Dermatitis, Atopicflixovate HASNCT01920464
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
An observational study of Dermatitis, Atopic, run by GlaxoSmithKline.
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… Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Dermatitis, Atopic
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: retrospective database extraction
Who may be able to join
- 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.
Who cannot join
- none
About this study
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.).
- Conditions
- Dermatitis, Atopic
- Medical subject headings
- Dermatitis, Atopic
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
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
Measured: baseline, one year, 2 years, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920464
- Sponsor's protocol ID
- 116296
- Acronym
- flixovate HAS
- Status last verified
- Sep 2014
- First submitted
- 27 Jun 2013
- Last updated
- 15 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01920464
- Acronym / sponsor ID
- flixovate HAS / 116296
- Conditions
- Dermatitis, Atopic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 12 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.).
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- retrospective database extraction
Key inclusion criteria (6 listed)
- 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.
- 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.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatitis, Atopic, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the conditions of use of Flixovate® in infants aged less than 12 months (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2014.