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.

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