Cutivate Lotion HPA Axis Pediatric Study

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

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Fluticasone propionate 0.05% lotion

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Treatment Serum Cortisol Values Will be Compared.	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.	Up to 29 days of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Record Skin Atrophy, Pigmentation Change, Hematological and Chemistry Assessments, and Changes in Atopic Dermatitis Severity	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.	Over 5-6 visits following the baseline visit through the end of treatment between Day 22-29

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: October 16, 2007
• First Submitted That Met QC Criteria: October 16, 2007
• First Posted (Estimate): October 18, 2007

Study Record Updates

• Last Update Posted (Estimate): July 24, 2014
• Last Update Submitted That Met QC Criteria: June 25, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Fluticasone; Xhance
• Other Study ID Numbers: ALT 0434-01-01