Glabellar LinesAPPEALNCT02353897
Patient and Physician's Satisfaction After a Long Term Treatment of Glabellar Lines With Dysport®
An observational study of Glabellar Lines, run by Ipsen at 14 sites in 8 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glabellar Lines
- How many people
- 150 participants
- Where
- 14 sitesin 8 countries
- Study dates
- Oct 2014to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Private practices and clinics
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
14 sites in 8 countries.
14 sites in 8 countries
Russia5 sites
Centre of Aesthetic Medicine "Chistie prudi"
Moscow, 105062
Preventive Medicine Clinic "Vallex M"
Moscow, 117630
Plastic Surgery Institute
Moscow, 119002
FI IF & TC & apos; Eye microsurgery & apos
Novosibirsk, 630071
Clinic of Aesthetic Medicine
Saint Petersburg, 197110
Czechia2 sites
Estetická Dermatologie
Brno, 60200
BcD Clinic s.r.o.
Prague, 14000
Turkey (Türkiye)1 site
Kocaeli University School of Medecine Umuttepe
Kocaeli, 41380
About this study
Official title: An Assessment of Patient and Physician's Satisfaction After a Long Term Treatment of Glabellar Lines With Dysport®.
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.
- Conditions
- Glabellar Lines
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess patient satisfaction regarding GL after three injection cycles of Dysport.
Assessed by patient auto questionnaire completion
Measured: Within 3 weeks ±7 days of visit 3
Secondary outcomes (6)
To describe patient individual expectations.
Assessed by patient auto questionnaire completion
Measured: Within 3 weeks ±7 days of visit 1 and 2
To assess patient satisfaction after one and two injection cycles of Dysport.
Assessed by patient auto questionnaire completion
Measured: 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.
Assessed by patient auto questionnaire completion
Measured: Within 3 weeks ±7 days of visit 1 and 2
To assess the GL severity (at rest and maximum frown) as per usual practice.
Physician assessment using GL severity scale
Measured: Baseline (visit 1) and visit 3
To assess physician satisfaction after one and three injection cycles of Dysport.
5 point Likert scale
Measured: 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.
Measured: From visit 1 until the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startOct 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glabellar LinesStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353897
- Sponsor's protocol ID
- Y-79-52120-201
- Acronym
- APPEAL
- Status last verified
- Nov 2020
- First submitted
- 29 Jan 2015
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
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(R)/Azzalure(R)): 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.
PubMed 30120518
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of Patient and Physician's Satisfaction After a Long Term Treatment of Glabellar Lines With Dysport®.
- ClinicalTrials.gov ID
- NCT02353897
- Acronym / sponsor ID
- APPEAL / Y-79-52120-201
- Conditions
- Glabellar Lines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 3 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Private practices and clinics
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Derived from this study: PubMed 30120518Gubanova 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(R)/Azzalure(R)): 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
14 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glabellar Lines, run by Ipsen at 14 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Russia, Australia, Czechia, Brazil, Kazakhstan and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess patient satisfaction regarding GL after three injection cycles of Dysport. (time frame: Within 3 weeks ±7 days of visit 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02353897, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.