Short Term Growth in Children With Atopic Dermatitis

Phase 4

Completed

• Conditions: Atopic Dermatitis

• Registration Number: NCT00236106
• Lead Sponsor: Children´s Clinic, Randers

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 available

Study Timeline

• Study Start: 2005-02
• Status Verified: 2005-03
• Study Completion: 2005-06
• Study First Submitted: 2005-10-07
• Study First Submitted QC: 2005-10-07
• Study First Posted: 2005-10-12
• Last Update Submitted: 2005-12-08
• Last Update Posted: 2005-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
short term growth during treatment compared to run in

Secondary Outcome Measures

Name	Time	Method
U-EPX
U-nTX
skin prick test