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

NCT ID: NCT00610142

Last Updated: 2014-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-01-31

Brief Summary

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

Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Group Type ACTIVE_COMPARATOR

pimecrolimus 1% cream

Intervention Type DRUG

twice a day one fingertip at a 2 times 2 cm2 area of uninvolved skin on the lateral forehead for 4 weeks

2

Group Type ACTIVE_COMPARATOR

hydrocortison 1% cream

Intervention Type DRUG

twice a day one fingertip at a 2 times 2 cm2 area of uninvolved skin on the lateral forehead for 4 weeks

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Elidel 1% cream Hydrogalen cream

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roland Aschoff, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Department of Dermatology, Medical Faculty, TU Dresden

Dresden, , Germany

Site Status

Countries

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Germany

References

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Aschoff R, Schmitt J, Knuschke P, Koch E, Brautigam 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.

Reference Type RESULT
PMID: 21771098 (View on PubMed)

Other Identifiers

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TUD-OCT-AD-025

Identifier Type: -

Identifier Source: org_study_id

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