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

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.).

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Key information

Conditions

Dermatitis, Atopic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Description of the conditions of use of Flixovate® in infants aged less than 12 months

Time frame: 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.

Time frame: 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Acronym: flixovate HAS

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Aug 12, 2013
Registry last updated: Sep 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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