Phase 3
Completed N=787
A Safety and Efficacy Study of OnabotulinumtoxinA in Upper Facial Rhytides
Facial Rhytides · Glabellar Rhytides
Source: ClinicalTrials.gov NCT02261493 ↗
Enrolled (actual)
787
Serious AEs
2.1%
Results posted
Jul 2017
Primary outcomePrimary: Percentage of Subjects With ≥2-Grade Improvement From Baseline on Both the Investigator's and Subject's Facial Wrinkle Scale (FWS) Ratings of Forehead Line Severity at Maximum Eyebrow Elevation — 0.6; 45.6; 53.0 Percentage of Subjects
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is a safety and efficacy study of onabotulinumtoxinA in subjects with upper facial rhytides (forehead lines, glabellar lines, lateral canthal lines [crow's feet lines]).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With ≥2-Grade Improvement From Baseline on Both the Investigator's and Subject's Facial Wrinkle Scale (FWS) Ratings of Forehead Line Severity at Maximum Eyebrow Elevation |
0.6; 45.6; 53.0 | — |
| SECONDARY Percentage of Subjects With an Investigator Rating of None or Mild on the 4-Grade FWS for Forehead Line Severity at Maximum Eyebrow Elevation |
3.8; 90.3; 94.9 | — |
| SECONDARY Percentage of Subjects With ≥1-Grade Improvement From Baseline on the Investigator's FWS Rating of Forehead Line Severity at Rest |
18.7; 85.2; 84.8 | — |
| SECONDARY Percentage of Subjects Reporting Mostly Satisfied or Very Satisfied on the 5-Point Facial Line Satisfaction Questionnaire (FLSQ) Item 5 |
3.2; 81.4; 87.9 | — |
| SECONDARY Percentage of Subjects With ≥20-Point Improvement From Baseline on the Impact Domain of the FLSQ Among Subjects With Baseline Score ≥ 20 Points |
19.7; 61.0; 76.1 | — |
| SECONDARY Percentage of Subjects With a ≥3-Point Improvement From Baseline on Item 4 of the 11-Point Facial Line Outcomes (FLO-11) Questionnaire© |
9.9; 66.7; 77.1 | — |
| SECONDARY Time to Retreatment Eligibility |
64.0; 120.0; 126.0 | — |
Eligibility Criteria
Inclusion Criteria
- Moderate to severe forehead lines, glabellar lines, and crow's feet lines
- Willing to have facial photos taken
Exclusion Criteria
- Prior exposure to botulinum toxin of any serotype for any indication
- Anticipated need for treatment with botulinum toxin of any serotype for any indication during the study, other than study treatment
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
- Any facial resurfacing laser or light treatment, microdermabrasion, or superficial peels in the past 3 months
- Any medium depth or deep depth facial chemical peels; facial skin resurfacing; or permanent facial make-up in the past 6 months
- Any nonpermanent soft tissue fillers, or treatment with oral retinoids in the past year - Prior face lift, thread lift, eyebrow lift, or related procedures (eg, eyelid and/or eyebrow surgery)
- Prior facial treatment with permanent soft tissue fillers, synthetic implants (eg, Gore-Tex®), and/or fat transplantation
Data sourced from ClinicalTrials.gov (NCT02261493). 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. Informational only — not medical advice.