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

October 16, 2007
October 18, 2007
June 25, 2014
July 24, 2014
July 24, 2014
July 2007
December 2008   (Final data collection date for primary outcome measure)
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.
Prior and post treatment serum cortisol values will be compared. [ Time Frame: Up to 29 days of treatment ]
Complete list of historical versions of study NCT00546000 on Archive Site
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.
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 ]
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Not Provided
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.
Not Provided
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Atopic Dermatitis
Drug: Fluticasone propionate 0.05% lotion
Daily applications
Experimental: 1
Receive between 22 and 29 days of Cutivate lotion treatment
Intervention: Drug: Fluticasone propionate 0.05% lotion
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2008
December 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
3 Months to 12 Months   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
ALT 0434-01-01
Not Provided
Not Provided
Fougera Pharmaceuticals Inc.
Fougera Pharmaceuticals Inc.
Not Provided
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
Fougera Pharmaceuticals Inc.
June 2014

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