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Completed

NCT Number: NCT01800474

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

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Key information

Conditions

Health Knowledge, Attitudes, Practice Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Médical Saint-Jean, Arras, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • Pulsed-dye laser therapy
  • Laser-assisted hair removal
  • Non-ablative laser resurfacing
  • Dermal filler injection
  • Vascular access

Exclusion criteria

  • Patient treated with other injectable or topical anaesthetic(s) for the pre-defined aesthetic procedure
  • Previous participation in this study

Treatment and study plan

Primary outcomes

  1. Post-market safety profile of Pliaglis assessed on spontaneously reported Adverse Reactions

    Time frame: After Pliaglis application and throughout the site visit (day of application)

Secondary outcomes

  1. Efficacy of Pliaglis

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 27, 2013
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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