Health Knowledge, Attitudes, PracticeNCT01800474
A Non-interventional Study to Evaluate the Use of Pliaglis in Daily Practice
An observational study of Health Knowledge, Attitudes, Practice, run by Galderma R&D at 4 sites in 4 countries.
Trial summary
A multe-center, non-interventional study in Europe to evaluate Pliaglis in daily practice Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Knowledge, Attitudes, Practice
- How many people
- 582 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Feb 2013to Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient aiming to perform one or more of the following aesthetic procedures: 1. Pulsed-dye laser therapy 2. Laser-assisted hair removal 3. Non-ablative laser resurfacing 4. Dermal filler injection 5. Vascular access
Who may be able to join
- Signed informed consent
- Patient treated with Pliaglis by the Investigator or other healthcare professional according to label (refer to SmPC)
- Patient had already consented to receive any one or more of the following aesthetic procedures after Pliaglis administration:
- Pulsed-dye laser therapy
- Laser-assisted hair removal
- Non-ablative laser resurfacing
- Dermal filler injection
- Vascular access
Who cannot join
- Patient treated with other injectable or topical anaesthetic(s) for the pre-defined aesthetic procedure
- Previous participation in this study
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
A multe-center, non-interventional study in Europe to evaluate Pliaglis in daily practice
Read the detailed description
A multi-center, non-interventional study, including up to 700 subjects at approximately 70 sites in 5 European countries to evaluate the post-market safety profile of Pliaglis and the efficacy of Pliaglis in terms of pain reduction, satisfaction with the product and daily practice use prior to pre-defined aesthetic procedures.
- Conditions
- Health Knowledge, Attitudes, Practice
- Medical subject headings
- Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-market safety profile of Pliaglis assessed on spontaneously reported Adverse Reactions
Measured: After Pliaglis application and throughout the site visit (day of application)
Secondary outcomes (1)
Efficacy of Pliaglis
Pain intensity by VAS, satisfaction with pain reduction, willingness to re-use/recommend Pliaglis
Measured: After completing Pliaglis treatment and procedure, i.e. at the end of the site visit (day of application)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe 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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 582 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Max Murison, Dr., Principal investigator, National coordinating investigatorMaurizio Podda, Dr, Principal investigator, National coordinating investigatorHugues Cartier, Dr, Principal investigator, National coordinating investigatorCarlos Guillén, Dr, Principal investigator, National coordinating investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800474
- Sponsor's protocol ID
- 05PT1209
- Status last verified
- Feb 2015
- First submitted
- 18 Jan 2013
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Jain R, Arias GM, Naranjo P, Murison M, Lopez Estebaranz JL, Fratila A, Prager W, Barona CG, Weidmann M, Dahan S, Cartier H, Sattler G, Podda M. The Use of a Self-Occluding Topical Anasthetic in Daily Practice: A Non-Interventional Study. J Drugs Dermatol. 2018 Apr 1;17(4):413-418.
PubMed 29601618
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Study to Evaluate the Use of Pliaglis in Daily Practice
- ClinicalTrials.gov ID
- NCT01800474
- Acronym / sponsor ID
- 05PT1209
- Conditions
- Health Knowledge, Attitudes, Practice
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 582 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Feb 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.
A multe-center, non-interventional study in Europe to evaluate Pliaglis in daily practice
Detailed description
A multi-center, non-interventional study, including up to 700 subjects at approximately 70 sites in 5 European countries to evaluate the post-market safety profile of Pliaglis and the efficacy of Pliaglis in terms of pain reduction, satisfaction with the product and daily practice use prior to pre-defined aesthetic procedures.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient aiming to perform one or more of the following aesthetic procedures: 1. Pulsed-dye laser therapy 2. Laser-assisted hair removal 3. Non-ablative laser resurfacing 4. Dermal filler injection 5. Vascular access
Key inclusion criteria (8 listed)
- Signed informed consent
- Patient treated with Pliaglis by the Investigator or other healthcare professional according to label (refer to SmPC)
- Patient had already consented to receive any one or more of the following aesthetic procedures after Pliaglis administration:
Key exclusion criteria (2 listed)
- Patient treated with other injectable or topical anaesthetic(s) for the pre-defined aesthetic procedure
- Previous participation in this study
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
Post-market safety profile of Pliaglis assessed on spontaneously reported Adverse Reactions
Time frame: After Pliaglis application and throughout the site visit (day of application)
1 secondary outcome
Efficacy of Pliaglis
Time frame: After completing Pliaglis treatment and procedure, i.e. at the end of the site visit (day of application)
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 25 Aug 2022.
- Derived from this study: PubMed 29601618Jain R, Arias GM, Naranjo P, Murison M, Lopez Estebaranz JL, Fratila A, Prager W, Barona CG, Weidmann M, Dahan S, Cartier H, Sattler G, Podda M. The Use of a Self-Occluding Topical Anasthetic in Daily Practice: A Non-Interventional Study. J Drugs Dermatol. 2018 Apr 1;17(4):413-418.
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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.
Max Murison, Dr. principal investigator
National coordinating investigator
Maurizio Podda, Dr principal investigator
National coordinating investigator
Hugues Cartier, Dr principal investigator
National coordinating investigator
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Knowledge, Attitudes, Practice, run by Galderma R&D at 4 sites in 4 countries.
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 8 inclusion and 2 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 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Germany, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Post-market safety profile of Pliaglis assessed on spontaneously reported Adverse Reactions (time frame: After Pliaglis application and throughout the site visit (day of application)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01800474, which also lists 1 linked publication.
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 25 Aug 2022; AzTrials last refreshed its copy on 1 Nov 2026.