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
1 other identifier
interventional
20
1 country
1
Brief Summary
to explore the atrophogenic potentials of hydrocortison 1% cream and pimecrolimus 1% cream on unaffected forehead skin
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2007
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 24, 2008
CompletedFirst Posted
Study publicly available on registry
February 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedJune 11, 2014
June 1, 2014
8 months
January 24, 2008
June 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
thickness of epidermis
4 weeks
Secondary Outcomes (1)
thickness of dermis
4 weeks
Study Arms (2)
1
ACTIVE COMPARATOR2
ACTIVE COMPARATORInterventions
twice a day one fingertip at a 2 times 2 cm2 area of uninvolved skin on the lateral forehead for 4 weeks
twice a day one fingertip at a 2 times 2 cm2 area of uninvolved skin on the lateral forehead for 4 weeks
Eligibility Criteria
You may qualify if:
- age 18-60 years
- diagnosis of atopic dermatitis (Hanifin \& Rajka Criteria)
- patients with atopic dermatitis not affecting the forehead
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Dermatology, Medical Faculty, TU Dresden
Dresden, Germany
Related Publications (1)
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.
PMID: 21771098RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roland Aschoff, MD
Department of Dermatology, Medical Faculty, Technical University Dresden, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2008
First Posted
February 7, 2008
Study Start
December 1, 2007
Primary Completion
August 1, 2008
Study Completion
January 1, 2009
Last Updated
June 11, 2014
Record last verified: 2014-06