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
Secondary identifying numbers	MP-0201-07

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

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

Study design	Multicenter, multiple-dose, open-label study with four sequential age cohorts
Primary study design	Interventional
Secondary study design	Cohort study
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study hypothesis	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
Condition	Atopic dermatitis
Intervention	Fluocinonide 0.1% applied, for 14 days, once daily versus twice daily.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Fluocinonide
Primary outcome measure	Evaluate the effect of fluocinonide 0.1% cream to suppress the HPA axis
Secondary outcome measures	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
Overall study start date	21/06/2004
Overall study end date	15/03/2005

Participant type(s)	Patient
Age group	Child
Lower age limit	3 Months
Upper age limit	17 Years
Sex	Both
Target number of participants	120 - 30 per cohort
Participant 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
Participant 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
Recruitment start date	21/06/2004
Recruitment end date	15/03/2005

Christie Clinic on University

Illinois
61820
United States of America

Medicis Pharmaceutical Corporation (USA)
Industry

8125 North Hayden Road
Scottsdale
Arizona
85258
United States of America

"ROR"	https://ror.org/01zgpn844

Industry

Medicis Pharmaceutical Corporation

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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