Cutivate Lotion HPA Axis Pediatric Study - Full Text View

Sponsor:	Therapeutics, Inc.
Collaborator:	Nycomed US Inc.
Information provided by:	Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00546000

Purpose

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.

Condition	Intervention	Phase
Atopic Dermatitis	Drug: Fluticasone propionate 0.05% lotion	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	A Multi-Center, Open-Label Study to Evaluate the Effect of ALTANA Inc's Cutivate (Fluticasone Propionate) Lotion 0.05% on the Hypothalmic Pituitary Adrenal (HPA) Axis in the Treatment of Atopic Dermatitis in a Pediatric Population

Resource links provided by NLM:

Drug Information available for: Fluticasone propionate Fluticasone

U.S. FDA Resources

Further study details as provided by Therapeutics, Inc.:

Primary Outcome Measures:

Prior and post treatment serum cortisol values will be compared. [ Time Frame: Up to 29 days of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Record adverse events, skin atrophy, pigmentation change, hematological and chemistry assessments, and changes in atopic dermatitis severity [ Time Frame: Over 5-6 visits following the baseline visit through the end of treatment between Day 22-29 ] [ Designated as safety issue: Yes ]

Enrollment:	56
Study Start Date:	July 2007
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Receive between 22 and 29 days of Cutivate lotion treatment	Drug: Fluticasone propionate 0.05% lotion Daily applications

Eligibility

Ages Eligible for Study:	3 Months to 12 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546000

Locations

United States, California
Rady Children's Hospital, San Diego
San Diego, California, United States, 92123
Centre for Health Care Medical Associates
Poway, California, United States, 92064
United States, Florida
University of Miami, Dept. of Dermatology
Miami, Florida, United States, 33125
United States, Kansas
Adult & Pediatric Dermatology
Overland Park, Kansas, United States, 66211
United States, Minnesota
Dermatology Center for Children and Young Adults
Eagan, Minnesota, United States, 55121-1176
United States, Missouri
Central Dermatology
Saint Louis, Missouri, United States, 63117
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
Paddington Testing Company, Inc
Philadelphia, Pennsylvania, United States, 19103
United States, Texas
University of Texas Health Science Center
Houston, Texas, United States, 77030
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0783

Sponsors and Collaborators

Therapeutics, Inc.

Nycomed US Inc.

Investigators

Principal Investigator:	Alan Fleischer Jr., M.D.	Wake Forest University
Principal Investigator:	Lawrence F. Eichenfield, MD	Rady Children's Hospital, San Diego
Principal Investigator:	Elizabeth Connelly, MD	University of Miami
Principal Investigator:	Craig L. Leonardi, MD	Central Dermatology
Principal Investigator:	Lawrence Parish, MD	Paddington Testing Company, Inc
Principal Investigator:	Adelaide A Hebert, MD	The University of Texas Health Science Center, Houston
Principal Investigator:	Sharon Raimer, MD	University of Texas Medical Branch, Galveston
Principal Investigator:	Kenneth E. Bloom, MD	Dermatology Center for Children and Young Adults
Principal Investigator:	David L Kaplan, MD	Adult & Pediatric Dermatology
Principal Investigator:	Stephen W. Shewmake, M.D.	Centre for Health Care Medical Associates

More Information

No publications provided

Responsible Party:	Manager, Clinical Research Operations ( Kathleen Ocasio )
Study ID Numbers:	ALT 0434-01-01
Study First Received:	October 16, 2007
Last Updated:	December 8, 2008
ClinicalTrials.gov Identifier:	NCT00546000 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Dermatitis, Atopic
Skin Diseases
Immune System Diseases
Physiological Effects of Drugs
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions
Hypersensitivity
Genetic Diseases, Inborn

Autonomic Agents
Therapeutic Uses
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Fluticasone
Peripheral Nervous System Agents
Dermatologic Agents
Skin Diseases, Genetic
Bronchodilator Agents
Dermatitis

ClinicalTrials.gov processed this record on February 08, 2010