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NCT00236106 Clinical Trial

Short Term Growth in Children With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00236106
Other study ID # BKR-AD-04
Secondary ID
Status Completed
Phase Phase 4
First received October 7, 2005
Last updated December 8, 2005
Start date February 2005
Est. completion date June 2005

Study information
Verified date March 2005
Source Children´s Clinic, Randers
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection AgencyDenmark: Danish Medicines Agency
Study type Interventional

Clinical Trial 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)

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date June 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 5 Years to 14 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind

Related Conditions & MeSH terms

Intervention

Drug:
• tacrolimus ointment 0.1%

• mometasone furoate 0.1%

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Children´s Clinic, Randers

Outcome
Type Measure Description Time frame Safety issue
Primary short term growth during treatment compared to run in
Secondary U-EPX
Secondary U-nTX
Secondary skin prick test
See also
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