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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 (OCT-AD)

This study has been completed.
Sponsor:
Information provided by:
Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT00610142
First received: January 24, 2008
Last updated: August 20, 2010
Last verified: August 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Atopic Dermatitis
 Drug: pimecrolimus 1% cream
Drug: hydrocortison 1% cream
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:
  • thickness of epidermis [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • thickness of dermis [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2007
Study Completion Date: January 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 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
Other Name: Elidel 1% cream
Active Comparator: 2 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
Other Name: Hydrogalen cream

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610142

Locations
Germany
Department of Dermatology, Medical Faculty, TU Dresden
Dresden, Germany
Sponsors and Collaborators
Dresden University of Technology
Investigators
Principal Investigator: Roland Aschoff, MD Department of Dermatology, Medical Faculty, Technical University Dresden, Germany
  More Information

No publications provided

Responsible Party: Roland Aschoff, MD, Technical University Dresden
ClinicalTrials.gov Identifier: NCT00610142     History of Changes
Other Study ID Numbers: TUD-OCT-AD-025
Study First Received: January 24, 2008
Last Updated: August 20, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:
atopic dermatitis
pimecrolimus
hydrocortison
Optical Coherence Tomography

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Pimecrolimus
Hydrocortisone
Cortisone
 Hydrocortisone-17-butyrate
Tacrolimus
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 21, 2013