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

• ClinicalTrials.gov Identifier: NCT01777620
• Recruitment Status: Completed
• First Posted: January 29, 2013
• Results First Posted: May 30, 2014
• Last Update Posted: April 17, 2019
• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Facial Rhytides	Biological: onabotulinumtoxinA; Drug: Normal Saline	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 125 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Actual Study Start Date: January 31, 2013
• Actual Primary Completion Date: May 29, 2013
• Actual Study Completion Date: July 31, 2013

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: BOTOX®; BOTOX® (onabotulinumtoxinA) injected into the areas of glabellar lines and crow's feet lines on Day 1.	Biological: onabotulinumtoxinA; BOTOX® (onabotulinumtoxinA) injected into the areas of glabellar lines and crow's feet lines on Day 1.; Other Names: botulinum toxin Type A; BOTOX®; BOTOX® Cosmetic
Placebo Comparator: Placebo; Placebo (normal saline) 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.

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants Satisfied With Treatment of Glabellar Lines Assessed Using the Facial Line Satisfaction Questionnaire (FLSQ) [ Time Frame: 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.

Secondary Outcome Measures :

1. Percentage of Participants Satisfied With Treatment of Crow's Feet Lines (CFL) and Glabellar Lines Assessed Using the FLSQ [ Time Frame: 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.
2. Percentage of Participants Satisfied With Duration of Treatment of Glabellar Lines Assessed Using the FLSQ [ Time Frame: 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.
3. Percentage of Participants Where Treatment of Glabellar Lines Met Expectation Assessed Using the FLSQ [ Time Frame: 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.
4. Percentage of Participants Satisfied With Duration of Treatment of CFL and Glabellar Lines Assessed Using the FLSQ [ Time Frame: 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.
5. Percentage of Participants Where Treatment of CFL and Glabellar Lines Met Expectation Assessed Using the FLSQ [ Time Frame: 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.
6. Percentage of Participants Who Were Likely to Continue Treatment of Glabellar Lines Assessed Using the FLSQ [ Time Frame: 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.
7. Percentage of Participants Who Were Likely to Continue Treatment of CFL and Glabellar Lines Assessed Using the FLSQ [ Time Frame: 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.
8. 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 [ Time Frame: 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.
9. 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 [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Locations

Canada, Ontario

Toronto, Ontario, Canada

Sponsors and Collaborators

Allergan

Investigators

• Study Director: Medical Director; Allergan

More Information

Publications:

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.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01777620
• Other Study ID Numbers: GMA-BTXC-12-001
• First Posted: January 29, 2013
• Results First Posted: May 30, 2014
• Last Update Posted: April 17, 2019
• Last Verified: April 2019

Additional relevant MeSH terms:

Facies; Disease Attributes; Pathologic Processes; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; Acetylcholine Release Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Neuromuscular Agents; Peripheral Nervous System Agents