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
Information source: Technische Universität Dresden
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atopic Dermatitis
Intervention: pimecrolimus 1% cream (Drug); hydrocortison 1% cream (Drug)
Phase: Phase 2
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
Summary
to explore the atrophogenic potentials of hydrocortison 1% cream and pimecrolimus 1% cream
on unaffected forehead skin
Clinical Details
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 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: thickness of dermis
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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
Locations and Contacts
Department of Dermatology, Medical Faculty, TU Dresden, Dresden, Germany
Additional Information
Starting date: December 2007
Last updated: June 10, 2014
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