Short Term Growth in Children With Atopic Dermatitis

Tracking Information
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; (submitted: October 7, 2005)	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; (submitted: October 7, 2005)	U-EPX; U-nTX; skin prick test
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
Condition ICMJE	Atopic Dermatitis
Intervention ICMJE	Drug: tacrolimus ointment 0.1%; Drug: mometasone furoate 0.1%
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.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: October 7, 2005)	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
Sex/Gender	Sexes Eligible for Study: All
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	Principal Investigator: Ole Wolthers Children's Clinic Randers
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