Comparison of Atrophogenic Effect of Hydrocortison 1% Cream and Pimecrolimus 1% Cream Assessed by Optical Coherence Tomography (OCT) and 20-MHz Ultrasound of Uninvolved Skin in Patients With Atopic Dermatitis (OCT-AD)

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ClinicalTrials.gov Identifier: NCT00610142

Recruitment Status : Completed

First Posted : February 7, 2008

Last Update Posted : June 11, 2014

Sponsor:

Information provided by (Responsible Party):

Technische Universität Dresden

Study Description

Brief Summary:

to explore the atrophogenic potentials of hydrocortison 1% cream and pimecrolimus 1% cream on unaffected forehead skin

Condition or disease	Intervention/treatment	Phase
Atopic Dermatitis	Drug: pimecrolimus 1% cream Drug: hydrocortison 1% cream	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	20 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Investigator)
Primary Purpose:	Treatment
Official Title:	Comparison of Atrophogenic Effect of Hydrocortison 1% Cream and Pimecrolimus 1% Cream Assessed by Optical Coherence Tomography (OCT) and 20-MHz Ultrasound of Uninvolved Skin in Patients With Atopic Dermatitis
Study Start Date :	December 2007
Actual Primary Completion Date :	August 2008
Actual Study Completion Date :	January 2009

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Atopic dermatitis

MedlinePlus related topics: Eczema

Drug Information available for: Hydrocortisone acetate Hydrocortisone Hydrocortisone sodium succinate Hydrocortisone cypionate Hydrocortisone valerate Hydrocortisone probutate Proctofoam-HC Pimecrolimus

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1	Drug: pimecrolimus 1% cream twice a day one fingertip at a 2 times 2 cm2 area of uninvolved skin on the lateral forehead for 4 weeks Other Name: Elidel 1% cream
Active Comparator: 2	Drug: hydrocortison 1% cream twice a day one fingertip at a 2 times 2 cm2 area of uninvolved skin on the lateral forehead for 4 weeks Other Name: Hydrogalen cream

Outcome Measures

Primary Outcome Measures :

thickness of epidermis [ Time Frame: 4 weeks ]

Secondary Outcome Measures :

thickness of dermis [ Time Frame: 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

age 18-60 years
diagnosis of atopic dermatitis (Hanifin & Rajka Criteria)
patients with atopic dermatitis not affecting the forehead

Exclusion Criteria:

pregnancy / nursing mothers
women in reproductive age without adequate contraception
severe atopic dermatitis (IGA >= 4)
UV-Therapy in past 4 weeks
patients receiving any topical treatment on the face in past 6 month

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00610142

Locations

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

Sponsors and Collaborators

Technische Universität Dresden

Investigators

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Principal Investigator:	Roland Aschoff, MD	Department of Dermatology, Medical Faculty, Technical University Dresden, Germany

More Information

Publications of Results:

Aschoff R, Schmitt J, Knuschke P, Koch E, Bräutigam M, Meurer M. Evaluation of the atrophogenic potential of hydrocortisone 1% cream and pimecrolimus 1% cream in uninvolved forehead skin of patients with atopic dermatitis using optical coherence tomography. Exp Dermatol. 2011 Oct;20(10):832-6. doi: 10.1111/j.1600-0625.2011.01335.x. Epub 2011 Jul 19.

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Responsible Party:	Technische Universität Dresden
ClinicalTrials.gov Identifier:	NCT00610142
Other Study ID Numbers:	TUD-OCT-AD-025
First Posted:	February 7, 2008 Key Record Dates
Last Update Posted:	June 11, 2014
Last Verified:	June 2014

Keywords provided by Technische Universität Dresden:


atopic dermatitis pimecrolimus hydrocortison Optical Coherence Tomography

Additional relevant MeSH terms:

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Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Hydrocortisone Pimecrolimus Anti-Inflammatory Agents	Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antirheumatic Agents Dermatologic Agents Immunosuppressive Agents Immunologic Factors Calcineurin Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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