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ISRCTN
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ISRCTN71227633
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ClinicalTrials.gov identifier
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Public title
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An Open-Label Adrenal Suppression Study of Fluocinonide 0.1% Cream in Pediatric Subjects with Atopic Dermatitis
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Scientific title
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Acronym
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N/A
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Serial number at source
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MP-0201-07
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Study hypothesis
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The primary objective of the study was to evaluate the potential of fluocinonide 0.1% cream to suppress the hypothalamic-pituitary-adrenal (HPA) axis, when applied once daily or twice daily for 14 days by pediatric subjects with atopic dermatitis
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Ethics approval
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Approved by the Essex Institutional Review Board, Inc. on 23/06/2004
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Study design
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Multicenter, multiple-dose, open-label study with four sequential age cohorts
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Countries of recruitment
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United States of America
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Disease/condition/study domain
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Atopic dermatitis
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Participants - inclusion criteria
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1. Ages 3 months to less than 18 years
2. Clinically diagnosed atopic dermatitis greater than or equal to 20% of total body surface area (BSA)
3. Not pregnant
4. Using acceptable birth control
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Participants - exclusion criteria
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1. Pregnant or nursing
2. Use of concomitant therapies for atopic dermatitis
3. Untreated bacterial, tubercular, fungal or viral lesion of the skin
4. Known sensitivity to any constituents of the study drug
5. Significant disease of the hepatic, renal, endocrine, musculoskeletal or nervous system or any gross physical impairment
6.Irregular sleep schedules
7. History of chronic drug or alcohol abuse
8. Investigational treatment within 30 days prior to study
9. Being treated for or history of melanoma in the past five years
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Anticipated start date
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21/06/2004
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Anticipated end date
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15/03/2005
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Status of trial
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Completed
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Patient information material
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Target number of participants
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120 - 30 per cohort
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Interventions
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Fluocinonide 0.1% applied, for 14 days, once daily versus twice daily.
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Primary outcome measure(s)
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Evaluate the effect of fluocinonide 0.1% cream to suppress the HPA axis
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Secondary outcome measure(s)
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1. Serum cortisol levels before and after stimulation with cosyntropin
2. Skin safety evaluations (signs and symptoms of skin atrophy, telangiectasia, and pigmentation changes)
3. Vital signs and weight
4. Evaluation of any adverse events reported during the study
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Sources of funding
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Medicis Pharmaceutical Corporation
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Trial website
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Publications
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Results: http://www.ncbi.nlm.nih.gov/pubmed/17178982
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Contact name
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Dr
Lester
Fahrner
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Address
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Christie Clinic on University
101 West University Avenue
Champaign
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City/town
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Illinois
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Zip/Postcode
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61820
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Country
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United States of America
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Sponsor
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Medicis Pharmaceutical Corporation (USA)
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Address
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8125 North Hayden Road
Scottsdale
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City/town
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Arizona
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Zip/Postcode
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85258
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Country
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United States of America
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Date applied
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29/03/2006
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Last edited
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08/05/2008
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Date ISRCTN assigned
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20/04/2006
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