Health Knowledge, Attitudes, Practice
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Galderma R&D
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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: 1. Pulsed-dye laser therapy 2. Laser-assisted hair removal 3. Non-ablative laser resurfacing 4. Dermal filler injection 5. Vascular access
Exclusion criteria
* Patient treated with other injectable or topical anaesthetic(s) for the pre-defined aesthetic procedure * Previous participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-market safety profile of Pliaglis assessed on spontaneously reported Adverse Reactions | After Pliaglis application and throughout the site visit (day of application) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Pliaglis | After completing Pliaglis treatment and procedure, i.e. at the end of the site visit (day of application) | Pain intensity by VAS, satisfaction with pain reduction, willingness to re-use/recommend Pliaglis |
Countries
France, Germany, Spain, United Kingdom
Outcome results
None listed