Clinical trial NCT01800474: A Non-interventional Study to Evaluate the Use of Pliaglis in Daily Practice
Official title: A Non-interventional Study to Evaluate the Use of Pliaglis in Daily Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Knowledge, Attitudes, Practice
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2013-02-27
Enrollment: 582
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-market safety profile of Pliaglis assessed on spontaneously reported Adverse Reactions
timeFrame: After Pliaglis application and throughout the site visit (day of application)
Secondary outcomes:
measure: Efficacy of Pliaglis
timeFrame: After completing Pliaglis treatment and procedure, i.e. at the end of the site visit (day of application)
Other outcomes:
Locations:
city: Arras
country: France
facility: Centre Médical Saint-Jean
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt Hautklinik
city: Valencia
country: Spain
facility: Clínica Dermatológica Dr. Guillén
city: Swansea
country: United Kingdom
facility: Swansea Laser Clinic
Study officials:
affiliation: National coordinating investigator
name: Max Murison, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: National coordinating investigator
name: Maurizio Podda, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: National coordinating investigator
name: Hugues Cartier, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: National coordinating investigator
name: Carlos Guillén, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.