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COMPLETEDPhase 4NCT00546000

Cutivate Lotion HPA Axis Pediatric Study

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.

Lead sponsor: Fougera Pharmaceuticals Inc.•10 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Fougera Pharmaceuticals Inc.

Age

0 - 1 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Subjects are 3-12 months of age
•Subjects diagnosed with Atopic Dermatitis (AD) and have ≥35% of Body Surface Area
•Subjects meet protocol specific AD signs and symptom severity score

Exclusion Criteria

•Subjects with conditions effecting the HPA Axis
•Subjects with clinically significant systemic disease
•Subjects who require treatment with systemic or topical retinoids during the study
•Subjects who have been treated with various chronic therapies identified in the protocol
•Subjects who have received other investigational drug treatment within 30 days prior to study entry

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 24, 2014Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE4

Enrollment56

Start dateJul 2007

Last updatedJul 24, 2014

Condition

Atopic Dermatitis

Locations shown

Centre for Health Care Medical Associates

Poway, California

Rady Children's Hospital, San Diego

San Diego, California

University of Miami, Dept. of Dermatology

Miami, Florida

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 24, 2014Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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