Cutivate Lotion HPA Axis Pediatric Study

Completed · Phase 4

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT00546000

Run by

Fougera Pharmaceuticals Inc.

People needed

56

Starts

2007-07-01

Expected to finish

2008-12-01

Last updated by the study team

2014-07-24

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Centre for Health Care Medical Associates — Poway, California, United States
• Rady Children's Hospital, San Diego — San Diego, California, United States
• University of Miami, Dept. of Dermatology — Miami, Florida, United States
• Adult & Pediatric Dermatology — Overland Park, Kansas, United States
• Dermatology Center for Children and Young Adults — Eagan, Minnesota, United States
• Central Dermatology — St Louis, Missouri, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Paddington Testing Company, Inc — Philadelphia, Pennsylvania, United States
• University of Texas Medical Branch — Galveston, Texas, United States
• University of Texas Health Science Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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