A Non-interventional Study to Evaluate the Use of Pliaglis in Daily Practice

A multe-center, non-interventional study in Europe to evaluate Pliaglis in daily practice

Study Overview

• Status: Completed
• Conditions: Health Knowledge, Attitudes, 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 Type: Observational
• Enrollment (Actual): 582

Contacts and Locations

Study Locations

• France
  • Arras, France, 62000
    • Centre Médical Saint-Jean
• Germany
  • Darmstadt, Germany, 64297
    • Klinikum Darmstadt Hautklinik
• Spain
  • Valencia, Spain, 46003
    • Clínica Dermatológica Dr. Guillén
• United Kingdom
  • Swansea, United Kingdom, SA7 9FH
    • Swansea Laser Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Principal Investigator: 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: January 18, 2013
• First Submitted That Met QC Criteria: February 25, 2013
• First Posted (Estimate): February 27, 2013

Study Record Updates

• Last Update Posted (Actual): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 05PT1209