Status:
COMPLETED
A Safety and Efficacy Study of OnabotulinumtoxinA in Forehead and Glabellar Facial Rhytides
Lead Sponsor:
Allergan
Conditions:
Forehead Rhytides
Glabellar Rhytides
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a safety and efficacy study of onabotulinumtoxinA in subjects with forehead and glabellar facial rhytides (frown lines).
Eligibility Criteria
Inclusion
- Moderate to severe forehead and glabellar lines
- Willing to have facial photos taken
Exclusion
- 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
Key Trial Info
Start Date :
October 21 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2016
Estimated Enrollment :
421 Patients enrolled
Trial Details
Trial ID
NCT02261467
Start Date
October 21 2014
End Date
April 26 2016
Last Update
January 8 2019
Active Locations (16)
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1
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, United States, 35205
2
Advanced Research Associates
Glendale, Arizona, United States, 85308
3
Clinical Science Institute
Santa Monica, California, United States, 90404
4
About Skin Dermatology and DermSurgery, PC
Greenwood Village, Colorado, United States, 80111