Place of Flixovate® in the Treatment Pathway and Its Conditions of Use in Infants Aged From 3 to 12 Months Between 2010 and 2012 by French GPs and Private Paediatricians

Completed

• Conditions: Dermatitis, Atopic

• Registration Number: NCT01920464
• Lead Sponsor: GlaxoSmithKline

Brief Summary

this study has been request by french health authorities to evaluate the use of flixovate in infants and its place in the treatment pathway.

this study has 2 main pbjectives: 1/ Evaluation of changes in the prescription share of Flixovate® compared to other topical corticosteroids (low, medium and high potency) in the population of infants aged from 3 to 12 months, from 1st January 2010 to 31st December 2012. 2/Description of the conditions of use of Flixovate® in infants aged less than 12 months (infant profile, dosage form, dosage, treatment duration, prior, concomitant and subsequent treatments etc.).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-06-27
• Study First Submitted QC: 2013-08-08
• Study First Posted: 2013-08-12
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-11
• Last Update Posted: 2014-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Analysis of changes in share of prescriptions:

• Infants who received at least one prescription of topical steroids between 1st January 2010 and 31st December 2012.
• Infants aged 3 to 12 months on the day of prescription of topical steroids.

Description of the conditions of use and patient profiles:

• Infants who received at least one prescription of topical steroids between 1st January 2010 and 31st December 2012.
• Infants aged 3 to 12 months on the day of prescription of topical steroids.

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Description of the conditions of use of Flixovate® in infants aged less than 12 months	baseline	data collected and analysed: Profile of prescribers (age, sex, geographic location), Profile of infants (age, age group, gender, Z-score, medical history), Conditions (diagnoses corresponding to prescriptions of Flixovate®, dosage, mean duration of treatment and duration in classes, previous treatment, concomitant medications, treatments prescribed after discontinuation of Flixovate®. (emollients and other topical steroids).
- Evaluation of changes in the prescription share of Flixovate® compared to other topical corticosteroids (low, medium and high potency) in the population of infants aged from 3 to 12 months, from 1st January 2010 to 31st December 2012.	baseline, one year, 2 years, 3 years	data collected and analysed: Profile of prescribers (age, gender, geographical location). Number of prescriptions of Flixovate® and other topical steroids by class, INN and brand name