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Cutivate Lotion HPA Axis Pediatric Study

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fluticasone propionate 0.05% lotion
Sponsored by
Fougera Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

3 Months - 12 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre for Health Care Medical Associates
  • Rady Children's Hospital, San Diego
  • University of Miami, Dept. of Dermatology
  • Adult & Pediatric Dermatology
  • Dermatology Center for Children and Young Adults
  • Central Dermatology
  • Wake Forest University Health Sciences
  • Paddington Testing Company, Inc
  • University of Texas Medical Branch
  • University of Texas Health Science Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Receive between 22 and 29 days of Cutivate lotion treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 16, 2007
Last Updated
June 25, 2014
Sponsor
Fougera Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00546000
Brief Title
Cutivate Lotion HPA Axis Pediatric Study
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 Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fougera Pharmaceuticals Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Receive between 22 and 29 days of Cutivate lotion treatment
Intervention Type
Drug
Intervention Name(s)
Fluticasone propionate 0.05% lotion
Intervention Description
Daily applications
Primary Outcome Measure Information:
Title
Post Treatment Serum Cortisol Values Will be Compared.
Description
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.
Time Frame
Up to 29 days of treatment
Secondary Outcome Measure Information:
Title
Record Skin Atrophy, Pigmentation Change, Hematological and Chemistry Assessments, and Changes in Atopic Dermatitis Severity
Description
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.
Time Frame
Over 5-6 visits following the baseline visit through the end of treatment between Day 22-29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Fleischer Jr., M.D.
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lawrence F. Eichenfield, MD
Organizational Affiliation
Rady Children's Hospital, San Diego
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elizabeth Connelly, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Craig L. Leonardi, MD
Organizational Affiliation
Central Dermatology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lawrence Parish, MD
Organizational Affiliation
Paddington Testing Company, Inc
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adelaide A Hebert, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sharon Raimer, MD
Organizational Affiliation
University of Texas Medical Branch, Galveston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenneth E. Bloom, MD
Organizational Affiliation
Dermatology Center for Children and Young Adults
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David L Kaplan, MD
Organizational Affiliation
Adult & Pediatric Dermatology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen W. Shewmake, M.D.
Organizational Affiliation
Centre for Health Care Medical Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Health Care Medical Associates
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Rady Children's Hospital, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of Miami, Dept. of Dermatology
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Adult & Pediatric Dermatology
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Dermatology Center for Children and Young Adults
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55121-1176
Country
United States
Facility Name
Central Dermatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Paddington Testing Company, Inc
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0783
Country
United States
Facility Name
University of Texas Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Cutivate Lotion HPA Axis Pediatric Study

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