Clinical trial NCT00546000: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Lead sponsor: Fougera Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2007-10-18
Enrollment: 56
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Post Treatment Serum Cortisol Values Will be Compared.
timeFrame: Up to 29 days of treatment
Secondary outcomes:
measure: Record Skin Atrophy, Pigmentation Change, Hematological and Chemistry Assessments, and Changes in Atopic Dermatitis Severity
timeFrame: Over 5-6 visits following the baseline visit through the end of treatment between Day 22-29
Other outcomes:
Locations:
city: Poway
country: United States
facility: Centre for Health Care Medical Associates
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital, San Diego
state: California
city: Miami
country: United States
facility: University of Miami, Dept. of Dermatology
state: Florida
city: Overland Park
country: United States
facility: Adult & Pediatric Dermatology
state: Kansas
city: Eagan
country: United States
facility: Dermatology Center for Children and Young Adults
state: Minnesota
city: Saint Louis
country: United States
facility: Central Dermatology
state: Missouri
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Philadelphia
country: United States
facility: Paddington Testing Company, Inc
state: Pennsylvania
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
Study officials:
affiliation: Wake Forest University Health Sciences
name: Alan Fleischer Jr., M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rady Children's Hospital, San Diego
name: Lawrence F. Eichenfield, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Elizabeth Connelly, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Dermatology
name: Craig L. Leonardi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Paddington Testing Company, Inc
name: Lawrence Parish, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Adelaide A Hebert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Medical Branch, Galveston
name: Sharon Raimer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Center for Children and Young Adults
name: Kenneth E. Bloom, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Adult & Pediatric Dermatology
name: David L Kaplan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Health Care Medical Associates
name: Stephen W. Shewmake, M.D.
role: PRINCIPAL_INVESTIGATOR
References: