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A Study to Assess the Adverse Events and Effectiveness of BOTOX Injections for the Treatment of Moderate to Severe Forehead Lines in Chinese Adult Participants

NCT06174688 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-08-28

No results posted yet for this study

Summary

Facial lines (such as glabellar lines \[GL\], lateral canthal lines \[LCL\], and forehead lines \[FHL\]) are perhaps the most visible signs of aging. Hyperfunctional facial lines that develop from repeated facial expression may be treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to assess adverse events and effectiveness of BOTOX in Chinese adults with moderate to severe FHL.

Participants are placed in 1 of 2 groups, called treatment arms. Around 140 adult participants with moderate to severe FHL will be enrolled in the study.

Participants in the treatment group will receive intramuscular injections on Day 1 and followed for up to 180 Days.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at the study site. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Conditions

  • Forehead Lines

Interventions

DRUG

BOTOX

Intramuscular Injections

DRUG

Placebo

Intramuscular Injections

Sponsors & Collaborators

Principal Investigators

  • ABBVIE INC. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-12
Primary Completion
2024-09-13
Completion
2024-09-13

Countries

  • China

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06174688 on ClinicalTrials.gov