Assess Aesthetic Improvement With QM1114-DP in Subjects With Moderate to Severe Lateral Canthal Lines and Glabellar Lines

NCT ID: NCT05148000

Last Updated: 2024-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-23

Study Completion Date

2023-06-23

Brief Summary

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This study to assess aesthetic improvement following treatment with QM1114-DP.

Detailed Description

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This is an open-label, single-center multi-center study to assess aesthetic improvement in the Glabellar and Lateral Canthal regions following treatment with QM1114-DP.

Conditions

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Glabellar Frown Lines Canthal Lines

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open Label single site study for treatment of GL and LCL with single treatment of QM1114-DP
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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QM1114-DP

QM1114-DP

Group Type EXPERIMENTAL

QM1114-DP

Intervention Type BIOLOGICAL

QM1114-DP

Interventions

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QM1114-DP

QM1114-DP

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male or Female 18 years or older
* Moderate to severe bilaterally symmetrical LCL as assessed by the investigator
* Moderate to severe GL at maximum frown as assessed by the Investigator

Exclusion Criteria

* Previous use of any botulinum toxin in facial areas within 9 months prior to study treatment
* Female who is pregnant, breast feeding or intends to conceive a child during the study.
* Known allergy to hypersensitivity or any component of the Investigational product
Minimum Eligible Age

18 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

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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43QM2107

Identifier Type: -

Identifier Source: org_study_id

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