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

NCT ID: NCT02353897

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-07-31

Brief Summary

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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

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Conditions

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Glabellar Lines

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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ERASE

Malvern, , Australia

Site Status

SouthDerm

Sydney, , Australia

Site Status

Clinica Laura Bariquelo Buratini

Botucatu, , Brazil

Site Status

Estetická Dermatologie

Brno, , Czechia

Site Status

BcD Clinic s.r.o.

Prague, , Czechia

Site Status

Laser Center DARUS

Almaty, , Kazakhstan

Site Status

Dr Haddad Clinics

Beirut, , Lebanon

Site Status

Centre of Aesthetic Medicine "Chistie prudi"

Moscow, , Russia

Site Status

Preventive Medicine Clinic "Vallex M"

Moscow, , Russia

Site Status

Plastic Surgery Institute

Moscow, , Russia

Site Status

FI IF & TC & apos; Eye microsurgery & apos

Novosibirsk, , Russia

Site Status

Clinic of Aesthetic Medicine

Saint Petersburg, , Russia

Site Status

Kocaeli University School of Medecine Umuttepe

Kocaeli, , Turkey (Türkiye)

Site Status

Clinic of Aesthetic medicine "Ankor"

Kyiv, , Ukraine

Site Status

Countries

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Australia Brazil Czechia Kazakhstan Lebanon Russia Turkey (Türkiye) Ukraine

References

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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.

Reference Type DERIVED
PMID: 30120518 (View on PubMed)

Other Identifiers

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Y-79-52120-201

Identifier Type: -

Identifier Source: org_study_id