Status:
COMPLETED
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
Lead Sponsor:
AbbVie
Conditions:
Forehead Lines
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 rep...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2024
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06174688
Start Date
December 12 2023
End Date
September 13 2024
Last Update
August 28 2025
Active Locations (12)
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1
Beijing Hospital /ID# 250059
Beijing, Beijing Municipality, China, 100730
2
Peking University First Hospital /ID# 249912
Xicheng District, Beijing Municipality, China, 100034
3
Guangdong Second Provincial General Hospital /ID# 250742
Guangzhou, Guangdong, China, 510310
4
The Third Affiliated Hospital, Sun Yat-Sen University /ID# 250148
Guangzhou, Guangdong, China, 510630