DWP450 for Treating Moderate to Severe Glabellar Lines

NCT ID: NCT06354127

Last Updated: 2024-04-09

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

473 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-12

Study Completion Date

2021-01-25

Brief Summary

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A multi-center, randomized, double-blind, positive drug-controlled clinical study to evaluate the safety and efficacy of Botulinum Toxin Type A for Injection in the treatment of moderate to severe glabellar lines

Detailed Description

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Conditions

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Moderate to Severe Glabellar 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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DWP450

Group Type EXPERIMENTAL

DWP450

Intervention Type DRUG

The test drug or control drug is injected on the day of administration.

Botox®

Group Type ACTIVE_COMPARATOR

Botox®

Intervention Type DRUG

The test drug or control drug is injected on the day of administration.

Interventions

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DWP450

The test drug or control drug is injected on the day of administration.

Intervention Type DRUG

Botox®

The test drug or control drug is injected on the day of administration.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult males or females aged 20-65 years old.
* Moderate to severe (grade 2-3) glabellar lines based on investigator's assessment of severity of glabellar lines at maximum frown.

Exclusion Criteria

* Having received any glabellar (including forehead) cosmetic procedures/surgeries, such as dermal filling, face lifting, photoelectric therapy, hydro lifting, microneedle, chemical peeling or scar removal surgery, or dermabrasion within 6 months prior to screening.
* Planning to receive any facial cosmetic procedures/surgeries, including but not limited dermal filling, face lifting, photoelectric therapy, hydro lifting, microneedle, chemical peeling or scar removal surgery, during the study period.
* Skin infection at injection site or systemic skin disease assessed with the potential to interfere with efficacy evaluation or safety evaluation of glabellar lines or forehead lines.
* Glabellar lines that cannot be fully flattened through surgery, by hand or by other methods.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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DW_DWP450009

Identifier Type: -

Identifier Source: org_study_id

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