Last updated: 11/03/2018 19:03:19
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 paediatriciansflixovate HAS
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Description of the conditions of use of Flixovate® in infants aged less than 12 months
Timeframe: baseline
- 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.
Timeframe: baseline, one year, 2 years, 3 years
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
160
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Dermatitis, Atopic
Product
fluticasone propionate
Collaborators
Not applicable
Study date(s)
April 2013 to February 2015
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
0 - 12 months
Accepts healthy volunteers
No
- 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.
- none
Inclusion and exclusion criteria
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
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2015-20-02
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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