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

Completed

• Conditions: Health Knowledge, Attitudes, Practice

• Registration Number: NCT01800474
• Lead Sponsor: Galderma R&D

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.

Study Timeline

• Study First Submitted: 2013-01-18
• Study Start: 2013-02
• Study First Submitted QC: 2013-02-25
• Study First Posted: 2013-02-27
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-02
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 582

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (4)

Centre Médical Saint-Jean; 🇫🇷 Arras, France

Clínica Dermatológica Dr. Guillén; 🇪🇸 Valencia, Spain

Swansea Laser Clinic; 🇬🇧 Swansea, United Kingdom

Klinikum Darmstadt Hautklinik; 🇩🇪 Darmstadt, Germany