Short Term Growth in Children With Atopic Dermatitis
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ClinicalTrials.gov Identifier: NCT00236106 |
Recruitment Status
:
Completed
First Posted
: October 12, 2005
Last Update Posted
: December 9, 2005
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Sponsor:
Children´s Clinic, Randers
Information provided by:
Children´s Clinic, Randers
Tracking Information | ||||
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First Submitted Date ICMJE | October 7, 2005 | |||
First Posted Date ICMJE | October 12, 2005 | |||
Last Update Posted Date | December 9, 2005 | |||
Study Start Date ICMJE | February 2005 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE |
short term growth during treatment compared to run in | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00236106 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Short Term Growth in Children With Atopic Dermatitis | |||
Official Title ICMJE | Not Provided | |||
Brief Summary | Main objective:to assess short term growth in children with atopic dermatitis during treatment with tacrolimus 0.1% and mometasone furoate 0.1%. A singl blind randomised cross over trial including 20 children. The study consists of 5 periods: run in, treatment(1),wash out, treatment(2) and run out. Each period 14 days where the children will use tacrolimus ointment tvice daily, mometasone furoate once daily or moisturizer (in run in wash out and run out) | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single |
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Condition ICMJE | Atopic Dermatitis | |||
Intervention ICMJE |
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Study Arms | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE |
20 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date | June 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria: age 5-14, atopic dermatitis, normal current growth, Tanner 1, informed consent by the parent or guardian, willing and able to comply with study procedures Exclusion Criteria: Tanner 2-5, treatment of atopic dermatitis with anti-inflammatory agent within 1 week before the first visit, current asthma or rhinoconjunctivitis that requires treatment with glucocorticoids, endocrine diseases, major surgery within 4 weeks prior to visit 1, fever >39.5 for >3 days |
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Sex/Gender |
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Ages | 5 Years to 14 Years (Child) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00236106 | |||
Other Study ID Numbers ICMJE | BKR-AD-04 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Children´s Clinic, Randers | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Children´s Clinic, Randers | |||
Verification Date | March 2005 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |