Phase 4
N=125
A Study of Subject Satisfaction With BOTOX® Cosmetic Treatment in Facial Rhytides
Facial Rhytides
Bottom Line
View on ClinicalTrials.gov: NCT01777620 ↗Enrolled (actual)
125
Serious AEs
0.8%
Results posted
May 2014
Primary outcome: Primary: Percentage of Participants Satisfied With Treatment of Glabellar Lines Assessed Using the Facial Line Satisfaction Questionnaire (FLSQ) — 81.7; 0.0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- onabotulinumtoxinA (Biological); Normal Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Satisfied With Treatment of Glabellar Lines Assessed Using the Facial Line Satisfaction Questionnaire (FLSQ) |
81.7; 0.0 | — |
| SECONDARY Percentage of Participants Satisfied With Treatment of Crow's Feet Lines (CFL) and Glabellar Lines Assessed Using the FLSQ |
81.7; 0.0 | — |
| SECONDARY Percentage of Participants Satisfied With Duration of Treatment of Glabellar Lines Assessed Using the FLSQ |
65.0; 0.0 | — |
| SECONDARY Percentage of Participants Where Treatment of Glabellar Lines Met Expectation Assessed Using the FLSQ |
88.3; 14.0 | — |
| SECONDARY Percentage of Participants Satisfied With Duration of Treatment of CFL and Glabellar Lines Assessed Using the FLSQ |
61.7; 0.0 | — |
| SECONDARY Percentage of Participants Where Treatment of CFL and Glabellar Lines Met Expectation Assessed Using the FLSQ |
86.7; 15.8 | — |
| SECONDARY Percentage of Participants Who Were Likely to Continue Treatment of Glabellar Lines Assessed Using the FLSQ |
78.3; 36.8 | — |
| SECONDARY Percentage of Participants Who Were Likely to Continue Treatment of CFL and Glabellar Lines Assessed Using the FLSQ |
78.3; 31.6 | — |
| 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 |
83.3; 1.8 | — |
| 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 |
86.7; 8.8 | — |
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)
Data sourced from ClinicalTrials.gov (NCT01777620). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.