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Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Platysmal Bands

A Multicenter, Randomized, Dose-Ranging, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Moderate to Severe Platysmal Bands

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04080882
Enrollment
80
Registered
2019-09-06
Start date
2019-09-25
Completion date
2020-06-04
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

Platysmal Bands

Brief summary

Interventional phase 2 study to evaluate safety and efficacy of abobotulinumtoxinA for the treatment of platysmal bands.

Interventions

BIOLOGICALAbobotulinumtoxinA dose 3

Treatment of platysmal bands

BIOLOGICALAbobotulinumtoxinA dose 1

Treatment of platysmal bands

OTHERPlacebo

Treatment of platysmal bands

BIOLOGICALAbobotulinumtoxinA dose 2

Treatment of platysmal bands

Sponsors

Galderma R&D
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
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 platysmal bands at maximum contraction as assessed by the Investigator using a photographic scale * Platysmal bands graded as Level 3 or 4 at maximum contraction as assessed by the subject using a photographic scale

Exclusion criteria

* Botulinum toxin treatment of any serotype below the lower orbital rim, in the neck or chest within 12 months prior to study treatment

Design outcomes

Primary

MeasureTime frameDescription
Responder Rate at Month 1 for a Single Dose of abobotulinumtoxinA Compared to PlaceboMonth 1 after treatmentA responder is defined as a subject who achieves grade 1 or 2 in platysmal band severity on the Investigator Live Assessment (ILA).

Countries

United States

Participant flow

Participants by arm

ArmCount
Placebo
placebo injected into platysma bands Placebo: Treatment of platysmal bands
20
AbobotulinumtoxinA Dose 1
AbobotulinumtoxinA dose 1 injected into platysma bands AbobotulinumtoxinA dose 1: Treatment of platysmal bands
60
Total80

Baseline characteristics

CharacteristicPlaceboAbobotulinumtoxinA Dose 1Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
20 Participants60 Participants80 Participants
Age, Continuous50.6 years
STANDARD_DEVIATION 8.56
52.1 years
STANDARD_DEVIATION 7.74
51.7 years
STANDARD_DEVIATION 7.93
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants11 Participants14 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
17 Participants49 Participants66 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Fitzpatrick Skin Type (FST)
FST I
0 Participants0 Participants0 Participants
Fitzpatrick Skin Type (FST)
FST II
9 Participants17 Participants26 Participants
Fitzpatrick Skin Type (FST)
FST III
5 Participants25 Participants30 Participants
Fitzpatrick Skin Type (FST)
FST IV
4 Participants15 Participants19 Participants
Fitzpatrick Skin Type (FST)
FST V
1 Participants1 Participants2 Participants
Fitzpatrick Skin Type (FST)
FST VI
1 Participants2 Participants3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
2 Participants2 Participants4 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
18 Participants57 Participants75 Participants
Region of Enrollment
United States
20 participants60 participants80 participants
Sex: Female, Male
Female
20 Participants58 Participants78 Participants
Sex: Female, Male
Male
0 Participants2 Participants2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 200 / 60
other
Total, other adverse events
7 / 2014 / 60
serious
Total, serious adverse events
0 / 200 / 60

Outcome results

Primary

Responder Rate at Month 1 for a Single Dose of abobotulinumtoxinA Compared to Placebo

A responder is defined as a subject who achieves grade 1 or 2 in platysmal band severity on the Investigator Live Assessment (ILA).

Time frame: Month 1 after treatment

Population: Due to business decision study did not proceed to enroll dose 2 or dose 3.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PlaceboResponder Rate at Month 1 for a Single Dose of abobotulinumtoxinA Compared to Placebo3 Participants
AbobotulinumtoxinA Dose 1Responder Rate at Month 1 for a Single Dose of abobotulinumtoxinA Compared to Placebo36 Participants

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