Cutivate Lotion HPA Axis Pediatric Study
Information source: Therapeutics, Inc.
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atopic Dermatitis
Intervention: Fluticasone propionate 0.05% lotion (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Therapeutics, Inc. Official(s) and/or principal investigator(s):
Alan Fleischer Jr., M.D., Principal Investigator, Affiliation: Wake Forest University
Lawrence F. Eichenfield, MD, Principal Investigator, Affiliation: Rady Children's Hospital, San Diego
Elizabeth Connelly, MD, Principal Investigator, Affiliation: University of Miami
Craig L. Leonardi, MD, Principal Investigator, Affiliation: Central Dermatology
Lawrence Parish, MD, Principal Investigator, Affiliation: Paddington Testing Company, Inc
Adelaide A Hebert, MD, Principal Investigator, Affiliation: The University of Texas Health Science Center, Houston
Sharon Raimer, MD, Principal Investigator, Affiliation: University of Texas Medical Branch, Galveston
Kenneth E. Bloom, MD, Principal Investigator, Affiliation: Dermatology Center for Children and Young Adults
David L Kaplan, MD, Principal Investigator, Affiliation: Adult & Pediatric Dermatology
Stephen W. Shewmake, M.D., Principal Investigator, Affiliation: Centre for Health Care Medical Associates
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.
Clinical Details
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 design: Treatment, Open Label, Single Group Assignment
Primary outcome: Prior and post treatment serum cortisol values will be compared.
Secondary outcome: Record adverse events, skin atrophy, pigmentation change, hematological and chemistry assessments, and changes in atopic dermatitis severity
Eligibility
Minimum age: 3 Months.
Maximum age: 12 Months.
Gender(s): Both.
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
Locations and Contacts
Rady Children's Hospital, San Diego, San Diego, California 92123, United States; Recruiting
Nicola Borok, RN, CCRC, Phone: 858-576-1700, Ext: 4295
Lawrence F. Eichenfield, MD, Principal Investigator
Centre for Health Care Medical Associates, Poway, California 92064, United States; Recruiting
Lynn Sartori, Phone: 858-675-3145
Stephen W. Shewmake, MD, Principal Investigator
University of Miami, Dept. of Dermatology, Miami, Florida 33125, United States; Recruiting
Carol Kittles, Phone: 305-243-8485
Elizabeth Connelly, MD, Principal Investigator
Adult & Pediatric Dermatology, Overland Park, Kansas 66211, United States; Recruiting
Regina Robinson, Phone: 913-469-1115, Ext: 250
David L Kaplan, MD, Principal Investigator
Dermatology Center for Children and Young Adults, Eagan, Minnesota 55121-1176, United States; Recruiting
Dawn Larson, Phone: 651-379-9999
Kenneth E Bloom, MD, Principal Investigator
Central Dermatology, Saint Louis, Missouri 63117, United States; Recruiting
Linda Daus, R.N., Phone: 314-721-5565
Craig L. Leonardi, MD, Principal Investigator
Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States; Recruiting
Robin Inabinet, Phone: 336-713-4116, Email: rinabine@wfubmc.edu
Alan Fleischer, Jr., M.D., Principal Investigator
Paddington Testing Company, Inc, Philadelphia, Pennsylvania 19103, United States; Recruiting
Hirak B. Routh, MBBS, Phone: 215-563-7330
Lawrence Parish, MD, Principal Investigator
University of Texas Health Science Center, Houston, Texas 77030, United States; Recruiting
Maria D Lopez, Phone: 713-500-8266
Adelaide A Hebert, MD, Principal Investigator
University of Texas Medical Branch, Galveston, Texas 77555-0783, United States; Recruiting
Judy A. Conner, CCRC, Phone: 409-772-7209
Sharon Raimer, MD, Principal Investigator
Additional Information
Starting date: July 2007
Ending date: August 2008
Last updated: July 14, 2008
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