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A multe-center, non-interventional study in Europe to evaluate Pliaglis in daily practice
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.
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| Measure | Description | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Pliaglis | Pain intensity by VAS, satisfaction with pain reduction, willingness to re-use/recommend Pliaglis | After completing Pliaglis treatment and procedure, i.e. at the end of the site visit (day of application) |
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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:
Exclusion Criteria:
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Patient aiming to perform one or more of the following aesthetic procedures:
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| Name | Affiliation | Role |
|---|---|---|
| Max Murison, Dr. | National coordinating investigator | Principal Investigator |
| Maurizio Podda, Dr | National coordinating investigator | Principal Investigator |
| Hugues Cartier, Dr | National coordinating investigator | Principal Investigator |
| Carlos Guillén, Dr | National coordinating investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Médical Saint-Jean | Arras | 62000 | France | |||
| Klinikum Darmstadt Hautklinik |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29601618 | Derived | 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. |
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| ID | Term |
|---|---|
| D001519 | Behavior |
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| Darmstadt |
| 64297 |
| Germany |
| Clínica Dermatológica Dr. Guillén | Valencia | 46003 | Spain |
| Swansea Laser Clinic | Swansea | SA7 9FH | United Kingdom |