Phase 4
N=100
A Study to Evaluate Participant Satisfaction and Natural Outcomes Following Administration of BOTOX Cosmetic Injections in Adult Participants for Treatment of Upper Facial Lines
Upper Facial Lines
Bottom Line
View on ClinicalTrials.gov: NCT06218251 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: 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) — 86 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- BOTOX (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
86 | — |
| SECONDARY Change From Baseline in Overall Score of the Participant's Assessment of FACE-Q Psychological Function |
20.1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT06218251). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.