Cutivate Lotion HPA Axis Pediatric Study

• ClinicalTrials.gov Identifier: NCT00546000
• Recruitment Status: Completed
• First Posted: October 18, 2007
• Results First Posted: July 24, 2014
• Last Update Posted: July 24, 2014
• Sponsor: Fougera Pharmaceuticals Inc.
• Information provided by (Responsible Party): Fougera Pharmaceuticals Inc.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Atopic Dermatitis	Drug: Fluticasone propionate 0.05% lotion	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 56 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: July 2007
• Actual Primary Completion Date: December 2008
• Actual Study Completion Date: December 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; Receive between 22 and 29 days of Cutivate lotion treatment	Drug: Fluticasone propionate 0.05% lotion; Daily applications

Outcome Measures

Primary Outcome Measures :

1. Post Treatment Serum Cortisol Values Will be Compared. [ Time Frame: Up to 29 days of treatment ]
   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 :

1. 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 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 3 Months to 12 Months (Child)
• Sexes Eligible for Study: All
• 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

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 University Health Sciences
• 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

• Responsible Party: Fougera Pharmaceuticals Inc.
• ClinicalTrials.gov Identifier: NCT00546000
• Other Study ID Numbers: ALT 0434-01-01
• First Posted: October 18, 2007
• Results First Posted: July 24, 2014
• Last Update Posted: July 24, 2014
• Last Verified: June 2014

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Fluticasone; Xhance; Anti-Inflammatory Agents; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Dermatologic Agents; Anti-Allergic Agents