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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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

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

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Mometasone furoate
Tacrolimus
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013