Patient and Physician's Satisfaction After a Long Term Treatment of Glabellar Lines With Dysport®

Ipsen150 enrolled

Overview

This study aims to look at patient and physician satisfaction of long term Glabellar lines (GL) treatment with Dysport in a real life setting. It will also allow better understanding of what patients expect from the treatment, and the injection practices used by doctors.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Glabellar Lines

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patient with moderate to severe GL naïve of any type of aesthetic treatment/procedure (invasive and non-invasive) for GL who provided written informed consent to take part. * Patient who has prior to and independent of the study decided to undergo long term treatment of GL only (at least three cycles). * Patient able to comply with the protocol (completion of web questionnaires). * Patient whom physician intended to treat with Dysport independent of participation in the study. Exclusion Criteria: * Patient already included in this study. * Participation in an interventional trial within 30 days prior to study entry. * Patient who is at risk in terms of precautions, warnings, and contraindication (follow local Summary of Product Characteristics (SmPC) of Dysport). * Female patient who is pregnant, nursing or planning a pregnancy during the study. * Hypersensitivity to Dysport® or to its excipients. * Presence of infection at the proposed injection sites. * Presence of myasthenia gravis, Eaton Lambert syndrome or amyotrophic lateral sclerosis.

Locations (14)

ERASE

Malvern, Australia

SouthDerm

Sydney, Australia

Clinica Laura Bariquelo Buratini

Botucatu, Brazil

Outcomes

Primary Outcomes

To assess patient satisfaction regarding GL after three injection cycles of Dysport.

Assessed by patient auto questionnaire completion

Time frame: Within 3 weeks ±7 days of visit 3

Secondary Outcomes

To describe patient individual expectations.

Assessed by patient auto questionnaire completion

Time frame: Within 3 weeks ±7 days of visit 1 and 2

To assess patient satisfaction after one and two injection cycles of Dysport.

Assessed by patient auto questionnaire completion

Time frame: Within 3 weeks ±7 days of visit 1 and 2

To describe factors associated with patient satisfaction such as attractiveness, self-esteem, self-perceived age, desire to receive another injection.

Assessed by patient auto questionnaire completion

Time frame: Within 3 weeks ±7 days of visit 1 and 2

To assess the GL severity (at rest and maximum frown) as per usual practice.

Physician assessment using GL severity scale

Time frame: Baseline (visit 1) and visit 3

To assess physician satisfaction after one and three injection cycles of Dysport.

5 point Likert scale

Time frame: Visit 1 follow up visit and visit 3 follow up visit (if performed)

To describe Dysport injection practices: muscles injected, total injected units, total volume injected, number of injection points and interval between injections.

Time frame: From visit 1 until the end of the study

Data from ClinicalTrials.gov

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