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

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

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 Overview

• Status: Completed
• Conditions: Glabellar Lines

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Australia
  • Malvern, Australia, 3144
    • ERASE
  • Sydney, Australia, 2217
    • SouthDerm
• Brazil
  • Botucatu, Brazil, 18603-390
    • Clinica Laura Bariquelo Buratini
• Czechia
  • Brno, Czechia, 60200
    • Estetická Dermatologie
  • Praha, Czechia, 14000
    • BcD Clinic s.r.o.
• Kazakhstan
  • Almaty, Kazakhstan, 050022
    • Laser Center DARUS
• Lebanon
  • Beirut, Lebanon, 70920
    • Dr Haddad Clinics
• Russian Federation
  • Moscow, Russian Federation, 105062
    • Centre of Aesthetic Medicine "Chistie prudi"
  • Moscow, Russian Federation, 117630
    • Preventive Medicine Clinic "Vallex M"
  • Moscow, Russian Federation, 119002
    • Plastic Surgery Institute
  • Novosibirsk, Russian Federation, 630071
    • FI IF & TC & apos; Eye microsurgery & apos
  • St Petersburg, Russian Federation, 197110
    • Clinic of Aesthetic Medicine
• Turkey
  • Kocaeli, Turkey, 41380
    • Kocaeli University School of Medecine Umuttepe
• Ukraine
  • Kyiv, Ukraine, 03087
    • Clinic of Aesthetic medicine "Ankor"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Private practices and clinics

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To describe patient individual expectations.	Assessed by patient auto questionnaire completion	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	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	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	Baseline (visit 1) and visit 3
To assess physician satisfaction after one and three injection cycles of Dysport.	5 point Likert scale	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.		From visit 1 until the end of the study

Collaborators and Investigators

• Sponsor: Ipsen

Publications and helpful links

General Publications

• Gubanova E, Haddad Tabet M, Bergerova Y, Moiseieva O, Chemeris A, Sanches E, Sharova A, Rodriguez Pose L, Raymond R, Prygova I, Carlisle I. Assessment of Subject and Physician Satisfaction after Long-Term Treatment of Glabellar Lines with AbobotulinumtoxinA (Dysport(R)/Azzalure(R)): Primary Results of the APPEAL Noninterventional Study. Aesthetic Plast Surg. 2018 Dec;42(6):1672-1680. doi: 10.1007/s00266-018-1200-4. Epub 2018 Aug 17.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: January 29, 2015
• First Submitted That Met QC Criteria: January 29, 2015
• First Posted (Estimate): February 3, 2015

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Y-79-52120-201