Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Platysmal Bands

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04080882
• Collaborator: (none)
• Enrollment: 80
• Locations: 8
• Arms: 4
• Actual Duration (Months): 8.3
• Patients Per Site: 10
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Platysmal Bands	Biological: AbobotulinumtoxinA dose 1; Other: Placebo; Biological: AbobotulinumtoxinA dose 2; Biological: AbobotulinumtoxinA dose 3	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Sep 25, 2019
• Actual Primary Completion Date: Dec 30, 2019
• Actual Study Completion Date: Jun 4, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: AbobotulinumtoxinA dose 1 AbobotulinumtoxinA dose 1 injected into platysma bands	Biological: AbobotulinumtoxinA dose 1; Treatment of platysmal bands
Placebo Comparator: placebo placebo injected into platysma bands	Other: Placebo; Treatment of platysmal bands
Active Comparator: AbobotulinumtoxinA dose 2 AbobotulinumtoxinA dose 2 injected into platysma bands	Biological: AbobotulinumtoxinA dose 2; Treatment of platysmal bands
Active Comparator: AbobotulinumtoxinA dose 3 AbobotulinumtoxinA dose 3 injected into platysma bands	Biological: AbobotulinumtoxinA dose 3; Treatment of platysmal bands

Outcome Measures

Primary Outcome Measures

1. Responder Rate at Month 1 for a Single Dose of abobotulinumtoxinA Compared to Placebo [Month 1 after treatment]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Galderma Research Site	Encinitas	California	United States	92024
2	Galderma Research Site	Encino	California	United States	91436
3	Galderma Research Site	Boynton Beach	Florida	United States	33472
4	Galderma Research Site	Miami	Florida	United States	33137
5	Galderma Research Site	New Orleans	Louisiana	United States	70115
6	Galderma Research Site	New Orleans	Louisiana	United States	70130
7	Galderma Research Site	Baltimore	Maryland	United States	21208
8	Galderma Research Site	New York	New York	United States	10028

Sponsors and Collaborators

• Galderma R&D

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Aug 9, 2019
• Statistical Analysis Plan - Dec 23, 2019

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT04080882
• Other Study ID Numbers: 43USD1804
• First Posted: Sep 6, 2019
• Last Update Posted: Jan 22, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: abobotulinumtoxinA; Botulinum Toxins, Type A

Study Results

Participant Flow

Arm/Group Title	Placebo	AbobotulinumtoxinA Dose 1
Arm/Group Description	placebo injected into platysma bands Placebo: Treatment of platysmal bands	AbobotulinumtoxinA dose 1 injected into platysma bands AbobotulinumtoxinA dose 1: Treatment of platysmal bands
Period Title: Overall Study
STARTED	20	60
COMPLETED	18	58
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Placebo	AbobotulinumtoxinA Dose 1	Total
Arm/Group Description	placebo injected into platysma bands Placebo: Treatment of platysmal bands	AbobotulinumtoxinA dose 1 injected into platysma bands AbobotulinumtoxinA dose 1: Treatment of platysmal bands	Total of all reporting groups
Overall Participants	20	60	80
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	20 100%	60 100%	80 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.6 (8.56)	52.1 (7.74)	51.7 (7.93)
Sex: Female, Male (Count of Participants)
Female	20 100%	58 96.7%	78 97.5%
Male	0 0%	2 3.3%	2 2.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 15%	11 18.3%	14 17.5%
Not Hispanic or Latino	17 85%	49 81.7%	66 82.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 1.7%	1 1.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 10%	2 3.3%	4 5%
White	18 90%	57 95%	75 93.8%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	20 100%	60 100%	80 100%
Fitzpatrick Skin Type (FST) (Count of Participants)
FST I	0 0%	0 0%	0 0%
FST II	9 45%	17 28.3%	26 32.5%
FST III	5 25%	25 41.7%	30 37.5%
FST IV	4 20%	15 25%	19 23.8%
FST V	1 5%	1 1.7%	2 2.5%
FST VI	1 5%	2 3.3%	3 3.8%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	AbobotulinumtoxinA Dose 1
Arm/Group Description	placebo injected into platysma bands Placebo: Treatment of platysmal bands	AbobotulinumtoxinA dose 1 injected into platysma bands AbobotulinumtoxinA dose 1: Treatment of platysmal bands
Measure Participants	20	60
Count of Participants [Participants]	3 15%	36 60%

Adverse Events

Time Frame	5 months
Adverse Event Reporting Description	Due to business decision study did not proceed to enroll dose 2 or dose 3.
Arm/Group Title	Placebo		AbobotulinumtoxinA Dose 1
Arm/Group Description	placebo injected into platysma bands Placebo: Treatment of platysmal bands		AbobotulinumtoxinA dose 1 injected into platysma bands AbobotulinumtoxinA dose 1: Treatment of platysmal bands
All Cause Mortality
	Placebo		AbobotulinumtoxinA Dose 1
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/60 (0%)
Serious Adverse Events
	Placebo		AbobotulinumtoxinA Dose 1
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/60 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		AbobotulinumtoxinA Dose 1
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/20 (35%)		14/60 (23.3%)
Eye disorders
Diplopia	1/20 (5%)	1	0/60 (0%)	0
Dry Eye	1/20 (5%)	1	0/60 (0%)	0
Gastrointestinal disorders
Dysphagia	0/20 (0%)	0	3/60 (5%)	3
Dental Caries	1/20 (5%)	1	0/60 (0%)	0
General disorders
Injection site bruising	1/20 (5%)	1	5/60 (8.3%)	5
Injection site heamorrhage	0/20 (0%)	0	3/60 (5%)	3
Injection site swelling	1/20 (5%)	1	0/60 (0%)	0
Malaise	1/20 (5%)	1	0/60 (0%)	0
Infections and infestations
Viral upper respiratory tract infectinon	1/20 (5%)	1	2/60 (3.3%)	3
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort	1/20 (5%)	1	1/60 (1.7%)	1
Nervous system disorders
Dizziness	1/20 (5%)	1	0/60 (0%)	0
Skin and subcutaneous tissue disorders
Ingrown hair	1/20 (5%)	1	0/60 (0%)	0
Rash	1/20 (5%)	1	0/60 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

PIs agree not to present or publish any data or reports collected individually or by subgroup of sites prior to full, initial publication based on all data obtained from all sites.