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

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ClinicalTrials.gov Identifier: NCT01777620
Recruitment Status : Completed
First Posted : January 29, 2013
Results First Posted : May 30, 2014
Last Update Posted : May 30, 2014
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Facial Rhytides
Interventions Biological: onabotulinumtoxinA
Drug: Normal Saline
Enrollment 125
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BOTOX® Placebo
Hide Arm/Group Description BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1. Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
Period Title: Overall Study
Started 63 62
Completed 62 62
Not Completed 1 0
Reason Not Completed
Subject Withdrawal             1             0
Arm/Group Title BOTOX® Placebo Total
Hide Arm/Group Description BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1. Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 60 57 117
Hide Baseline Analysis Population Description
Baseline measures are based on the Per-Protocol population that included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 57 participants 117 participants
< 45 years 25 24 49
45 – 65 years 35 33 68
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 57 participants 117 participants
Female
48
  80.0%
50
  87.7%
98
  83.8%
Male
12
  20.0%
7
  12.3%
19
  16.2%
1.Primary Outcome
Title Percentage of Participants Satisfied With Treatment of Glabellar Lines Assessed Using the Facial Line Satisfaction Questionnaire (FLSQ)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
Arm/Group Title BOTOX® Placebo
Hide Arm/Group Description:
BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
Overall Number of Participants Analyzed 60 57
Measure Type: Number
Unit of Measure: Percentage of participants
81.7 0.0
2.Secondary Outcome
Title Percentage of Participants Satisfied With Treatment of Crow’s Feet Lines (CFL) and Glabellar Lines Assessed Using the FLSQ
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
Arm/Group Title BOTOX® Placebo
Hide Arm/Group Description:
BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
Overall Number of Participants Analyzed 60 57
Measure Type: Number
Unit of Measure: Percentage of participants
81.7 0.0
3.Secondary Outcome
Title Percentage of Participants Satisfied With Duration of Treatment of Glabellar Lines Assessed Using the FLSQ
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
Arm/Group Title BOTOX® Placebo
Hide Arm/Group Description:
BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
Overall Number of Participants Analyzed 60 57
Measure Type: Number
Unit of Measure: Percentage of participants
65.0 0.0
4.Secondary Outcome
Title Percentage of Participants Where Treatment of Glabellar Lines Met Expectation Assessed Using the FLSQ
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
Arm/Group Title BOTOX® Placebo
Hide Arm/Group Description:
BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
Overall Number of Participants Analyzed 60 57
Measure Type: Number
Unit of Measure: Percentage of participants
88.3 14.0
5.Secondary Outcome
Title Percentage of Participants Satisfied With Duration of Treatment of CFL and Glabellar Lines Assessed Using the FLSQ
Hide Description 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.
Time Frame Day 90
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
Arm/Group Title BOTOX® Placebo
Hide Arm/Group Description:
BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
Overall Number of Participants Analyzed 60 57
Measure Type: Number
Unit of Measure: Percentage of participants
61.7 0.0
6.Secondary Outcome
Title Percentage of Participants Where Treatment of CFL and Glabellar Lines Met Expectation Assessed Using the FLSQ
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
Arm/Group Title BOTOX® Placebo
Hide Arm/Group Description:
BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
Overall Number of Participants Analyzed 60 57
Measure Type: Number
Unit of Measure: Percentage of participants
86.7 15.8
7.Secondary Outcome
Title Percentage of Participants Who Were Likely to Continue Treatment of Glabellar Lines Assessed Using the FLSQ
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
Arm/Group Title BOTOX® Placebo
Hide Arm/Group Description:
BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
Overall Number of Participants Analyzed 60 57
Measure Type: Number
Unit of Measure: Percentage of participants
78.3 36.8
8.Secondary Outcome
Title Percentage of Participants Who Were Likely to Continue Treatment of CFL and Glabellar Lines Assessed Using the FLSQ
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
Arm/Group Title BOTOX® Placebo
Hide Arm/Group Description:
BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
Overall Number of Participants Analyzed 60 57
Measure Type: Number
Unit of Measure: Percentage of participants
78.3 31.6
9.Secondary Outcome
Title 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
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
Arm/Group Title BOTOX® Placebo
Hide Arm/Group Description:
BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
Overall Number of Participants Analyzed 60 57
Measure Type: Number
Unit of Measure: Percentage of participants
83.3 1.8
10.Secondary Outcome
Title 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
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
Arm/Group Title BOTOX® Placebo
Hide Arm/Group Description:
BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
Overall Number of Participants Analyzed 60 57
Measure Type: Number
Unit of Measure: Percentage of participants
86.7 8.8
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BOTOX® Placebo
Hide Arm/Group Description BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1. Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
All-Cause Mortality
BOTOX® Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
BOTOX® Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/63 (1.59%)   0/62 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Squamous cell carcinoma  1  1/63 (1.59%)  0/62 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BOTOX® Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   6/63 (9.52%)   4/62 (6.45%) 
Nervous system disorders     
Headache * 1  6/63 (9.52%)  4/62 (6.45%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Vice President Medical Affairs,
Organization: Allergan, Inc
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01777620     History of Changes
Other Study ID Numbers: GMA-BTXC-12-001
First Submitted: January 25, 2013
First Posted: January 29, 2013
Results First Submitted: May 2, 2014
Results First Posted: May 30, 2014
Last Update Posted: May 30, 2014