Phase 3 N=391 Randomized Double-blind Treatment

A Safety and Efficacy Study of OnabotulinumtoxinA in Forehead and Glabellar Facial Rhytides

Forehead Rhytides · Glabellar Rhytides

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View on ClinicalTrials.gov: NCT02261467 ↗

Enrolled (actual)

391

Serious AEs

1.1%

Results posted

Jun 2017

Primary outcome: 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 — 0.0; 61.4 Percentage of Subjects

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: OnabotulinumtoxinA (Biological); Normal Saline (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Jun 2015

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	0.0; 61.4	—
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	2.0; 94.1	—
SECONDARY Percentage of Subjects With ≥1-Grade Improvement From Baseline on the Investigator's FWS Rating of Forehead Line Severity at Rest	19.8; 85.6	—
SECONDARY Percentage of Subjects Reporting Mostly Satisfied or Very Satisfied on the 5-Point Facial Line Satisfaction Questionnaire (FLSQ) Item 5	1.0; 90.3	—
SECONDARY Percentage of Subjects With ≥20-Point Improvement From Baseline on the Impact Domain of the FLSQ Among Subjects With Baseline Score ≥ 20 Points	18.9; 73.9	—
SECONDARY Percentage of Subjects With a ≥3-Point Improvement From Baseline on Item 4 of the 11-Point Facial Line Outcomes (FLO-11) Questionnaire©	11.2; 77.2	—
SECONDARY Time to Retreatment Eligibility	119	—

Summary

This is a safety and efficacy study of onabotulinumtoxinA in subjects with forehead and glabellar facial rhytides (frown lines).

Eligibility Criteria

Inclusion Criteria

Moderate to severe forehead and glabellar 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02261467). 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.