Clinical trial NCT06218251: A Study to Evaluate Participant Satisfaction and Natural Outcomes Following Administration of BOTOX Cosmetic Injections in Adult Participants for Treatment of Upper Facial Lines
Official title: A Prospective, Multi-center, Open-label Study to Evaluate Subject Satisfaction and Natural Outcomes Following Administration of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Subjects With Upper Facial Lines (Glabellar Lines, Lateral Canthal Lines, and Forehead Lines)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Upper Facial Lines
Keywords: Glabellar Lines
Lateral Canthal Lines
Forehead Lines
BOTOX
Botulinum Toxin Type A
OnabotulinumtoxinA
Upper Facial Lines
Crows Feet Lines
Wrinkles
Facial Wrinkles
Facial Rhytides
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-01-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Facial lines that develop from repeated facial expression, such as glabellar lines (GL), lateral canthal lines (LCL), and forehead lines (FHL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to evaluate participant satisfaction and natural outcomes following the administration of BOTOX Cosmetic in adult participants with upper facial lines (GL, LCL, and FHL).

This is an open-label study in which all participants will receive active study treatment. Around 100 adult participants with an assessment of moderate to severe GL, LCL, and FHL, will be enrolled at approximately 10 sites in the United States and Canada.

Participants will receive BOTOX Cosmetic as intramuscular injections to the glabellar lines, lateral canthal lines, and forehead lines at Day 1.

Participants will attend regular visits during the study. The effect of the treatment will be checked by medical assessments for side effects and questionnaires will be completed during regular study visits.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe Glabellar Lines, Lateral Canthal Lines, and Forehead Lines.
* Sufficient visual acuity without the use of eyeglasses (contact lens use acceptable) to accurately assess their facial wrinkles.

Exclusion Criteria:

* Presence or history of any medical condition that may place the participant at increased risk to BOTOX Cosmetic or interfere with the study evaluation.
* Presence of tattoos, jewelry, or clothing which obscures or interferes with the target area of interest and cannot be removed.
* History of known immunization or hypersensitivity to any botulinum toxin serotype.

Primary outcomes:
measure: Percentage of Participants with Responder Status of 'Mostly satisfied' or 'Very satisfied' on the Facial Line Satisfaction Questionnaire (FLSQ) Follow Up Item 4 (Satisfaction with the Natural Look)
timeFrame: Day 30
Secondary outcomes:
measure: Change From Baseline in Overall Score of the Participant's Assessment of FACE-Q Psychological Function
timeFrame: Day 30
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Skin Wellness Dermatology - Homewood /ID# 248469
state: Alabama
city: San Francisco
country: United States
facility: The Research Center at The Maas Clinic /ID# 256633
state: California
city: Vista
country: United States
facility: Pacific Clinical Innovations /ID# 248467
state: California
city: Atlanta
country: United States
facility: Kavali Plastic Surgery and Skin Renewal Center /ID# 248472
state: Georgia
city: Nashville
country: United States
facility: Tennessee Clinical Research Center /ID# 259161
state: Tennessee
city: Spring
country: United States
facility: Integrated Aesthetics - Spring /ID# 257738
state: Texas
city: Arlington
country: United States
facility: SkinDC /ID# 248470
state: Virginia
city: Vancouver
country: Canada
facility: Skin Matters Medical Aesthetic Centre /ID# 249539
state: British Columbia
city: Ottawa
country: Canada
facility: Project Skin MD - Ottawa /ID# 249718
state: Ontario
city: Woodbridge
country: Canada
facility: Bertucci MedSpa Inc. /ID# 249757
state: Ontario
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: