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

Facial Rhytides Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01777620
• Other study ID #: GMA-BTXC-12-001
• Status: Completed
• Phase: Phase 4
• Start date: January 31, 2013
• Est. completion date: July 31, 2013

Study information

• Verified date: April 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: July 31, 2013
• Est. primary completion date: May 29, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Facial Rhytides

Intervention

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

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Rivers JK, Bertucci V, McGillivray W, Muhn C, Rosen N, Solish N, Weichman BM, Wheeler S, Daniels SR, Gallagher CJ. Subject satisfaction with onabotulinumtoxinA treatment of glabellar and lateral canthal lines using a new patient-reported outcome measure. Dermatol Surg. 2015 Aug;41(8):950-9. doi: 10.1097/DSS.0000000000000424. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 60
Secondary	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.	Day 60
Secondary	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.	Day 90
Secondary	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.	Day 60
Secondary	Percentage of Participants Satisfied With Duration of Treatment of CFL and Glabellar Lines Assessed Using the FLSQ	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.	Day 90
Secondary	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.	Day 60
Secondary	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.	Day 90
Secondary	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.	Day 90
Secondary	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.	Day 30
Secondary	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.	Baseline, Day 30