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Cutivate Lotion HPA Axis Pediatric Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fougera Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00546000
First received: October 16, 2007
Last updated: June 25, 2014
Last verified: June 2014
  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 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


Further study details as provided by Fougera Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Post Treatment Serum Cortisol Values Will be Compared. [ Time Frame: Up to 29 days of treatment ] [ Designated as safety issue: Yes ]
    The primary safety parameter was the response to the CST at the end of treatment/final visit. Blood samples were collected prior to injection of cosyntropin and post-injection. Post-CST stimulation cortisol level ≤ 18micrograms/dL was considered as evidence of adrenal suppression.


Secondary Outcome Measures:
  • Record 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 ]
    The frequency distributions of the presence/absence of adverse events associated with signs of atrophy and pigmentation changes were summarized with frequency counts. Hematology and Chemistry Assessments were summarized in shift tables. Signs and symptoms of AD were summarized at each visit.


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
Experimental: 1
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Centre for Health Care Medical Associates
Poway, California, United States, 92064
Rady Children's Hospital, San Diego
San Diego, California, United States, 92123
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 Medical Branch
Galveston, Texas, United States, 77555-0783
University of Texas Health Science Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Fougera Pharmaceuticals Inc.
Investigators
Principal Investigator: Alan Fleischer Jr., M.D. Wake Forest School of Medicine
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: Fougera Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00546000     History of Changes
Other Study ID Numbers: ALT 0434-01-01
Study First Received: October 16, 2007
Results First Received: June 25, 2014
Last Updated: June 25, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Fluticasone
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014