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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

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.

Condition or disease
Glabellar Lines

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Assessment of Patient and Physician's Satisfaction After a Long Term Treatment of Glabellar Lines With Dysport®.
Study Start Date : October 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. To describe patient individual expectations. [ Time Frame: Within 3 weeks ±7 days of visit 1 and 2 ]
    Assessed by patient auto questionnaire completion

  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 ]
    Assessed by patient auto questionnaire completion

  3. 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

  4. 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

  5. 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

  6. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Private practices and clinics
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353897


Locations
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Australia
SouthDerm
Sydney, Australia, 2217
ERASE
Victoria, Australia, 3144
Brazil
Clinica Laura Bariquelo Buratini
Botucatu, Brazil, 18603-390
Czechia
Estetická Dermatologie
Brno, Czechia, 60200
BcD Clinic s.r.o.
Praha, Czechia, 14000
Kazakhstan
Laser Center DARUS
Almaty, Kazakhstan, 050022
Lebanon
Dr Haddad Clinics
Beirut, Lebanon, 70920
Russian Federation
Centre of Aesthetic Medicine "Chistie prudi"
Moscow, Russian Federation, 105062
Preventive Medicine Clinic "Vallex M"
Moscow, Russian Federation, 117630
Plastic Surgery Institute
Moscow, Russian Federation, 119002
FI IF & TC & apos; Eye microsurgery & apos
Novosibirsk, Russian Federation, 630071
Clinic of Aesthetic Medicine
St Petersburg, Russian Federation, 197110
Turkey
Kocaeli University School of Medecine Umuttepe
Kocaeli, Turkey, 41380
Ukraine
Clinic of Aesthetic medicine "Ankor"
Kyiv, Ukraine, 03087
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02353897     History of Changes
Other Study ID Numbers: Y-79-52120-201
First Posted: February 3, 2015    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Additional relevant MeSH terms:
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abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs