Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02353897
Other study ID # Y-79-52120-201
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2014
Est. completion date July 2016

Study information

Verified date November 2020
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Australia ERASE Malvern
Australia SouthDerm Sydney
Brazil Clinica Laura Bariquelo Buratini Botucatu
Czechia Estetická Dermatologie Brno
Czechia BcD Clinic s.r.o. Praha
Kazakhstan Laser Center DARUS Almaty
Lebanon Dr Haddad Clinics Beirut
Russian Federation Centre of Aesthetic Medicine "Chistie prudi" Moscow
Russian Federation Plastic Surgery Institute Moscow
Russian Federation Preventive Medicine Clinic "Vallex M" Moscow
Russian Federation FI IF & TC & apos; Eye microsurgery & apos Novosibirsk
Russian Federation Clinic of Aesthetic Medicine St Petersburg
Turkey Kocaeli University School of Medecine Umuttepe Kocaeli
Ukraine Clinic of Aesthetic medicine "Ankor" Kyiv

Sponsors (1)

Lead Sponsor Collaborator
Ipsen

Countries where clinical trial is conducted

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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 To describe patient individual expectations. Assessed by patient auto questionnaire completion Within 3 weeks ±7 days of visit 1 and 2
Secondary To assess patient satisfaction after one and two injection cycles of Dysport. Assessed by patient auto questionnaire completion Within 3 weeks ±7 days of visit 1 and 2
Secondary To describe factors associated with patient satisfaction such as attractiveness, self-esteem, self-perceived age, desire to receive another injection. Assessed by patient auto questionnaire completion Within 3 weeks ±7 days of visit 1 and 2
Secondary To assess the GL severity (at rest and maximum frown) as per usual practice. Physician assessment using GL severity scale Baseline (visit 1) and visit 3
Secondary To assess physician satisfaction after one and three injection cycles of Dysport. 5 point Likert scale Visit 1 follow up visit and visit 3 follow up visit (if performed)
Secondary 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
See also
  Status Clinical Trial Phase
Completed NCT04096326 - AGN-151586 Dose-Ranging Study for Treatment of Glabellar Lines Phase 2
Completed NCT02961673 - The Safety and Efficacy Study of HU-014 Versus Botox® in Subject With Moderate to Severe Glabellar Lines Phase 1/Phase 2
Completed NCT01271452 - Safety and Efficacy of Two Types of Botulinum Toxin Type A For the Treatment of Glabellar Lines Phase 4
Completed NCT05013424 - A Study of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines Phase 2
Completed NCT01189760 - Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines Phase 3
Completed NCT05100199 - A Study to the Assess the Change in Condition and Adverse Events of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines Phase 2
Completed NCT03721016 - MT10109L in the Treatment of Glabellar Lines (GL) With or Without Concurrent Treatment of Lateral Canthal Lines (LCL) Phase 3
Completed NCT04157686 - MT10109L in the Long-term, Open-label Treatment of Glabellar Lines (GL) and Lateral Canthal Lines (LCL) Phase 3
Completed NCT03732833 - MT10109L in the Treatment of Lateral Canthal Lines With or Without Concurrent Treatment of Glabellar Lines Phase 3
Completed NCT06212960 - Evaluate the Safety and Explore the Efficacy of DWP712 With Moderate to Severe Glabellar Lines Phase 1
Completed NCT05089357 - Non-interventional Study, Long Term Treatment on Glabellar Lines With Dysport® in Subjects of Chinese Origin
Completed NCT00408785 - A Study Of BOTOX For The Treatment Of Glabellar Lines Phase 3
Completed NCT05380154 - Efficacy and Safety Assessment of Botulax® and BOTOX® for Improvement of Glabellar Lines. Phase 3
Completed NCT01224015 - Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines Phase 3
Completed NCT05248880 - A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Toxin-Naïve Adult Participants With Glabellar Lines Phase 3
Completed NCT03216408 - Clinical Study to Evaluate the Efficacy and Safety of Neuronox and Botox With Moderate to Severe Glabellar Lines Phase 3
Recruiting NCT06308198 - A Study to Evaluate AGN-151586 Intramuscular Injections in Adult Participants for Treatment of Glabellar Lines Phase 3
Completed NCT05298449 - Phase 2 of HU-045 in Glabellar Lines Phase 2
Not yet recruiting NCT06246552 - Clinical Trial to Evaluate the Safety and Efficacy of JTM201 to Treat Moderate or Severe Glabellar Lines Phase 2
Completed NCT05248867 - A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines Phase 3