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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02353897
• Date of registration: 29/01/2015
• Prospective Registration: No
• Primary sponsor: Ipsen
• Public title: Patient and Physician's Satisfaction After a Long Term Treatment of Glabellar Lines With Dysport® APPEAL
• Scientific title: An Assessment of Patient and Physician's Satisfaction After a Long Term Treatment of Glabellar Lines With Dysport®.
• Date of first enrolment: October 2014
• Target sample size: 150
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02353897
• Study type: Observational

Countries of recruitment

Australia, Brazil, Czech Republic, Czechia, Kazakhstan, Lebanon, Russian Federation, Turkey, Ukraine

Contacts

• Name: Ipsen Medical Director
• Affiliation: Ipsen

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Glabellar Lines

Primary Outcome(s)

To assess patient satisfaction regarding GL after three injection cycles of Dysport. [Time Frame: Within 3 weeks ±7 days of visit 3]

Secondary Outcome(s)

To assess the GL severity (at rest and maximum frown) as per usual practice. [Time Frame: Baseline (visit 1) and visit 3]

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]

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]

To assess patient satisfaction after one and two injection cycles of Dysport. [Time Frame: Within 3 weeks ±7 days of visit 1 and 2]

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)]

To describe patient individual expectations. [Time Frame: Within 3 weeks ±7 days of visit 1 and 2]

Secondary ID(s)

Y-79-52120-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors