Short Term Growth in Children With Atopic Dermatitis

This study has been completed.

Sponsor:

Information provided by:

Children´s Clinic, Randers

ClinicalTrials.gov Identifier:

NCT00236106

First received: October 7, 2005

Last updated: December 8, 2005

Last verified: March 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

October 7, 2005

Last Updated Date

December 8, 2005

Start Date ^ICMJE

February 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

short term growth during treatment compared to run in

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00236106 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

U-EPX
U-nTX
skin prick test

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Short Term Growth in Children With Atopic Dermatitis

Official Title ^ICMJE

Not Provided

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind

Condition ^ICMJE

Atopic Dermatitis

Intervention ^ICMJE

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

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Estimated Completion Date

June 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

5 Years to 14 Years (Child)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00236106

Other Study ID Numbers ^ICMJE

BKR-AD-04

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Children´s Clinic, Randers

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ole Wolthers

Children's Clinic Randers

PRS Account

Children´s Clinic, Randers

Verification Date

March 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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