Clinical trial NCT01777620: A Study of Subject Satisfaction With BOTOX® Cosmetic Treatment in Facial Rhytides
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Facial Rhytides
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-01-29
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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)

Primary outcomes:
measure: Percentage of Participants Satisfied With Treatment of Glabellar Lines Assessed Using the Facial Line Satisfaction Questionnaire (FLSQ)
timeFrame: Day 60
Secondary outcomes:
measure: Percentage of Participants Satisfied With Treatment of Crow's Feet Lines (CFL) and Glabellar Lines Assessed Using the FLSQ
timeFrame: Day 60
measure: Percentage of Participants Satisfied With Duration of Treatment of Glabellar Lines Assessed Using the FLSQ
timeFrame: Day 90
measure: Percentage of Participants Where Treatment of Glabellar Lines Met Expectation Assessed Using the FLSQ
timeFrame: Day 60
measure: Percentage of Participants Satisfied With Duration of Treatment of CFL and Glabellar Lines Assessed Using the FLSQ
timeFrame: Day 90
measure: Percentage of Participants Where Treatment of CFL and Glabellar Lines Met Expectation Assessed Using the FLSQ
timeFrame: Day 60
measure: Percentage of Participants Who Were Likely to Continue Treatment of Glabellar Lines Assessed Using the FLSQ
timeFrame: Day 90
measure: Percentage of Participants Who Were Likely to Continue Treatment of CFL and Glabellar Lines Assessed Using the FLSQ
timeFrame: Day 90
measure: 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
timeFrame: Day 30
measure: 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
timeFrame: Baseline, Day 30
Other outcomes:
Locations:
city: Toronto
country: Canada
state: Ontario
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.