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
Overview
to explore the atrophogenic potentials of hydrocortison 1% cream and pimecrolimus 1% cream on unaffected forehead skin
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Investigator)
- Study Primary Completion Date: August 2008
Interventions
- 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
- 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
Arms, Groups and Cohorts
- Active Comparator: 1
- Active Comparator: 2
Clinical Trial Outcome Measures
Primary Measures
- thickness of epidermis
- Time Frame: 4 weeks
Secondary Measures
- thickness of dermis
- Time Frame: 4 weeks
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 60 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Technische Universität Dresden
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Roland Aschoff, MD, Principal Investigator, Department of Dermatology, Medical Faculty, Technical University Dresden, Germany
Citations Reporting on Results
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.
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.