This trial is active, not recruiting.

Condition glabellar lines
Sponsor Ipsen
Start date October 2014
End date September 2016
Trial size 150 participants
Trial identifier NCT02353897, Y-79-52120-201


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

To assess patient satisfaction regarding GL after three injection cycles of Dysport.
time frame: Within 3 weeks ±7 days of visit 3

Secondary Outcomes

To describe patient individual expectations.
time frame: Within 3 weeks ±7 days of visit 1 and 2
To assess patient satisfaction after one and two injection cycles of Dysport.
time frame: 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.
time frame: Within 3 weeks ±7 days of visit 1 and 2
To assess the GL severity (at rest and maximum frown) as per usual practice.
time frame: Baseline (visit 1) and visit 3
To assess physician satisfaction after one and three injection cycles of Dysport.
time frame: Visit 1 follow up visit and visit 3 follow up visit (if performed)
To describe Dysport injection practices: muscles injected, total injected units, total volume injected, number of injection points and interval between injections.
time frame: From visit 1 until the end of the study

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title An Assessment of Patient and Physician's Satisfaction After a Long Term Treatment of Glabellar Lines With Dysport®.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Ipsen.