Condition category
Skin and Connective Tissue Diseases
Date applied
29/03/2006
Date assigned
20/04/2006
Last edited
08/05/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lester Fahrner

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MP-0201-07

Study information

Scientific title

Acronym

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

Approved by the Essex Institutional Review Board, Inc. on 23/06/2004

Study design

Multicenter, multiple-dose, open-label study with four sequential age cohorts

Primary study design

Interventional

Secondary study design

Cohort study

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Atopic dermatitis

Intervention

Fluocinonide 0.1% applied, for 14 days, once daily versus twice daily.

Intervention type

Drug

Phase

Not Specified

Drug names

Fluocinonide

Primary outcome measures

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 trial start date

21/06/2004

Overall trial end date

15/03/2005

Reason abandoned

Eligibility

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 type

Patient

Age group

Child

Gender

Both

Target number of participants

120 - 30 per cohort

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

Locations

Countries of recruitment

United States of America

Trial participating centre

Christie Clinic on University
Illinois
61820
United States of America

Sponsor information

Organisation

Medicis Pharmaceutical Corporation (USA)

Sponsor details

8125 North Hayden Road
Scottsdale
Arizona
85258
United States of America

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Medicis Pharmaceutical Corporation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results: http://www.ncbi.nlm.nih.gov/pubmed/17178982

Publication citations

  1. Results

    Schlessinger J, Miller B, Gilbert RD, Plott RT, , An open-label adrenal suppression study of 0.1% fluocinonide cream in pediatric patients with atopic dermatitis., Arch Dermatol, 2006, 142, 12, 1568-1572, doi: 10.1001/archderm.142.12.1568.

Additional files

Editorial Notes