A Study to Assess the Adverse Events and Effectiveness of BOTOX Injections for the Treatment of M… (NCT06174688) | Clinical Trial Compass
CompletedPhase 3
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
China140 participantsStarted 2023-12-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants who Achieved 'None' or 'Mild' on Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) According to the Investigator Assessment of Forehead Lines (FHL) Severity
Timeframe: Day 30
2
Percentage of Participants who Achieved 'None' or 'Mild' on FWS-A According to the Participant Assessment of FHL Severity