NCT01608659

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

Completed Results posted Last updated 17 April 2019

What this trial tests

trial testing botulinum toxin Type A in Facial Rhytides in 110 participants. Completed in 17 June 2011.

Timeline

1 April 2011

Primary endpoint
17 June 2011

17 June 2011

Quick facts

Lead sponsor	Allergan
Status	Completed
Study type	OBSERVATIONAL
Enrollment	110
Start date	1 April 2011
Primary completion	17 June 2011
Estimated completion	17 June 2011
Sites	1 location across Argentina

Drugs / interventions tested

• botulinum toxin Type A (BOTULINUM TOXIN TYPE A) — full drug profile →

Conditions studied

• Facial Rhytides — all drugs for Facial Rhytides →

Sponsor

Allergan — full company profile →

Who can join

18 and older, female only, with Facial Rhytides. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Average Total Dose Per Treatment Period Primary · 24 Months

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

Treatment Period 1 (BOTOX®) N=34

Group	Value	95% CI
Botulinum Toxin Type A	49.2	± 12.77

Treatment Period 2 (Xeomin®) N=34

Group	Value	95% CI
Botulinum Toxin Type A	48.1	± 15.18

Treatment Period 3 (BOTOX®) N=16

Group	Value	95% CI
Botulinum Toxin Type A	45.8	± 4.68

Inter-Injection Interval Duration of Each Treatment Period Secondary · 24 Months

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

Treatment Period 1 (BOTOX®) N=110

Group	Value	95% CI
Botulinum Toxin Type A	180.3	58 – 623

Treatment Period 2 (Xeomin®) N=106

Group	Value	95% CI
Botulinum Toxin Type A	144.3	13 – 658

Treatment Period 3 (BOTOX®) N=76

Group	Value	95% CI
Botulinum Toxin Type A	176.9	98 – 639

Percent of Subjects Reporting Satisfaction With Treatment Effects Secondary · 24 Months

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

Treatment Period 1 (BOTOX®) N=80

Group	Value	95% CI
Botulinum Toxin Type A	99.0	± 6.68

Treatment Period 2 (Xeomin®) N=74

Group	Value	95% CI
Botulinum Toxin Type A	33.7	± 39.29

Treatment Period 3 (BOTOX®) N=67

Group	Value	95% CI
Botulinum Toxin Type A	90.3	± 17.56

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Neurotoxin Impurities: A Review of Threats to Efficacy.
   Park JY, Sunga O, Wanitphakdeedecha R, Frevert J. · · 2020 · cited 27× · PMID 32095419 · DOI 10.1097/gox.0000000000002627