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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02261467
• Date of registration: 03/10/2014
• Prospective Registration: Yes
• Primary sponsor: Allergan
• Public title: A Safety and Efficacy Study of OnabotulinumtoxinA in Forehead and Glabellar Facial Rhytides
• Scientific title: Evaluation of the Safety and Efficacy of Treatment With BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for Subjects With Forehead and Glabellar Facial Rhytides
• Date of first enrolment: October 21, 2014
• Target sample size: 421
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02261467
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Canada, Ireland, United States

Contacts

• Name: Medical Director
• Affiliation: Allergan

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Glabellar Rhytides

Forehead Rhytides

Intervention(s)

Biological: OnabotulinumtoxinA

Drug: Normal Saline

Primary Outcome(s)

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 [Time Frame: Baseline, Day 30]

Secondary Outcome(s)

Percentage of Subjects With =20-Point Improvement From Baseline on the Impact Domain of the FLSQ Among Subjects With Baseline Score = 20 Points [Time Frame: Baseline, Day 30]

Percentage of Subjects Reporting Mostly Satisfied or Very Satisfied on the 5-Point Facial Line Satisfaction Questionnaire (FLSQ) Item 5 [Time Frame: Day 60]

Percentage of Subjects With an Investigator Rating of None or Mild on the 4-Grade FWS for Forehead Line Severity at Maximum Eyebrow Elevation [Time Frame: Day 30]

Percentage of Subjects With =1-Grade Improvement From Baseline on the Investigator's FWS Rating of Forehead Line Severity at Rest [Time Frame: Baseline, Day 30]

Time to Retreatment Eligibility [Time Frame: 12 Months]

Percentage of Subjects With a =3-Point Improvement From Baseline on Item 4 of the 11-Point Facial Line Outcomes (FLO-11) Questionnaire© [Time Frame: Baseline, Day 30]

Secondary ID(s)

191622-142

2014-001860-36

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/06/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02261467