NCT01777620

A Study of Subject Satisfaction With BOTOX® Cosmetic Treatment in Facial Rhytides

Completed Phase 4 Results posted Last updated 17 April 2019

What this trial tests

Phase 4 trial testing onabotulinumtoxinA in Facial Rhytides in 125 participants. Completed in 31 July 2013.

Timeline

31 January 2013

Primary endpoint
29 May 2013

31 July 2013

Quick facts

Lead sponsor	Allergan
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	125
Start date	31 January 2013
Primary completion	29 May 2013
Estimated completion	31 July 2013
Sites	1 location across Canada

Drugs / interventions tested

• onabotulinumtoxinA (ONABOTULINUMTOXINA) — full drug profile →
• Normal Saline

Conditions studied

• Facial Rhytides — all drugs for Facial Rhytides →

Sponsor

Allergan — full company profile →

Who can join

Adults 18 to 65, any sex, 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.

Percentage of Participants Satisfied With Treatment of Glabellar Lines Assessed Using the Facial Line Satisfaction Questionnaire (FLSQ) Primary · Day 60

Participants assessed their overall satisfaction with their glabellar (frown) lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants with responses mostly or very satisfied is reported.

Group	Value	95% CI
BOTOX®	81.7
Placebo	0.0

Percentage of Participants Satisfied With Treatment of Crow's Feet Lines (CFL) and Glabellar Lines Assessed Using the FLSQ Secondary · Day 60

Participants assessed their overall satisfaction with both their CFL and glabellar lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants mostly or very satisfied is reported.

Group	Value	95% CI
BOTOX®	81.7
Placebo	0.0

Percentage of Participants Satisfied With Duration of Treatment of Glabellar Lines Assessed Using the FLSQ Secondary · Day 90

Participants assessed their overall satisfaction with duration of treatment of glabellar lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants with responses mostly or very satisfied is reported.

Group	Value	95% CI
BOTOX®	65.0
Placebo	0.0

Percentage of Participants Where Treatment of Glabellar Lines Met Expectation Assessed Using the FLSQ Secondary · Day 60

Participants assessed whether treatment of their glabellar lines met expectation using the FLSQ 3-point scale where: 1=Worse than expected, 2=Met expectations and 3=Better than expected. The percentage of participants with responses Met expectations and Better than expected is reported.

Group	Value	95% CI
BOTOX®	88.3
Placebo	14.0

Percentage of Participants Satisfied With Duration of Treatment of CFL and Glabellar Lines Assessed Using the FLSQ Secondary · Day 90

Participants assessed their overall satisfaction with duration of treatment of both CFL and glabellar lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants with responses mostly or very satisfied is reported.

Group	Value	95% CI
BOTOX®	61.7
Placebo	0.0

Percentage of Participants Where Treatment of CFL and Glabellar Lines Met Expectation Assessed Using the FLSQ Secondary · Day 60

Participants assessed whether treatment of glabellar lines met expectations using the FLSQ 3-point scale where: 1=Worse than expected, 2=Met expectations and 3=Better than expected. The percentage of participants with responses Met expectations and Better than expected is reported.

Group	Value	95% CI
BOTOX®	86.7
Placebo	15.8

Percentage of Participants Who Were Likely to Continue Treatment of Glabellar Lines Assessed Using the FLSQ Secondary · Day 90

Participants assessed how likely they were to continue treatment of glabellar Lines using the FLSQ 5-point scale where: 1=Not at all, 2=A little bit, 3=Moderately, 4=Quite a bit and 5=Extremely. The percentage of participants with responses Moderately, Quite a bit and Extremely is reported.

Group	Value	95% CI
BOTOX®	78.3
Placebo	36.8

Percentage of Participants Who Were Likely to Continue Treatment of CFL and Glabellar Lines Assessed Using the FLSQ Secondary · Day 90

Participants assessed how likely they were to continue treatment of CFL and glabellar Lines using the FLSQ 5-point scale where: 1=Not at all, 2=A little bit, 3=Moderately, 4=Quite a bit and 5=Extremely. The percentage of participants with responses Moderately, Quite a bit and Extremely is reported.

Group	Value	95% CI
BOTOX®	78.3
Placebo	31.6

Percentage of Participants With a Score of None or Mild in the Investigator's Assessment of the Severity of Glabellar Lines at Maximum Frown Assessed Using the FWS Secondary · Day 30

The Investigator assessed the severity of the patient's glabellar lines at maximum frown using the 4-point Facial Wrinkle Scale (FWS) where: 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of participants with a score of none or mild is reported.

Group	Value	95% CI
BOTOX®	83.3
Placebo	1.8

Percentage of Participants With at Least a 1-Grade Improvement in the Investigator's Assessment of the Severity of CFL at Maximum Smile Assessed Using the FWS Secondary · Baseline, Day 30

The Investigator assessed the severity of the patient's CFL at maximum smile using the 4-point FWS where: 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of participants with at least a 1-Grade improvement from Baseline is reported.

Group	Value	95% CI
BOTOX®	86.7
Placebo	8.8

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BOTOX®

Serious: 1/63 (2%)

Deaths: —

Placebo

Serious: 0/62 (0%)

Deaths: —

Serious adverse events (1 terms)

Reaction	System	BOTOX®	Placebo
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	BOTOX®	Placebo
Headache	Nervous system disorders	—	—

Most-reported serious reactions: Squamous cell carcinoma.

Data from ClinicalTrials.gov NCT01777620 adverse events section.

Sponsor's own description

This is a safety and efficacy study of BOTOX® in subjects with facial rhytides (glabellar lines and crow's feet lines).

Publications & conference data

2 peer-reviewed publications 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
2. Botulinum toxin type A for facial wrinkles.
   Camargo CP, Xia J, Costa CS, Gemperli R, et al · · 2021 · cited 21× · PMID 34224576 · DOI 10.1002/14651858.cd011301.pub2