Safety and Efficacy Study of Botulinum Toxin for the Treatment of Glabellar Frown Lines
A Multicentre, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Three Doses of Botulinum Toxin in the Treatment of Moderate to Very Severe Glabellar Frown Lines
1 other identifier
interventional
359
1 country
8
Brief Summary
The primary objective of the study is to evaluate the efficacy in wrinkle reduction of a single treatment of three different doses of botulinum toxin compared to placebo, in the treatment of moderate to very severe glabellar frown lines.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2014
Shorter than P25 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedFirst Posted
Study publicly available on registry
September 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedAugust 26, 2022
May 1, 2016
2 months
September 1, 2014
August 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction of glabellar frown line severity on Day 14 following treatment with botulinum toxin
Reduction in glabellar frown line severity is derived separately for the Investigator and the subject assessment, using a validated photo scale, at maximum frown on Day 14.
14 Days
Study Arms (4)
Botulinum Toxin 30 units
EXPERIMENTALI.M. injection
Botulinum Toxin 45 units
EXPERIMENTALI.M. injection
Botulinum Toxin 60 units
EXPERIMENTALI.M. injection
Placebo
PLACEBO COMPARATORI.M. injection
Interventions
Eligibility Criteria
You may qualify if:
- Moderate to Very Severe glabellar lines at maximum frown as assessed by the subject and the Investigator and at least Mild glabellar lines at rest
You may not qualify if:
- Any previous treatment with any botulinum toxin
- Rhytids of the glabellar region that cannot be smoothed out by manually spreading the skin apart
- Any previous insertion of any permanent or semi-permanent material, hyaluronic acid or collagen fillers to the glabellar region
- Any history of facial surgery above the lower orbital rim
- Any planned facial surgery or aesthetic procedure during the study period
- Ablative skin resurfacing or chemical peels above the lower orbital rim in the previous 12 months or during the study period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (8)
Private practice
Birmingham, Alabama, United States
Private practice
Mobile, Alabama, United States
Private practice
San Diego, California, United States
Private practice
Englewood, Colorado, United States
Private practice
Aventura, Florida, United States
Private practice
Nashville, Tennessee, United States
Private practice
San Antonio, Texas, United States
Private practice
Salt Lake City, Utah, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2014
First Posted
September 10, 2014
Study Start
September 1, 2014
Primary Completion
November 1, 2014
Study Completion
May 1, 2015
Last Updated
August 26, 2022
Record last verified: 2016-05