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 (Responsible Party):
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00610142
First received: January 24, 2008
Last updated: June 10, 2014
Last verified: June 2014
  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:


Further study details as provided by Technische Universität Dresden:

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 ]

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Technische Universität Dresden
Investigators
Principal Investigator: Roland Aschoff, MD Department of Dermatology, Medical Faculty, Technical University Dresden, Germany
  More Information

Publications:
Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT00610142     History of Changes
Other Study ID Numbers: TUD-OCT-AD-025
Study First Received: January 24, 2008
Last Updated: June 10, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität Dresden:
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 July 26, 2014