Short Term Growth in Children With Atopic Dermatitis - Full Text View

Sponsored by:	Children´s Clinic, Randers
Information provided by:	Children´s Clinic, Randers
ClinicalTrials.gov Identifier:	NCT00236106

Purpose

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)

Condition	Intervention	Phase
Atopic Dermatitis	Drug: tacrolimus ointment 0.1% Drug: mometasone furoate 0.1%	Phase IV

Drug Information available for: Tacrolimus Mometasone furoate Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind, Active Control, Crossover Assignment, Safety Study

Further study details as provided by Children´s Clinic, Randers:

Primary Outcome Measures:

short term growth during treatment compared to run in

Secondary Outcome Measures:

U-EPX
U-nTX
skin prick test

Estimated Enrollment:	20
Study Start Date:	February 2005
Estimated Study Completion Date:	June 2005

Eligibility

Ages Eligible for Study:	5 Years to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236106

Sponsors and Collaborators

Children´s Clinic, Randers

Investigators

Principal Investigator:

Ole Wolthers

Children's Clinic Randers

More Information

Study ID Numbers:	BKR-AD-04
Study First Received:	October 7, 2005
Last Updated:	December 8, 2005
ClinicalTrials.gov Identifier:	NCT00236106
Health Authority:	Denmark: The Regional Committee on Biomedical Research Ethics; Denmark: Danish Dataprotection Agency; Denmark: Danish Medicines Agency

Study placed in the following topic categories:

Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases
Mometasone furoate

Hypersensitivity, Immediate
Skin Diseases, Eczematous
Tacrolimus
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immune System Diseases
Therapeutic Uses
Anti-Allergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009