Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Forehead and Frown Lines
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
1 other identifier
interventional
175
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 8, 2011
CompletedFirst Posted
Study publicly available on registry
July 12, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2012
CompletedResults Posted
Study results publicly available
November 26, 2012
CompletedApril 17, 2019
April 1, 2019
5 months
July 8, 2011
October 26, 2012
April 3, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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
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.
Day 30
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
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.
Day 30
Secondary Outcomes (3)
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
Percentage of Participants With a ≥1 Grade Improvement From Baseline by Subject-Assessed FWS in Forehead Lines at Rest
Baseline, Day 30
Study Arms (3)
botulinum toxin Type A (40 Units)
ACTIVE COMPARATORBotulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
botulinum toxin Type A (30 Units)
ACTIVE COMPARATORBotulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
placebo (Normal saline)
PLACEBO COMPARATORPlacebo (Normal saline) injected into bilateral forehead and frown line areas on Day 1.
Interventions
Botulinum toxin Type A (total dose 30 Units or 40 Units) injected into bilateral forehead and frown line areas on Day 1.
Normal Saline (placebo) injected into bilateral forehead and frown line areas on Day 1.
Eligibility Criteria
You may qualify if:
- Moderate to severe forehead lines
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
Toronto, Ontario, Canada
Related Publications (1)
Solish N, Rivers JK, Humphrey S, Muhn C, Somogyi C, Lei X, Bhogal M, Caulkins C. Efficacy and Safety of OnabotulinumtoxinA Treatment of Forehead Lines: A Multicenter, Randomized, Dose-Ranging Controlled Trial. Dermatol Surg. 2016 Mar;42(3):410-9. doi: 10.1097/DSS.0000000000000626.
PMID: 26863598BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President Medical Affairs,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2011
First Posted
July 12, 2011
Study Start
June 1, 2011
Primary Completion
October 18, 2011
Study Completion
February 28, 2012
Last Updated
April 17, 2019
Results First Posted
November 26, 2012
Record last verified: 2019-04