Subject Satisfaction With AbobutulinumtoxinA Treatment

NCT ID: NCT03687736

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

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-02

Study Completion Date

2019-12-04

Brief Summary

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An interventional Phase 4 study to assess subject satisfaction with abobotulinumtoxinA treatment.

Detailed Description

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Following signature of informed consent and the screening process, eligible subjects were treated at the Baseline visit (Day 0) with abobotulinumtoxinA in the glabellar region. Subjects were re-treated at the Month 6 visit.

Conditions

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Glabellar Frown Lines

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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AbobotulinumtoxinA

Open-label

Group Type OTHER

AbobotulinumtoxinA

Intervention Type BIOLOGICAL

AbobotulinumtoxinA treatment in the glabellar region at Baseline and Month 6

Interventions

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AbobotulinumtoxinA

AbobotulinumtoxinA treatment in the glabellar region at Baseline and Month 6

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Moderate to Severe Glabellar Lines at Maximum Frown
* Understands study requirements and signs an informed consent

Exclusion Criteria

* Known allergy to any component of study product
* Pregnant or breast feeding or intending to get pregnant during the study
* Botulinum toxin treatment in the face within 9 months
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

Los Angeles, California, United States

Site Status

Galderma Study Site

San Francisco, California, United States

Site Status

Galderma Study Site

Santa Monica, California, United States

Site Status

Galderma Study Site

Greenwood Village, Colorado, United States

Site Status

Galderma Study Site

Chicago, Illinois, United States

Site Status

Galderma Study Site

Omaha, Nebraska, 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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43USD1802

Identifier Type: -

Identifier Source: org_study_id

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