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Cutivate Lotion HPA Axis Pediatric Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Fougera Pharmaceuticals Inc.

Tracking Information
First Submitted Date  ICMJE October 16, 2007
First Posted Date  ICMJE October 18, 2007
Results First Submitted Date  ICMJE June 25, 2014
Results First Posted Date  ICMJE July 24, 2014
Last Update Posted Date July 24, 2014
Study Start Date  ICMJE July 2007
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 16, 2007)
Prior and post treatment serum cortisol values will be compared. [ Time Frame: Up to 29 days of treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2014)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2007)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cutivate Lotion HPA Axis Pediatric Study
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE Drug: Fluticasone propionate 0.05% lotion
Daily applications
Study Arms  ICMJE Experimental: 1
Receive between 22 and 29 days of Cutivate lotion treatment
Intervention: Drug: Fluticasone propionate 0.05% lotion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2008)
56
Original Estimated Enrollment  ICMJE
 (submitted: October 16, 2007)
55
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months to 12 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00546000
Other Study ID Numbers  ICMJE ALT 0434-01-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fougera Pharmaceuticals Inc.
Study Sponsor  ICMJE Fougera Pharmaceuticals Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Fougera Pharmaceuticals Inc.
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP