An Observational Retrospective Study to Evaluate Treatment Patterns of Botulinum Toxin Type A

April 3, 2019 updated by: Allergan
This is a retrospective chart review to evaluate treatment patterns of botulinum toxin Type A for the treatment of facial lines.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Subjects treated for glabellar lines (hyperfunctional facial lines) with botulinum toxin Type A

Description

Inclusion Criteria:

  • Previously treated for glabellar lines (hyperfunctional facial lines) with botulinum toxin Type A preparation
  • Received 2 treatment cycles wtih botulinum toxin Type A (BOTOX®) prior to at least 1 treatment with botulinum toxin Type A (Xeomin®)

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
botulinum toxin Type A
Previous treatment with botulinum toxin Type A for treatment of facial lines
Drug: botulinum toxin Type A
Previous treatment with botulinum toxin Type A for treatment of facial lines
Other Names:
  • BOTOX®
  • Xeomin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Total Dose Per Treatment Period
Time Frame: 24 Months
Average total dose per treatment period was defined as total treatment dose plus total touch-up dose plus total follow-up dose.
24 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inter-Injection Interval Duration of Each Treatment Period
Time Frame: 24 Months
Inter-injection interval duration of each treatment period. Duration is defined as the number of days of an injection cycle.
24 Months
Percent of Subjects Reporting Satisfaction With Treatment Effects
Time Frame: 24 Months
Percent of subjects reporting satisfaction with treatment effects per chart notes.
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2011

Primary Completion (ACTUAL)

June 17, 2011

Study Completion (ACTUAL)

June 17, 2011

Study Registration Dates

First Submitted

May 29, 2012

First Submitted That Met QC Criteria

May 29, 2012

First Posted (ESTIMATE)

May 31, 2012

Study Record Updates

Last Update Posted (ACTUAL)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMA-BTXC-10-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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