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 - Full Text View

Sponsored by:	Dresden University of Technology
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00655512

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 I

MedlinePlus related topics: Ultrasound

Drug Information available for: Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC Betamethasone Bentelan Betamethasone dipropionate Pimecrolimus Clobetasol Clobetasol propionate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety Study
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

Further study details as provided by Dresden University of Technology:

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
1: Active Comparator	Drug: hydrocortisonacetat 1% cream twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks Drug: betamethasonvalerat 0,1% cream twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks Drug: clobetasol-17-propionat 0,05% cream twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
2: Active Comparator	Drug: pimecrolimus 1% cream twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks Drug: betamethasonvalerat 0,1% cream twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks Drug: clobetasol-17-propionat 0,05% cream twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
3: Active Comparator	Drug: pimecrolimus 1% cream twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks Drug: hydrocortisonacetat 1% cream twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks Drug: clobetasol-17-propionat 0,05% cream twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
4: Active Comparator	Drug: pimecrolimus 1% cream twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks Drug: hydrocortisonacetat 1% cream twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks Drug: betamethasonvalerat 0,1% cream twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
5: Placebo Comparator	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

Dresden University of Technology

Investigators

Principal Investigator:

Roland Aschoff, MD

Department of Dermatology, Medical Faculty, Technical University Dresden, Germany

More Information

Responsible Party:	Technical University Dresden ( Roland Aschoff, MD )
Study ID Numbers:	TUD-OCT011-023
Study First Received:	April 4, 2008
Last Updated:	April 9, 2008
ClinicalTrials.gov Identifier:	NCT00655512
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:

pimecrolimus
hydrocortison
betamethasone

clobetasol-17-Propionat
Optical Coherence Tomography
skin healthy probands

Study placed in the following topic categories:

Clobetasol
Betamethasone-17,21-dipropionate
Hydrocortisone
Cortisol succinate
Betamethasone sodium phosphate

Pimecrolimus
Tacrolimus
Hydrocortisone acetate
Healthy
Betamethasone

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Glucocorticoids
Hormones
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 16, 2009