Short Term Growth in Children With Atopic Dermatitis

Children´s Clinic, Randers

Status and phase: Completed; Phase 4

Conditions: Atopic Dermatitis

Treatments: Drug: tacrolimus ointment 0.1%; Drug: mometasone furoate 0.1%

Study type: Interventional

Funder types: Other

Identifiers

NCT00236106

BKR-AD-04

Details and patient eligibility

About

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)

Sex: All

Ages: 5 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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