A Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Single Treatment Cycle Study of BOTOX® Cosmetic (Botulinum Toxin Type A) Purified Neurotoxin Complex in Subjects With Forehead and Glabellar Rhytides
Overview
- Phase
- N/A
- Intervention
- botulinum toxin Type A
- Conditions
- Facial Rhytides
- Sponsor
- Allergan
- Enrollment
- 175
- Primary Endpoint
- Percentage of Participants Achieving a Score of None or Mild by Subject-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study evaluated the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of forehead lines (facial rhytides) when also administered to frown lines (glabellar rhytides).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Moderate to severe forehead lines
Exclusion Criteria
- •Current or previous botulinum toxin treatment of any serotype within one year
- •Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
- •Prior facial cosmetic surgery (e.g. prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery)
- •Facial laser or light treatment, microdermabrasion, or superficial peels within 3 months
- •Oral retinoid therapy within one year
Arms & Interventions
botulinum toxin Type A (40 Units)
Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
Intervention: botulinum toxin Type A
botulinum toxin Type A (30 Units)
Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
Intervention: botulinum toxin Type A
placebo (Normal saline)
Placebo (Normal saline) injected into bilateral forehead and frown line areas on Day 1.
Intervention: Normal Saline
Outcomes
Primary Outcomes
Percentage of Participants Achieving a Score of None or Mild by Subject-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation
Time Frame: Day 30
The patient assessed the severity of their forehead lines at maximum eyebrow elevation using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30.
Percentage of Participants Achieving a Score of None or Mild by Investigator-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation
Time Frame: Day 30
The Investigator assessed the severity of the patient's forehead lines at maximum eyebrow elevation using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30.
Secondary Outcomes
- Percentage of Participants With a ≥1 Grade Improvement From Baseline by Subject-Assessed FWS in Forehead Lines at Rest(Baseline, Day 30)
- Percentage of Participants Achieving Satisfied or Very Satisfied by Subject Assessment of Satisfaction of Appearance of Forehead Lines(Day 30)
- Percentage of Participants With a ≥1 Grade Improvement From Baseline by Investigator-Assessed FWS in Forehead Lines at Rest(Baseline, Day 30)