Trial Outcomes & Findings for A Study to Evaluate Participant Satisfaction and Natural Outcomes Following Administration of BOTOX Cosmetic Injections in Adult Participants for Treatment of Upper Facial Lines (NCT NCT06218251)

Last Updated: 2025-11-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

Day 30

Results posted on

2025-11-24

Participant Flow

Participant milestones

Participant milestones
Measure	BOTOX Participants will receive injections in the glabellar complex, in each of the lateral canthal area, and in the frontalis muscle on Day 1.
Overall Study STARTED	100
Overall Study COMPLETED	96
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	BOTOX Participants will receive injections in the glabellar complex, in each of the lateral canthal area, and in the frontalis muscle on Day 1.
Overall Study Lost to Follow-up	4

Baseline Characteristics

A Study to Evaluate Participant Satisfaction and Natural Outcomes Following Administration of BOTOX Cosmetic Injections in Adult Participants for Treatment of Upper Facial Lines

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BOTOX n=100 Participants Participants will receive injections in the glabellar complex, in each of the lateral canthal area, and in the frontalis muscle on Day 1.
Age, Continuous	45.6 years STANDARD_DEVIATION 12.31 • n=45 Participants
Sex: Female, Male Female	71 Participants n=45 Participants
Sex: Female, Male Male	29 Participants n=45 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=45 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	88 Participants n=45 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=45 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=45 Participants
Race (NIH/OMB) Asian	18 Participants n=45 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=45 Participants
Race (NIH/OMB) Black or African American	11 Participants n=45 Participants
Race (NIH/OMB) White	66 Participants n=45 Participants
Race (NIH/OMB) More than one race	5 Participants n=45 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=45 Participants

PRIMARY outcome

Timeframe: Day 30

Population: Modified Intent-to-Treat Population N is Number of subjects with observed measurements at the visit.

Outcome measures

Outcome measures
Measure	BOTOX n=95 Participants Participants will receive injections in the glabellar complex, in each of the lateral canthal area, and in the frontalis muscle on Day 1.
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

SECONDARY outcome

Timeframe: Day 30

Population: Modified Intent-to-Treat Population N is Number of participants with observed measurements at both baseline and the given visit.

The FACE-Q Psychological Function is a 10-item scale that measures psychological function. The responses score ranges from 0 to 100. Higher scores reflect a better outcome.

Outcome measures

Outcome measures
Measure	BOTOX n=83 Participants Participants will receive injections in the glabellar complex, in each of the lateral canthal area, and in the frontalis muscle on Day 1.
Change From Baseline in Overall Score of the Participant's Assessment of FACE-Q Psychological Function	20.1 units on a scale Standard Deviation 17.96

Adverse Events

BOTOX

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BOTOX n=100 participants at risk Participants will receive injections in the glabellar complex, in each of the lateral canthal area, and in the frontalis muscle on Day 1.
Ear and labyrinth disorders EAR PAIN	1.0% 1/100 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 182 days for BOTOX.
Eye disorders CONJUNCTIVAL HAEMORRHAGE	1.0% 1/100 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 182 days for BOTOX.
General disorders FACIAL DISCOMFORT	2.0% 2/100 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 182 days for BOTOX.
Infections and infestations BRONCHITIS	1.0% 1/100 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 182 days for BOTOX.
Infections and infestations CELLULITIS	1.0% 1/100 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 182 days for BOTOX.
Infections and infestations COVID-19	2.0% 2/100 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 182 days for BOTOX.
Infections and infestations NASOPHARYNGITIS	1.0% 1/100 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 182 days for BOTOX.
Infections and infestations URINARY TRACT INFECTION	1.0% 1/100 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 182 days for BOTOX.
Injury, poisoning and procedural complications CONTUSION	1.0% 1/100 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 182 days for BOTOX.
Injury, poisoning and procedural complications FALL	1.0% 1/100 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 182 days for BOTOX.
Injury, poisoning and procedural complications LIGAMENT SPRAIN	1.0% 1/100 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 182 days for BOTOX.
Musculoskeletal and connective tissue disorders BACK PAIN	2.0% 2/100 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 182 days for BOTOX.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) DYSPLASTIC NAEVUS	1.0% 1/100 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 182 days for BOTOX.
Nervous system disorders HEADACHE	6.0% 6/100 • Number of events 9 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 182 days for BOTOX.
Skin and subcutaneous tissue disorders BROW PTOSIS	1.0% 1/100 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 182 days for BOTOX.

Additional Information

AbbVie

ABBVIE CALL CENTER

Phone: 844-663-3742

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place