermis


Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Both.


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


- severe systemic diseases; ongoing immunosuppressive treatment

- planned vaccination should realize before study entry or 28 days after end of


Locations and Contacts

Department of Dermatology, Medical Faculty, TU Dresden, Dresden, Germany
Additional Information

Starting date: January 2008
Last updated: June 10, 2014

Page last updated: August 23, 2015

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