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

Verified by: Dresden University of Technology, August 2010
First Received: January 24, 2008 | Last Updated: August 20, 2010 | Phase: Phase 2 | Start Date: December 2007
Overall Status: Completed | Estimated Enrollment: 20
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to explore the atrophogenic potentials of hydrocortison 1% cream and pimecrolimus 1% cream on unaffected forehead...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
  • 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

Outcome Measures for this Clinical Trial

Primary Measures

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

Secondary Measures

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

Criteria for Participation 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 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

Clinical Trial Investigator Information

Lead Investigator: Dresden University of Technology Other

Overall Clinical Trial Officials and Contacts

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

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00610142