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

Dermatitis, Atopic Clinical Trial

— flixovate HAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01920464
• Other study ID #: 116296
• Status: Completed
• Phase: N/A
• First received: June 27, 2013
• Last updated: September 11, 2014
• Start date: April 2013
• Est. completion date: October 2013

Study information

• Verified date: September 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: GSK observational studyFrance: CCTRIS, CNOM & CNILFrance: Haute Autorité de santé (HAS)
• Study type: Observational

Clinical Trial 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.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Months

Eligibility

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:

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Dermatitis, Atopic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of the conditions of use of Flixovate® in infants aged less than 12 months	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).	baseline	No
Primary	- 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.	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	baseline, one year, 2 years, 3 years	No