Cutivate Lotion HPA Axis Pediatric Study

Phase 4

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Fluticasone propionate 0.05% lotion

• Registration Number: NCT00546000
• Lead Sponsor: Fougera Pharmaceuticals Inc.

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 available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-10-16
• Study First Submitted QC: 2007-10-16
• Study First Posted: 2007-10-18
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2014-06
• Results First Submitted: 2014-06-25
• Results First Submitted QC: 2014-06-25
• Last Update Submitted: 2014-06-25
• Results First Posted: 2014-07-24
• Last Update Posted: 2014-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Fluticasone propionate 0.05% lotion	Receive between 22 and 29 days of Cutivate lotion treatment

Primary Outcome Measures

Name	Time	Method
Post Treatment Serum Cortisol Values Will be Compared.	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.

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (10)

Centre for Health Care Medical Associates; 🇺🇸 Poway, California, United States

University of Miami, Dept. of Dermatology; 🇺🇸 Miami, Florida, United States

Dermatology Center for Children and Young Adults; 🇺🇸 Eagan, Minnesota, United States

Paddington Testing Company, Inc; 🇺🇸 Philadelphia, Pennsylvania, United States

Central Dermatology; 🇺🇸 Saint Louis, Missouri, United States

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States

University of Texas Health Science Center; 🇺🇸 Houston, Texas, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States

Adult & Pediatric Dermatology; 🇺🇸 Overland Park, Kansas, United States

Rady Children's Hospital, San Diego; 🇺🇸 San Diego, California, United States