A Study to Evaluate Participant Satisfaction and Natural Outcomes Following Administration of BOTOX Cosmetic Injections in Adult Participants for Treatment of Upper Facial Lines
- Registration Number
- NCT06218251
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BOTOX BOTOX Participants will receive injections in the glabellar complex, in each of the lateral canthal area, and in the frontalis muscle on Day 1.
- Primary Outcome Measures
Name Time Method 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) Day 30 The FLSQ consists of 13 questions that assess treatment satisfaction and psychosocial impact. Participants assessed their satisfaction with upper facial lines using the FLSQ 5-point scale where: -2=Very dissatisfied and 2=Very satisfied.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Overall Score of the Participant's Assessment of FACE-Q Psychological Function Day 30 The FACE-Q Psychological Function is a 10-item scale that measures psychological function with a 4-point response options ranging from "definitely disagree" to "definitely agree". The responses will be summed and converted to a Rasch transformed score that ranges from 0 to 100. Higher scores indicate higher satisfaction.
Trial Locations
- Locations (10)
Skin Wellness Dermatology - Homewood /ID# 248469
🇺🇸Birmingham, Alabama, United States
The Research Center at The Maas Clinic /ID# 256633
🇺🇸San Francisco, California, United States
Pacific Clinical Innovations /ID# 248467
🇺🇸Vista, California, United States
Kavali Plastic Surgery and Skin Renewal Center /ID# 248472
🇺🇸Atlanta, Georgia, United States
Tennessee Clinical Research Center /ID# 259161
🇺🇸Nashville, Tennessee, United States
Integrated Aesthetics - Spring /ID# 257738
🇺🇸Spring, Texas, United States
SkinDC /ID# 248470
🇺🇸Arlington, Virginia, United States
Skin Matters Medical Aesthetic Centre /ID# 249539
🇨🇦Vancouver, British Columbia, Canada
Project Skin MD - Ottawa /ID# 249718
🇨🇦Ottawa, Ontario, Canada
Bertucci MedSpa Inc. /ID# 249757
🇨🇦Woodbridge, Ontario, Canada