CClinicalTrials.gg
CompletedNCT01608659Updated Apr 17, 2019Results posted

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

An observational study in Facial Rhytides, sponsored by Allergan. Completed at 1 site in Argentina. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-17.

Sponsored by Allergan · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
110
Ages
18 Years and older
Sex
Female
01

Study summary

This is a retrospective chart review to evaluate treatment patterns of botulinum toxin Type A for the treatment of facial lines.

02

Conditions studied

  • Facial Rhytides
03

In context

Lead sponsor

Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • None
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
110 participants (actual)

Groups and cohorts

  • botulinum toxin Type A

    Previous treatment with botulinum toxin Type A for treatment of facial lines

    Drug: botulinum toxin Type A

Interventions

  • Drugbotulinum toxin Type A

    Previous treatment with botulinum toxin Type A for treatment of facial lines

    Also known as: BOTOX®, Xeomin®

06

What researchers measure

Primary outcomes

  1. Average Total Dose Per Treatment Period

    Average total dose per treatment period was defined as total treatment dose plus total touch-up dose plus total follow-up dose.

    Time frame: 24 Months

Secondary outcomes

  1. Inter-Injection Interval Duration of Each Treatment Period

    Inter-injection interval duration of each treatment period. Duration is defined as the number of days of an injection cycle.

    Time frame: 24 Months

  2. Percent of Subjects Reporting Satisfaction With Treatment Effects

    Percent of subjects reporting satisfaction with treatment effects per chart notes.

    Time frame: 24 Months

07

Results

Posted Aug 1, 2012

Participant flow

Participant flow — Overall Study
MilestoneBotulinum Toxin Type A
Started110
Completed94
Not completed16

Outcome measures

PrimaryAverage Total Dose Per Treatment Period

Average total dose per treatment period was defined as total treatment dose plus total touch-up dose plus total follow-up dose.

Time frame:
24 Months
Reported as:
Mean · Units
Average Total Dose Per Treatment Period
UnitsBotulinum Toxin Type A
Treatment Period 1 (BOTOX®) N=3449.2 ± 12.77
Treatment Period 2 (Xeomin®) N=3448.1 ± 15.18
Treatment Period 3 (BOTOX®) N=1645.8 ± 4.68
SecondaryInter-Injection Interval Duration of Each Treatment Period

Inter-injection interval duration of each treatment period. Duration is defined as the number of days of an injection cycle.

Time frame:
24 Months
Reported as:
Median · Days
Inter-Injection Interval Duration of Each Treatment Period
DaysBotulinum Toxin Type A
Treatment Period 1 (BOTOX®) N=110180.3 ± 94.40
Treatment Period 2 (Xeomin®) N=106144.3 ± 113.55
Treatment Period 3 (BOTOX®) N=76176.9 ± 91.43
SecondaryPercent of Subjects Reporting Satisfaction With Treatment Effects

Percent of subjects reporting satisfaction with treatment effects per chart notes.

Time frame:
24 Months
Reported as:
Mean · Percentage of Subjects
Percent of Subjects Reporting Satisfaction With Treatment Effects
Percentage of SubjectsBotulinum Toxin Type A
Treatment Period 1 (BOTOX®) N=8099.0 ± 6.68
Treatment Period 2 (Xeomin®) N=7433.7 ± 39.29
Treatment Period 3 (BOTOX®) N=6790.3 ± 17.56

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Botulinum Toxin Type A———

Baseline characteristics

Age, Customized
Age, Customized(Participants)Botulinum Toxin Type A
≥30 and <40 years5
≥40 and <50 years31
≥50 and <60 years33
≥60 years35
Missing6
Sex: Female, Male
Sex: Female, Male(Participants)Botulinum Toxin Type A
Female110
Male0
08

Study locations

1 site
  • Buenos Aires, Argentina
09

References and documents

Publications

  • Banegas RA, Farache F, Rancati A, Chain M, Gallagher CJ, Chapman MA, Caulkins CA. The South American Glabellar Experience Study (SAGE): a multicenter retrospective analysis of real-world treatment patterns following the introduction of incobotulinumtoxinA in Argentina. Aesthet Surg J. 2013 Sep 1;33(7):1039-45. doi: 10.1177/1090820X13503475. Epub 2013 Aug 29. PubMed 23990584 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01608659
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
May 31, 2012
Start date
Apr 1, 2011
Primary completion
Jun 17, 2011
Completion
Jun 17, 2011
Results posted
Aug 1, 2012
Last update
Apr 17, 2019

Study contacts

Medical Director
study director · Allergan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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