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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)

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ClinicalTrials.gov Identifier: NCT00610142
Recruitment Status : Completed
First Posted : February 7, 2008
Last Update Posted : June 11, 2014
Sponsor:
Information provided by (Responsible Party):
Technische Universität Dresden

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

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: pimecrolimus 1% cream Drug: hydrocortison 1% cream Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : December 2007
Primary Completion Date : August 2008
Study Completion Date : January 2009


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. thickness of epidermis [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. thickness of dermis [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT00610142     History of Changes
Other Study ID Numbers: TUD-OCT-AD-025
First Posted: February 7, 2008    Key Record Dates
Last Update Posted: June 11, 2014
Last Verified: June 2014

Keywords provided by Technische Universität Dresden:
atopic dermatitis
pimecrolimus
hydrocortison
Optical Coherence Tomography

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