Patient and Physician's Satisfaction After a Long Term Treatment of Glabellar Lines With Dysport®
- Conditions
- Glabellar Lines
- Registration Number
- NCT02353897
- Lead Sponsor
- Ipsen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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
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 describe patient individual expectations. Within 3 weeks ±7 days of visit 1 and 2 Assessed by patient auto questionnaire completion
Trial Locations
- Locations (14)
ERASE
🇦🇺Malvern, Australia
Laser Center DARUS
🇰🇿Almaty, Kazakhstan
BcD Clinic s.r.o.
🇨🇿Praha, Czechia
Clinic of Aesthetic medicine "Ankor"
🇺🇦Kyiv, Ukraine
Clinica Laura Bariquelo Buratini
🇧🇷Botucatu, Brazil
FI IF & TC & apos; Eye microsurgery & apos
🇷🇺Novosibirsk, Russian Federation
Plastic Surgery Institute
🇷🇺Moscow, Russian Federation
SouthDerm
🇦🇺Sydney, Australia
Estetická Dermatologie
🇨🇿Brno, Czechia
Centre of Aesthetic Medicine "Chistie prudi"
🇷🇺Moscow, Russian Federation
Preventive Medicine Clinic "Vallex M"
🇷🇺Moscow, Russian Federation
Dr Haddad Clinics
🇱🇧Beirut, Lebanon
Kocaeli University School of Medecine Umuttepe
🇹🇷Kocaeli, Turkey
Clinic of Aesthetic Medicine
🇷🇺St Petersburg, Russian Federation