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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02353897




Registration number
NCT02353897
Ethics application status
Date submitted
29/01/2015
Date registered
3/02/2015
Date last updated
5/11/2020

Titles & IDs
Public title
Patient and Physician's Satisfaction After a Long Term Treatment of Glabellar Lines With Dysport®
Scientific title
An Assessment of Patient and Physician's Satisfaction After a Long Term Treatment of Glabellar Lines With Dysport®.
Secondary ID [1] 0 0
Y-79-52120-201
Universal Trial Number (UTN)
Trial acronym
APPEAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glabellar Lines 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess patient satisfaction regarding GL after three injection cycles of Dysport.
Timepoint [1] 0 0
Within 3 weeks ±7 days of visit 3
Secondary outcome [1] 0 0
To describe patient individual expectations.
Timepoint [1] 0 0
Within 3 weeks ±7 days of visit 1 and 2
Secondary outcome [2] 0 0
To assess patient satisfaction after one and two injection cycles of Dysport.
Timepoint [2] 0 0
Within 3 weeks ±7 days of visit 1 and 2
Secondary outcome [3] 0 0
To describe factors associated with patient satisfaction such as attractiveness, self-esteem, self-perceived age, desire to receive another injection.
Timepoint [3] 0 0
Within 3 weeks ±7 days of visit 1 and 2
Secondary outcome [4] 0 0
To assess the GL severity (at rest and maximum frown) as per usual practice.
Timepoint [4] 0 0
Baseline (visit 1) and visit 3
Secondary outcome [5] 0 0
To assess physician satisfaction after one and three injection cycles of Dysport.
Timepoint [5] 0 0
Visit 1 follow up visit and visit 3 follow up visit (if performed)
Secondary outcome [6] 0 0
To describe Dysport injection practices: muscles injected, total injected units, total volume injected, number of injection points and interval between injections.
Timepoint [6] 0 0
From visit 1 until the end of the study

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2016
Sample size
Target
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
ERASE - Malvern
Recruitment hospital [2] 0 0
SouthDerm - Sydney
Recruitment postcode(s) [1] 0 0
3144 - Malvern
Recruitment postcode(s) [2] 0 0
2217 - Sydney
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Botucatu
Country [2] 0 0
Czechia
State/province [2] 0 0
Brno
Country [3] 0 0
Czechia
State/province [3] 0 0
Praha
Country [4] 0 0
Kazakhstan
State/province [4] 0 0
Almaty
Country [5] 0 0
Lebanon
State/province [5] 0 0
Beirut
Country [6] 0 0
Russian Federation
State/province [6] 0 0
Moscow
Country [7] 0 0
Russian Federation
State/province [7] 0 0
Novosibirsk
Country [8] 0 0
Russian Federation
State/province [8] 0 0
St Petersburg
Country [9] 0 0
Turkey
State/province [9] 0 0
Kocaeli
Country [10] 0 0
Ukraine
State/province [10] 0 0
Kyiv

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ipsen
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02353897
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Ipsen Medical Director
Address 0 0
Ipsen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02353897