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
1 other identifier
interventional
56
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2007
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 16, 2007
CompletedFirst Posted
Study publicly available on registry
October 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
July 24, 2014
CompletedJuly 24, 2014
June 1, 2014
1.4 years
October 16, 2007
June 25, 2014
June 25, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Record Skin Atrophy, Pigmentation Change, Hematological and Chemistry Assessments, and Changes in Atopic Dermatitis Severity
Over 5-6 visits following the baseline visit through the end of treatment between Day 22-29
Study Arms (1)
1
EXPERIMENTALReceive between 22 and 29 days of Cutivate lotion treatment
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Centre for Health Care Medical Associates
Poway, California, 92064, United States
Rady Children's Hospital, San Diego
San Diego, California, 92123, United States
University of Miami, Dept. of Dermatology
Miami, Florida, 33125, United States
Adult & Pediatric Dermatology
Overland Park, Kansas, 66211, United States
Dermatology Center for Children and Young Adults
Eagan, Minnesota, 55121-1176, United States
Central Dermatology
St Louis, Missouri, 63117, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Paddington Testing Company, Inc
Philadelphia, Pennsylvania, 19103, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0783, United States
University of Texas Health Science Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Angela C. Kaplan
- Organization
- Fougera Pharmaceuticals Inc.
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2007
First Posted
October 18, 2007
Study Start
July 1, 2007
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
July 24, 2014
Results First Posted
July 24, 2014
Record last verified: 2014-06