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Trial record 20 of 41 for:    Synera

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

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ClinicalTrials.gov Identifier: NCT01800474
Recruitment Status : Completed
First Posted : February 27, 2013
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
Q-Med AB

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

Condition or disease
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
Actual Enrollment : 582 participants
Time Perspective: Cross-Sectional
Official Title: A Non-interventional Study to Evaluate the Use of Pliaglis in Daily Practice
Study Start Date : February 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01800474


Locations
France
Centre Médical Saint-Jean
Arras, France, 62000
Germany
Klinikum Darmstadt Hautklinik
Darmstadt, Germany, 64297
Spain
Clínica Dermatológica Dr. Guillén
Valencia, Spain, 46003
United Kingdom
Swansea Laser Clinic
Swansea, United Kingdom, SA7 9FH
Sponsors and Collaborators
Q-Med AB
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT01800474     History of Changes
Other Study ID Numbers: 05PT1209
First Posted: February 27, 2013    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: February 2015