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OpenTrials
Completed

NCT Number: NCT00236106

Short Term Growth in Children With Atopic Dermatitis

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)

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

5 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus Ointment 0.1%

Drug

mometasone furoate 0.1%

Drug

Primary outcomes

  1. short term growth during treatment compared to run in

Secondary outcomes

  1. U-EPX

  2. U-nTX

  3. skin prick test

Sponsors and collaborators

Lead sponsor

Children´s Clinic, Randers

Other

Registry information

Important dates

Study start
2005
Study completion
2005
First posted
Oct 12, 2005
Registry last updated
Dec 9, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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