Assess Aesthetic Improvement and Onset of QM1114-DP in Subjects With Moderate to Severe Glabellar Lines

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-09

Study Completion Date

2023-09-01

Brief Summary

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The objective of this study is to evaluate the aesthetic improvement and onset of QM1114-DP treatment for subjects with moderate to severe glabellar lines

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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

Parallel assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Active arm - QM1114-DP

a Botulinum Toxin Type A (BoNT-A)

Group Type ACTIVE_COMPARATOR

QM1114-DP

Intervention Type BIOLOGICAL

QM1114-DP

Inactive arm - Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo

Interventions

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QM1114-DP

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male or Female 18 years or older
* Moderate to severe GL at maximum frown as assessed by the Investigator
* Moderate to severe GL at maximum frown as assessed by the subject

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes