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Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Platysmal Bands

NCT ID: NCT04080882

Last Updated: 2022-08-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-25

Study Completion Date

2020-06-04

Brief Summary

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

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Detailed Description

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Conditions

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Platysmal Bands

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AbobotulinumtoxinA dose 1

AbobotulinumtoxinA dose 1 injected into platysma bands

Group Type ACTIVE_COMPARATOR

AbobotulinumtoxinA dose 1

Intervention Type BIOLOGICAL

Treatment of platysmal bands

placebo

placebo injected into platysma bands

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Treatment of platysmal bands

AbobotulinumtoxinA dose 2

AbobotulinumtoxinA dose 2 injected into platysma bands

Group Type ACTIVE_COMPARATOR

AbobotulinumtoxinA dose 2

Intervention Type BIOLOGICAL

Treatment of platysmal bands

AbobotulinumtoxinA dose 3

AbobotulinumtoxinA dose 3 injected into platysma bands

Group Type ACTIVE_COMPARATOR

AbobotulinumtoxinA dose 3

Intervention Type BIOLOGICAL

Treatment of platysmal bands

Interventions

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AbobotulinumtoxinA dose 1

Treatment of platysmal bands

Intervention Type BIOLOGICAL

Placebo

Treatment of platysmal bands

Intervention Type OTHER

AbobotulinumtoxinA dose 2

Treatment of platysmal bands

Intervention Type BIOLOGICAL

AbobotulinumtoxinA dose 3

Treatment of platysmal bands

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Galderma Research Site

Encinitas, California, United States

Site Status

Galderma Research Site

Encino, California, United States

Site Status

Galderma Research Site

Boynton Beach, Florida, United States

Site Status

Galderma Research Site

Miami, Florida, United States

Site Status

Galderma Research Site

New Orleans, Louisiana, United States

Site Status

Galderma Research Site

New Orleans, Louisiana, United States

Site Status

Galderma Research Site

Baltimore, Maryland, United States

Site Status

Galderma Research Site

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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43USD1804

Identifier Type: -

Identifier Source: org_study_id

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