Back to resultsComparison 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)
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
pimecrolimus 1% cream
hydrocortison 1% cream
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring atopic dermatitis, pimecrolimus, hydrocortison, Optical Coherence Tomography
Eligibility 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
Sites / Locations
- Department of Dermatology, Medical Faculty, TU Dresden
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
thickness of epidermis
Secondary Outcome Measures
thickness of dermis
Full Information
NCT ID
NCT00610142
First Posted
January 24, 2008
Last Updated
June 10, 2014
Sponsor
Technische Universität Dresden
1. Study Identification
Unique Protocol Identification Number
NCT00610142
Brief 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
Acronym
OCT-AD
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 Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technische Universität Dresden
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
to explore the atrophogenic potentials of hydrocortison 1% cream and pimecrolimus 1% cream on unaffected forehead skin
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
atopic dermatitis, pimecrolimus, hydrocortison, Optical Coherence Tomography
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
pimecrolimus 1% cream
Other Intervention Name(s)
Elidel 1% cream
Intervention Description
twice a day one fingertip at a 2 times 2 cm2 area of uninvolved skin on the lateral forehead for 4 weeks
Intervention Type
Drug
Intervention Name(s)
hydrocortison 1% cream
Other Intervention Name(s)
Hydrogalen cream
Intervention Description
twice a day one fingertip at a 2 times 2 cm2 area of uninvolved skin on the lateral forehead for 4 weeks
Primary Outcome Measure Information:
Title
thickness of epidermis
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
thickness of dermis
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland Aschoff, MD
Organizational Affiliation
Department of Dermatology, Medical Faculty, Technical University Dresden, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology, Medical Faculty, TU Dresden
City
Dresden
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
21771098
Citation
Aschoff R, Schmitt J, Knuschke P, Koch E, Brautigam M, Meurer M. Evaluation of the atrophogenic potential of hydrocortisone 1% cream and pimecrolimus 1% cream in uninvolved forehead skin of patients with atopic dermatitis using optical coherence tomography. Exp Dermatol. 2011 Oct;20(10):832-6. doi: 10.1111/j.1600-0625.2011.01335.x. Epub 2011 Jul 19.
Results Reference
result
Learn more about this trial
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
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