Completed

A Phase 3, Multi-center, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Moderate to Severe Forehead Lines in China

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What is being tested

BOTOX

+ Placebo

Drug
Who is being recruted

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: December 2023
See protocol details

Summary

Principal SponsorAbbVie
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 12, 2023

Actual date on which the first participant was enrolled.

This study aims to determine how safe and effective BOTOX® is for treating moderate to severe forehead lines in Chinese adults. Forehead lines are one of the most noticeable signs of aging, often caused by repeated facial expressions. BOTOX® works by weakening specific muscles with small doses, potentially reducing these lines. This research is significant as it seeks to address the aging concerns in the Chinese population, offering a potential solution to lessen the appearance of deep forehead lines. Participants in the study are divided into two groups. One group receives BOTOX® injections into the muscles on the first day, while the other group might receive a placebo. The study involves around 140 adults and lasts up to 180 days, with regular visits to the study site. During these visits, doctors assess the treatment's effects, monitor any side effects, and participants complete questionnaires. This study might require more effort from participants compared to their usual care, but it helps in understanding how well BOTOX® works for this condition.

Official TitleA Phase 3, Multi-center, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Moderate to Severe Forehead Lines in China
NCT06174688
Principal SponsorAbbVie
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

140 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
Sufficient visual acuity without the use of eyeglasses (contact lens use acceptable) to accurately assess their facial wrinkles.
Participant must have symmetrical FHL of moderate or severe rating at maximum contraction as assessed by both investigator and participant using the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) at Day 1 prior to study treatment.
Participant must have glabellar lines (GL) severity of moderate or severe rating at maximum contraction as assessed by investigator using the FWS-A at Day 1 prior to study treatment.
4 exclusion criteria prevent from participating
Participants with history of known immunization or hypersensitivity to any botulinum toxin serotype.
Participants with history of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.
Presence of tattoos, jewelry, or clothing which obscures or interferes with the target area of interest and cannot be removed.
Participant with history of treatments to the mid- or upper face.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
BOTOX will be injected on Day 1

Group II

Placebo
Placebo will be injected on Day 1

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 12 locations

Suspended

Beijing Hospital /ID# 250059

Beijing, ChinaOpen Beijing Hospital /ID# 250059 in Google Maps
Suspended

Peking University First Hospital /ID# 249912

Xicheng District, China
Suspended

Guangdong Second Provincial General Hospital /ID# 250742

Guangzhou, China
Suspended

The Third Affiliated Hospital, Sun Yat-Sen University /ID# 250148

Guangzhou, China
Completed12 Study Centers