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

Health Knowledge, Attitudes, Practice Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01800474
• Other study ID #: 05PT1209
• Status: Completed
• Start date: February 2013
• Est. completion date: December 2013

Study information

• Verified date: February 2015
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 582
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Health Knowledge, Attitudes, Practice

Locations

Country	Name	City	State
France	Centre Médical Saint-Jean	Arras
Germany	Klinikum Darmstadt Hautklinik	Darmstadt
Spain	Clínica Dermatológica Dr. Guillén	Valencia
United Kingdom	Swansea Laser Clinic	Swansea

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

France,  Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-market safety profile of Pliaglis assessed on spontaneously reported Adverse Reactions		After Pliaglis application and throughout the site visit (day of application)
Secondary	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)