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Efficacy and Safety of a New Dilution and Injection Volume of AbobotulinumtoxinA for the Treatment of Glabellar Lines

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a New Dilution and Injection Volume of AbobotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03960957
Enrollment
301
Registered
2019-05-23
Start date
2019-06-17
Completion date
2020-04-16
Last updated
2022-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glabellar Frown Lines

Brief summary

An interventional phase 3 study to evaluate efficacy and safety of a new dilution and injection volume of AbobotulinumtoxinA treatment for glabellar lines

Interventions

BIOLOGICALAbobotulinumtoxinA

Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA

OTHERPlacebo

Treatment of glabellar facial lines with placebo

Sponsors

Galderma R&D
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Moderate to severe glabellar lines at maximum frown * Understands the study requirements and signs an informed consent form

Exclusion criteria

* Botulinum toxin treatment in the face within 6 months prior to study treatment

Design outcomes

Primary

MeasureTime frameDescription
Evaluate Composite Responder Rate at Month 1 for a Single Dose of AbobotulinumtoxinA Compared to PlaceboMonth 1 after treatmentComposite responder is defined as a subject who achieves a score of 0 or 1 and at least 2 grades improvement on both the Investigator Live Assessment (ILA) and the Subject Self Assessment (SSA)

Countries

United States

Participant flow

Participants by arm

ArmCount
Experimental
AbobotulinumtoxinA AbobotulinumtoxinA: Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA
224
Placebo
Placebo: Treatment of glabellar facial lines with placebo
77
Total301

Baseline characteristics

CharacteristicTotalPlaceboExperimental
Age, Continuous44.1 years
STANDARD_DEVIATION 11.56
42.5 years
STANDARD_DEVIATION 11.86
44.7 years
STANDARD_DEVIATION 11.43
Fitzpatrick Skin Type (FST)
FST I
5 Participants1 Participants4 Participants
Fitzpatrick Skin Type (FST)
FST II
80 Participants21 Participants59 Participants
Fitzpatrick Skin Type (FST)
FST III
147 Participants40 Participants107 Participants
Fitzpatrick Skin Type (FST)
FST IV
58 Participants13 Participants45 Participants
Fitzpatrick Skin Type (FST)
FST V
4 Participants1 Participants3 Participants
Fitzpatrick Skin Type (FST)
FST VI
7 Participants1 Participants6 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
6 Participants2 Participants4 Participants
Race (NIH/OMB)
Black or African American
11 Participants2 Participants9 Participants
Race (NIH/OMB)
More than one race
4 Participants0 Participants4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants1 Participants2 Participants
Race (NIH/OMB)
White
277 Participants72 Participants205 Participants
Region of Enrollment
United States
301 participants77 participants224 participants
Sex: Female, Male
Female
264 Participants69 Participants195 Participants
Sex: Female, Male
Male
37 Participants8 Participants29 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2230 / 77
other
Total, other adverse events
24 / 2236 / 77
serious
Total, serious adverse events
4 / 2230 / 77

Outcome results

Primary

Evaluate Composite Responder Rate at Month 1 for a Single Dose of AbobotulinumtoxinA Compared to Placebo

Composite responder is defined as a subject who achieves a score of 0 or 1 and at least 2 grades improvement on both the Investigator Live Assessment (ILA) and the Subject Self Assessment (SSA)

Time frame: Month 1 after treatment

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ExperimentalEvaluate Composite Responder Rate at Month 1 for a Single Dose of AbobotulinumtoxinA Compared to Placebo142 Participants
PlaceboEvaluate Composite Responder Rate at Month 1 for a Single Dose of AbobotulinumtoxinA Compared to Placebo0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026