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OpenTrials
Completed

NCT Number: NCT02353897

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.

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Key information

Conditions

Glabellar Lines

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ERASE, Malvern, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

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

    Assessed by patient auto questionnaire completion

Secondary outcomes

  1. To describe patient individual expectations.

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

    Assessed by patient auto questionnaire completion

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

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

    Assessed by patient auto questionnaire completion

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

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

    Assessed by patient auto questionnaire completion

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

    Time frame: Baseline (visit 1) and visit 3

    Physician assessment using GL severity scale

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

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

    5 point Likert scale

  6. 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

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

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

Acronym: APPEAL

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 3, 2015
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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