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

NCT ID: NCT03960957

Last Updated: 2022-08-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

301 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-17

Study Completion Date

2020-04-16

Brief Summary

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

Detailed Description

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Conditions

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Glabellar Frown Lines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental

AbobotulinumtoxinA

Group Type EXPERIMENTAL

AbobotulinumtoxinA

Intervention Type BIOLOGICAL

Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Treatment of glabellar facial lines with placebo

Interventions

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AbobotulinumtoxinA

Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA

Intervention Type BIOLOGICAL

Placebo

Treatment of glabellar facial lines with placebo

Intervention Type OTHER

Eligibility Criteria

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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
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 Study Site

Redondo Beach, California, United States

Site Status

Galderma Study Site

San Diego, California, United States

Site Status

Galderma Study Site

Westport, Connecticut, United States

Site Status

Galderma Study Site

Washington D.C., District of Columbia, United States

Site Status

Galderma Study Site

Coral Gables, Florida, United States

Site Status

Galderma Study Site

Atlanta, Georgia, United States

Site Status

Galderma Study Site

St Louis, Missouri, United States

Site Status

Galderma Study Site

Omaha, Nebraska, United States

Site Status

Galderma Study Site

Cincinnati, Ohio, United States

Site Status

Galderma Study Site

Austin, Texas, United States

Site Status

Galderma Study Site

Spring, Texas, 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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43USD1805

Identifier Type: -

Identifier Source: org_study_id

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