Cutivate Lotion HPA Axis Pediatric Study

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00546000
• Other study ID #: ALT 0434-01-01
• Status: Completed
• Phase: Phase 4
• First received: October 16, 2007
• Last updated: June 25, 2014
• Start date: July 2007
• Est. completion date: December 2008

Study information

• Verified date: June 2014
• Source: Fougera Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 12 Months

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Fluticasone propionate 0.05% lotion
Daily applications

Locations

Country	Name	City	State
United States	Dermatology Center for Children and Young Adults	Eagan	Minnesota
United States	University of Texas Medical Branch	Galveston	Texas
United States	University of Texas Health Science Center	Houston	Texas
United States	University of Miami, Dept. of Dermatology	Miami	Florida
United States	Adult & Pediatric Dermatology	Overland Park	Kansas
United States	Paddington Testing Company, Inc	Philadelphia	Pennsylvania
United States	Centre for Health Care Medical Associates	Poway	California
United States	Central Dermatology	Saint Louis	Missouri
United States	Rady Children's Hospital, San Diego	San Diego	California
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Fougera Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes