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 - Full Text View

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)

This study has been completed.

First Received on January 24, 2008. Last Updated on August 20, 2010 History of Changes

Sponsor:	Dresden University of Technology
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00610142

Purpose

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

Condition	Intervention	Phase
Atopic Dermatitis	Drug: pimecrolimus 1% cream Drug: hydrocortison 1% cream	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Ultrasound

Drug Information available for: Hydrocortisone acetate Hydrocortisone Proctofoam-HC Hydrocortisone hemisuccinate Hydrocortamate Pimecrolimus Hydrocortisone 21-sodium succinate Hydrocortisone cypionate Cortisol succinate Cortisol 21-phosphate

U.S. FDA Resources

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:

thickness of epidermis [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

thickness of dermis [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	December 2007
Study Completion Date:	January 2009
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610142

Locations

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

Sponsors and Collaborators

Dresden University of Technology

Investigators

Principal Investigator:

Roland Aschoff, MD

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

More Information

No publications provided

Responsible Party:	Roland Aschoff, MD, Technical University Dresden
ClinicalTrials.gov Identifier:	NCT00610142 History of Changes
Other Study ID Numbers:	TUD-OCT-AD-025
Study First Received:	January 24, 2008
Last Updated:	August 20, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:

atopic dermatitis
pimecrolimus
hydrocortison
Optical Coherence Tomography

Additional relevant MeSH terms:

Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cortisol succinate
Hydrocortisone acetate
Pimecrolimus
Hydrocortisone
Cortisone
Tacrolimus

Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
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
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012