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

Glabellar Lines Clinical Trial

— APPEAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02353897
• Other study ID #: Y-79-52120-201
• Status: Completed
• Start date: October 2014
• Est. completion date: July 2016

Study information

• Verified date: November 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• 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.

Related Conditions & MeSH terms

• Glabellar Lines

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