Clinical trial NCT02353897: Patient and Physician's Satisfaction After a Long Term Treatment of Glabellar Lines With Dysport®
Official title: An Assessment of Patient and Physician's Satisfaction After a Long Term Treatment of Glabellar Lines With Dysport®.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glabellar Lines
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2015-02-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Private practices and clinics

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.


Eligibility 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.

Primary outcomes:
measure: To assess patient satisfaction regarding GL after three injection cycles of Dysport.
timeFrame: Within 3 weeks ±7 days of visit 3
Secondary outcomes:
measure: To describe patient individual expectations.
timeFrame: Within 3 weeks ±7 days of visit 1 and 2
measure: To assess patient satisfaction after one and two injection cycles of Dysport.
timeFrame: Within 3 weeks ±7 days of visit 1 and 2
measure: To describe factors associated with patient satisfaction such as attractiveness, self-esteem, self-perceived age, desire to receive another injection.
timeFrame: Within 3 weeks ±7 days of visit 1 and 2
measure: To assess the GL severity (at rest and maximum frown) as per usual practice.
timeFrame: Baseline (visit 1) and visit 3
measure: To assess physician satisfaction after one and three injection cycles of Dysport.
timeFrame: Visit 1 follow up visit and visit 3 follow up visit (if performed)
measure: To describe Dysport injection practices: muscles injected, total injected units, total volume injected, number of injection points and interval between injections.
timeFrame: From visit 1 until the end of the study
Other outcomes:
Locations:
city: Malvern
country: Australia
facility: ERASE
city: Sydney
country: Australia
facility: SouthDerm
city: Botucatu
country: Brazil
facility: Clinica Laura Bariquelo Buratini
city: Brno
country: Czechia
facility: Estetická Dermatologie
city: Praha
country: Czechia
facility: BcD Clinic s.r.o.
city: Almaty
country: Kazakhstan
facility: Laser Center DARUS
city: Beirut
country: Lebanon
facility: Dr Haddad Clinics
city: Moscow
country: Russian Federation
facility: Centre of Aesthetic Medicine "Chistie prudi"
city: Moscow
country: Russian Federation
facility: Preventive Medicine Clinic "Vallex M"
city: Moscow
country: Russian Federation
facility: Plastic Surgery Institute
city: Novosibirsk
country: Russian Federation
facility: FI IF & TC & apos; Eye microsurgery & apos
city: St Petersburg
country: Russian Federation
facility: Clinic of Aesthetic Medicine
city: Kocaeli
country: Turkey
facility: Kocaeli University School of Medecine Umuttepe
city: Kyiv
country: Ukraine
facility: Clinic of Aesthetic medicine "Ankor"
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.