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Cutivate Lotion HPA Axis Pediatric Study

NCT00546000 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2014-07-24

Study results available
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Summary

A multi-center, open-label, Phase IV, unblinded study using Cutivate (fluticasone propionate, 0.05%)lotion and it's possible effects on the HPA axis of infants diagnosed with atopic dermatitis.

Conditions

Interventions

DRUG

Fluticasone propionate 0.05% lotion

Daily applications

Sponsors & Collaborators

  • Fougera Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Alan Fleischer Jr., M.D. · Wake Forest University Health Sciences

  • Lawrence F. Eichenfield, MD · Rady Children's Hospital, San Diego

  • Elizabeth Connelly, MD · University of Miami

  • Craig L. Leonardi, MD · Central Dermatology

  • Lawrence Parish, MD · Paddington Testing Company, Inc

  • Adelaide A Hebert, MD · The University of Texas Health Science Center, Houston

  • Sharon Raimer, MD · University of Texas Medical Branch, Galveston

  • Kenneth E. Bloom, MD · Dermatology Center for Children and Young Adults

  • David L Kaplan, MD · Adult & Pediatric Dermatology

  • Stephen W. Shewmake, M.D. · Centre for Health Care Medical Associates

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00546000 on ClinicalTrials.gov