NCT02353897

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

Geographic Reach
8 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 3, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

1.8 years

First QC Date

January 29, 2015

Last Update Submit

November 4, 2020

Conditions

Glabellar Lines

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • To describe patient individual expectations.

    Within 3 weeks ±7 days of visit 1 and 2

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

    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.

    Within 3 weeks ±7 days of visit 1 and 2

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

    Baseline (visit 1) and visit 3

  • 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)

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Private practices and clinics

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

ERASE

Malvern, 3144, Australia

Location

SouthDerm

Sydney, 2217, Australia

Location

Clinica Laura Bariquelo Buratini

Botucatu, 18603-390, Brazil

Location

Estetická Dermatologie

Brno, 60200, Czechia

Location

BcD Clinic s.r.o.

Prague, 14000, Czechia

Location

Laser Center DARUS

Almaty, 050022, Kazakhstan

Location

Dr Haddad Clinics

Beirut, 70920, Lebanon

Location

Centre of Aesthetic Medicine "Chistie prudi"

Moscow, 105062, Russia

Location

Preventive Medicine Clinic "Vallex M"

Moscow, 117630, Russia

Location

Plastic Surgery Institute

Moscow, 119002, Russia

Location

FI IF & TC & apos; Eye microsurgery & apos

Novosibirsk, 630071, Russia

Location

Clinic of Aesthetic Medicine

Saint Petersburg, 197110, Russia

Location

Kocaeli University School of Medecine Umuttepe

Kocaeli, 41380, Turkey (Türkiye)

Location

Clinic of Aesthetic medicine "Ankor"

Kyiv, 03087, Ukraine

Location

Related Publications (1)

  • 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.

    PMID: 30120518DERIVED

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2015

First Posted

February 3, 2015

Study Start

October 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

November 5, 2020

Record last verified: 2020-11

Locations

UA(1)RU(5)TU(1)CZ(2)BR(1)KA(1)LE(1)AU(2)