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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety Study

Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

• 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 in this Clinical Trial

• Active Comparator: 1
• Active Comparator: 2

Primary Measures

• thickness of epidermis
  • Time Frame: 4 weeks
    Safety Issue?: No

Secondary Measures

• thickness of dermis
  • Time Frame: 4 weeks
    Safety Issue?: No

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 for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Dresden University of Technology

Overall Clinical Trial Officials and Contacts

Roland Aschoff, MD Principal Investigator Department of Dermatology, Medical Faculty, Technical University Dresden, Germany  

Overall Contact: Roland Aschoff, MD 0049-351-458 Roland.Aschoff@uniklinikum-dresden.de

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00610142

Study ID Number: TUD-OCT-AD-025

ClinicalTrials.gov Identifier: NCT00610142

Health Authority: Germany: Federal Institute for Drugs and Medical Devices