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

Phase 4CompletedNCT01777620

Allergan125 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

125

Conditions

Facial Rhytides

Interventions

onabotulinumtoxinABIOLOGICAL

BOTOX® (onabotulinumtoxinA) injected into the areas of glabellar lines and crow's feet lines on Day 1.

Normal SalineDRUG

Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Glabellar lines and crow's feet lines * No prior use of botulinum toxin therapy of any serotype for any reason Exclusion Criteria: * Previous facial cosmetic surgery, tissue grafting, or tissue augmentation with silicone or fat or other permanent fillers * Planning a facial cosmetic procedure during the study period * Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, and/or amyotrophic lateral sclerosis * Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study treatment)

Locations (1)

Unnamed facility

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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

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.

Time frame: Day 60

Secondary Outcomes

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

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.

Time frame: Day 60

Percentage of Participants Satisfied With Duration of Treatment of Glabellar Lines Assessed Using the FLSQ

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.

Time frame: Day 90

Percentage of Participants Where Treatment of Glabellar Lines Met Expectation Assessed Using the FLSQ

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.

Time frame: Day 60

Percentage of Participants Satisfied With Duration of Treatment of CFL and Glabellar Lines Assessed Using the FLSQ

Data from ClinicalTrials.gov

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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.

Percentage of Participants Where Treatment of CFL and Glabellar Lines Met Expectation Assessed Using the FLSQ

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.

Time frame: Day 60

Percentage of Participants Who Were Likely to Continue Treatment of Glabellar Lines Assessed Using the FLSQ

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.

Time frame: Day 90

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

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.

Time frame: Day 90

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

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.

Time frame: Day 30

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

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.

Time frame: Baseline, Day 30