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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02353897

Acronym

APPEAL

Enrollment

150

Registered

2015-02-03

Start date

2014-10-31

Completion date

2016-07-31

Last updated

2020-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glabellar Lines

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
To assess patient satisfaction regarding GL after three injection cycles of Dysport.	Within 3 weeks ±7 days of visit 3	Assessed by patient auto questionnaire completion

Secondary

Measure	Time frame	Description
To assess patient satisfaction after one and two injection cycles of Dysport.	Within 3 weeks ±7 days of visit 1 and 2	Assessed by patient auto questionnaire completion
To describe factors associated with patient satisfaction such as attractiveness, self-esteem, self-perceived age, desire to receive another injection.	Within 3 weeks ±7 days of visit 1 and 2	Assessed by patient auto questionnaire completion
To describe patient individual expectations.	Within 3 weeks ±7 days of visit 1 and 2	Assessed by patient auto questionnaire completion
To assess physician satisfaction after one and three injection cycles of Dysport.	Visit 1 follow up visit and visit 3 follow up visit (if performed)	5 point Likert scale
To describe Dysport injection practices: muscles injected, total injected units, total volume injected, number of injection points and interval between injections.	From visit 1 until the end of the study	—
To assess the GL severity (at rest and maximum frown) as per usual practice.	Baseline (visit 1) and visit 3	Physician assessment using GL severity scale

Countries

Australia, Brazil, Czechia, Kazakhstan, Lebanon, Russia, Turkey (Türkiye), Ukraine

Outcome results