An Open-Label Adrenal Suppression Study of Fluocinonide 0.1% Cream in Pediatric Subjects with Atopic Dermatitis

ISRCTN	ISRCTN71227633
DOI	https://doi.org/10.1186/ISRCTN71227633
Protocol serial number	MP-0201-07
Sponsor	Medicis Pharmaceutical Corporation (USA)
Funder	Medicis Pharmaceutical Corporation

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Lester Fahrner
Scientific

Christie Clinic on University
101 West University Avenue
Champaign
Illinois
61820
United States of America

Primary study design	Interventional
Study design	Multicenter, multiple-dose, open-label study with four sequential age cohorts
Secondary study design	Cohort study
Scientific title
Study objectives	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
Ethics approval(s)	Approved by the Essex Institutional Review Board, Inc. on 23/06/2004
Health condition(s) or problem(s) studied	Atopic dermatitis
Intervention	Fluocinonide 0.1% applied, for 14 days, once daily versus twice daily.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Fluocinonide
Primary outcome measure(s)	Evaluate the effect of fluocinonide 0.1% cream to suppress the HPA axis
Key secondary outcome measure(s)	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
Completion date	15/03/2005

Participant type(s)	Patient
Age group	Child
Lower age limit	3 Months
Upper age limit	17 Years
Sex	All
Target sample size at registration	120
Key inclusion criteria	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
Key exclusion criteria	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
Date of first enrolment	21/06/2004
Date of final enrolment	15/03/2005

Christie Clinic on University

Illinois
61820
United States of America

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results:	01/12/2006		Yes	No