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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02353897
Recruitment Status : Completed
First Posted : February 3, 2015
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Ipsen

Tracking Information
First Submitted Date January 29, 2015
First Posted Date February 3, 2015
Last Update Posted Date December 21, 2018
Study Start Date October 2014
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 29, 2015)
To assess patient satisfaction regarding GL after three injection cycles of Dysport. [ Time Frame: Within 3 weeks ±7 days of visit 3 ]
Assessed by patient auto questionnaire completion
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02353897 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 29, 2015)
  • To describe patient individual expectations. [ Time Frame: Within 3 weeks ±7 days of visit 1 and 2 ]
    Assessed by patient auto questionnaire completion
  • To assess patient satisfaction after one and two injection cycles of Dysport. [ Time Frame: Within 3 weeks ±7 days of visit 1 and 2 ]
    Assessed by patient auto questionnaire completion
  • 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 ]
    Assessed by patient auto questionnaire completion
  • To assess the GL severity (at rest and maximum frown) as per usual practice. [ Time Frame: Baseline (visit 1) and visit 3 ]
    Physician assessment using GL severity scale
  • 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) ]
    5 point Likert scale
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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®.
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Private practices and clinics
Condition Glabellar Lines
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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(®)/Azzalure(®)): 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 29, 2015)
150
Original Estimated Enrollment Same as current
Actual Study Completion Date July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Kazakhstan,   Australia,   Brazil,   Czechia,   Lebanon,   Russian Federation,   Turkey,   Ukraine
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number NCT02353897
Other Study ID Numbers Y-79-52120-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ipsen
Study Sponsor Ipsen
Collaborators Not Provided
Investigators
Study Director: Ipsen Medical Director Ipsen
PRS Account Ipsen
Verification Date December 2018