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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01920464

Acronym

flixovate HAS

Enrollment

160

Registered

2013-08-12

Start date

2013-04-30

Completion date

2013-10-31

Last updated

2014-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatitis, Atopic

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.).

Interventions

None listed

Study design

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 12 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results