Trial Outcomes & Findings for Combination Facial Aesthetic Treatment in Millennials (NCT NCT04755595)

Results Overview

To assess changes in patient's satisfaction with their appearance following a combination facial aesthetic treatment, using the FACE-Q Satisfaction with Facial Appearance Overall Scale. This tool consists of several questions. For each question, the study participant selects a number from 1 to 4. Higher number are associated with higher satisfaction with facial appearance. The raw scores of the primary outcome measure were transformed by the Rasch measurement method into a 0-to-100 point scale.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Baseline and 2 months after the procedure

Results posted on

2025-01-14

Participant Flow

Participant milestones

Participant milestones
Measure	Facial Aesthetic Treatment Study participants will receive all three injectables: Botox Cosmetic (onabotulinumtoxinA), Juvéderm Voluma XC (hyaluronic acid gel filler), and Juvéderm Volbella XC (hyaluronic acid gel filler) during a single procedure, with an optional touch-up treatment at 2 weeks. Botox Cosmetic Injectable Product: Acetylcholine release inhibitor and a neuromuscular blocking agent Juvéderm Voluma XC: Gel implants consisting of cross-linked hyaluronic acid Juvéderm Volbella XC: Gel implants consisting of cross-linked hyaluronic acid
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Facial Aesthetic Treatment Study participants will receive all three injectables: Botox Cosmetic (onabotulinumtoxinA), Juvéderm Voluma XC (hyaluronic acid gel filler), and Juvéderm Volbella XC (hyaluronic acid gel filler) during a single procedure, with an optional touch-up treatment at 2 weeks. Botox Cosmetic Injectable Product: Acetylcholine release inhibitor and a neuromuscular blocking agent Juvéderm Voluma XC: Gel implants consisting of cross-linked hyaluronic acid Juvéderm Volbella XC: Gel implants consisting of cross-linked hyaluronic acid
Overall Study Lost to Follow-up	1

Baseline Characteristics

Combination Facial Aesthetic Treatment in Millennials

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Facial Aesthetic Treatment n=20 Participants Study participants will receive all three injectables: Botox Cosmetic (onabotulinumtoxinA), Juvéderm Voluma XC (hyaluronic acid gel filler), and Juvéderm Volbella XC (hyaluronic acid gel filler) during a single procedure, with an optional touch-up treatment at 2 weeks. Botox Cosmetic Injectable Product: Acetylcholine release inhibitor and a neuromuscular blocking agent Juvéderm Voluma XC: Gel implants consisting of cross-linked hyaluronic acid Juvéderm Volbella XC: Gel implants consisting of cross-linked hyaluronic acid
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	29.8 years STANDARD_DEVIATION 4.2 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized White, Non-Hispanic	13 Participants n=5 Participants
Race/Ethnicity, Customized White, Hispanic	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants
Race/Ethnicity, Customized Two or more races	2 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 2 months after the procedure

To assess changes in patient's satisfaction with their appearance following a combination facial aesthetic treatment, using the FACE-Q Satisfaction with Facial Appearance Overall Scale. This tool consists of several questions. For each question, the study participant selects a number from 1 to 4. Higher number are associated with higher satisfaction with facial appearance. The raw scores of the primary outcome measure were transformed by the Rasch measurement method into a 0-to-100 point scale.

Outcome measures

Outcome measures
Measure	Baseline n=20 Participants Baseline assessment of satisfaction of overall facial appearance.	Post-treatment n=19 Participants Post-treatment assessment of satisfaction of overall facial appearance (conducted 2 months post-combination facial aesthetic treatment using soft tissue fillers and botulinum toxin).
FACE-Q Satisfaction With Facial Appearance Overall Scale	42.35 score on a scale Standard Deviation 8.94	59.42 score on a scale Standard Deviation 15.08

SECONDARY outcome

Timeframe: Baseline and 2 months after the procedure

To assess changes in patient dissatisfaction with the appearance of overall facial lines, using the FACE-Q Appraisal of Lines: Overall Scale. The tool consists of ten questions regarding self-perception of overall facial lines. For each question, study participants select a number from 1 to 4, with higher numbers reflecting greater dissatisfaction with facial lines. The total score is tallied. The minimum total score is 10 and the maximum total score is 40. A higher total score is associated with greater dissatisfaction with facial lines. The mean total score at baseline and 2 months post procedure are reported.

Outcome measures

Outcome measures
Measure	Baseline n=20 Participants Baseline assessment of satisfaction of overall facial appearance.	Post-treatment n=19 Participants Post-treatment assessment of satisfaction of overall facial appearance (conducted 2 months post-combination facial aesthetic treatment using soft tissue fillers and botulinum toxin).
FACE-Q Appraisal of Lines Overall	21.5 score on a scale Standard Deviation 6.8	15.1 score on a scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: At baseline

To assess patient expectations regarding the impact of facial aesthetic treatment on their lives, using the FACE-Q Expectations Scale. This tool consists of eight statements. For each statement, the study participant selects a number from 1 to 4, where 1 represents "definitely disagree", 2 represents "somewhat disagree", 3 represents "somewhat agree", and 4 represents "definitely agree". The total score of the statements is tallied. The minimum total score is 8 and the maximum total score is 32. The higher the total score, the greater positive impact the participants believe the treatments will have on their lives. The mean total score at baseline is reported.

Outcome measures

Outcome measures
Measure	Baseline n=20 Participants Baseline assessment of satisfaction of overall facial appearance.	Post-treatment Post-treatment assessment of satisfaction of overall facial appearance (conducted 2 months post-combination facial aesthetic treatment using soft tissue fillers and botulinum toxin).
FACE-Q Expectations Scale	17.4 score on a scale Standard Deviation 4.6	—

SECONDARY outcome

Timeframe: Baseline and 2 months after the procedure

To assess changes in psychosocial factors after facial aesthetic treatment, using FACE-Q Social Function Scale. This tool consists of eight statements. For each statement, the study participant selects a number from 1 to 4, where 1 represents "definitely disagree", 2 represents "somewhat disagree", 3 represents "somewhat agree", and 4 represents "definitely agree". The total score of the statements is tallied for each patient. The minimum total score is 8 and the maximum total score is 32. A higher total score reflects greater social functioning. The mean total score is reported at baseline and 2 months after the procedure.

Outcome measures

Outcome measures
Measure	Baseline n=20 Participants Baseline assessment of satisfaction of overall facial appearance.	Post-treatment n=19 Participants Post-treatment assessment of satisfaction of overall facial appearance (conducted 2 months post-combination facial aesthetic treatment using soft tissue fillers and botulinum toxin).
FACE-Q Social Function Scale	24.4 score on a scale Standard Deviation 4.6	27.4 score on a scale Standard Deviation 4.3

SECONDARY outcome

Timeframe: Baseline and 2 months after the procedure

To assess changes in self-perceived age after facial aesthetic treatment, using the FACE-Q Patient-Perceived Age Visual Analogue Scale. The study participant selects a number on the scale from -15 to +15. 0 corresponds to "I look my age". -15 corresponds to "I look 15 years younger". +15 corresponds to "I look 15 years older". The mean score at baseline and 2 months post procedure are reported.

Outcome measures

Outcome measures
Measure	Baseline n=20 Participants Baseline assessment of satisfaction of overall facial appearance.	Post-treatment n=19 Participants Post-treatment assessment of satisfaction of overall facial appearance (conducted 2 months post-combination facial aesthetic treatment using soft tissue fillers and botulinum toxin).
FACE-Q Patient-Perceived Age Visual Analogue Scale	0.2 score on a scale Standard Deviation 2.3	-2.2 score on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: Baseline and 2 months after the procedure

To assess changes in patient satisfaction with the appearance of their cheeks after facial aesthetic treatment, using the FACE-Q Satisfaction with Cheeks Scale. The tool consists of five questions regarding self-perception of cheeks. For each question, study participants select a number from 1 to 4, with higher numbers reflecting greater satisfaction with cheeks. The total score is tallied. The minimum total score is 5 and the maximum total score is 20. A higher total score is associated with greater satisfaction with cheeks. The mean total score at baseline and 2 months post procedure are reported.

Outcome measures

Outcome measures
Measure	Baseline n=20 Participants Baseline assessment of satisfaction of overall facial appearance.	Post-treatment n=19 Participants Post-treatment assessment of satisfaction of overall facial appearance (conducted 2 months post-combination facial aesthetic treatment using soft tissue fillers and botulinum toxin).
FACE-Q Satisfaction With Cheeks	13.3 score on a scale Standard Deviation 3.4	16.9 score on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: 2 months after the procedure

To assess patient satisfaction with facial aesthetic treatment, using the FACE-Q Satisfaction with Outcome Scale. This tool consists of six statements. For each statement, the study participant selects a number from 1 to 4, where 1 represents "definitely disagree", 2 represents "somewhat disagree", 3 represents "somewhat agree", and 4 represents "definitely agree". The total score is tallied. The minimum total score is 6 and the maximum total score is 24. A higher total score is associated with greater satisfaction with outcome. The mean total score 2 months after the procedure is reported.

Outcome measures

Outcome measures
Measure	Baseline n=19 Participants Baseline assessment of satisfaction of overall facial appearance.	Post-treatment Post-treatment assessment of satisfaction of overall facial appearance (conducted 2 months post-combination facial aesthetic treatment using soft tissue fillers and botulinum toxin).
FACE-Q Satisfaction With Outcome Scale	20.8 score on a scale Standard Deviation 2.9	—

SECONDARY outcome

Timeframe: Baseline and 2 months after the procedure

To assess changes in psychosocial factors after facial aesthetic treatment, using the FACE-Q Psychological Function Scale. This tool consists of ten statements. For each statement, the study participant selects a number from 1 to 4, where 1 represents "definitely disagree", 2 represents "somewhat disagree", 3 represents "somewhat agree", and 4 represents "definitely agree". The total score is tallied. The minimum total score is 10 and the maximum total score is 40. A higher total score is associated with better psychological functioning. The mean total score at baseline and 2 months after the procedure are reported.

Outcome measures

Outcome measures
Measure	Baseline n=20 Participants Baseline assessment of satisfaction of overall facial appearance.	Post-treatment n=19 Participants Post-treatment assessment of satisfaction of overall facial appearance (conducted 2 months post-combination facial aesthetic treatment using soft tissue fillers and botulinum toxin).
FACE-Q Psychological Function Scale	30.5 score on a scale Standard Deviation 8.2	34.9 score on a scale Standard Deviation 5.1

SECONDARY outcome

Timeframe: 2 months after the procedure compared to baseline

To assess changes in self-perceived age after facial aesthetic treatment, using the FACE-Q Aging Appraisal Scale. This tool consists of seven statements. For each statement, the study participant selects a number from 1 to 4, where 1 represents "definitely disagree", 2 represents "somewhat disagree", 3 represents "somewhat agree", and 4 represents "definitely agree". The total score is tallied. The minimum total score is 7 and the maximum total score is 28. A lower total score is associated with greater satisfaction with self-perceived age. The mean total score at baseline and 2 months after the procedure are reported.

Outcome measures

Outcome measures
Measure	Baseline n=20 Participants Baseline assessment of satisfaction of overall facial appearance.	Post-treatment n=19 Participants Post-treatment assessment of satisfaction of overall facial appearance (conducted 2 months post-combination facial aesthetic treatment using soft tissue fillers and botulinum toxin).
FACE-Q Aging Appraisal Scale	12.6 score on a scale Standard Deviation 5.6	9.8 score on a scale Standard Deviation 4.8

SECONDARY outcome

Timeframe: Baseline and 2 months after the procedure

To assess changes in patient satisfaction with the appearance of their lips after facial aesthetic treatment, using the FACE-Q Satisfaction with Lips Scale. The tool consists of ten questions regarding self-perception of lips. For each question, study participants select a number from 1 to 4, with higher numbers reflecting greater satisfaction with lips. The total score is tallied. The minimum total score is 10 and the maximum total score is 40. A higher total score is associated with greater satisfaction with lips. The mean total score at baseline and 2 months post procedure are reported.

Outcome measures

Outcome measures
Measure	Baseline n=20 Participants Baseline assessment of satisfaction of overall facial appearance.	Post-treatment n=19 Participants Post-treatment assessment of satisfaction of overall facial appearance (conducted 2 months post-combination facial aesthetic treatment using soft tissue fillers and botulinum toxin).
FACE-Q Satisfaction With Lips	25.4 score on a scale Standard Deviation 7.3	34.9 score on a scale Standard Deviation 4.4

Adverse Events

Facial Aesthetic Treatment

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Facial Aesthetic Treatment n=20 participants at risk Study participants will receive all three injectables: Botox Cosmetic (onabotulinumtoxinA), Juvéderm Voluma XC (hyaluronic acid gel filler), and Juvéderm Volbella XC (hyaluronic acid gel filler) during a single procedure, with an optional touch-up treatment at 2 weeks. Botox Cosmetic Injectable Product: Acetylcholine release inhibitor and a neuromuscular blocking agent Juvéderm Voluma XC: Gel implants consisting of cross-linked hyaluronic acid Juvéderm Volbella XC: Gel implants consisting of cross-linked hyaluronic acid
Skin and subcutaneous tissue disorders Bruising	45.0% 9/20 • Adverse events were collected over two months.
Skin and subcutaneous tissue disorders Edema	70.0% 14/20 • Adverse events were collected over two months.
General disorders Headache	20.0% 4/20 • Adverse events were collected over two months.
General disorders Soreness	20.0% 4/20 • Adverse events were collected over two months.
Skin and subcutaneous tissue disorders Lumps localized to midface dermal filler injection sites	5.0% 1/20 • Adverse events were collected over two months.

Additional Information

Jared Jagdeo MD, MS

SUNY Downstate Health Sciences University

Phone: (718) 270-1229

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place