NCT04609020

Study to Evaluate Subject Satisfaction With Facial Appearance and Impact of Combined Facial Treatment

Completed Phase 4 Results posted Last updated 17 June 2025

What this trial tests

Phase 4 trial testing JUVÉDERM in Facial Rhytides in 64 participants. Completed in 10 May 2024.

Timeline

15 February 2023

Primary endpoint
10 May 2024

10 May 2024

Quick facts

Lead sponsor	Allergan
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	64
Start date	15 February 2023
Primary completion	10 May 2024
Estimated completion	10 May 2024
Sites	6 locations across Brazil

Drugs / interventions tested

• JUVÉDERM — full drug profile →
• BOTOX (ONABOTULINUMTOXINA) — full drug profile →
• HArmonyCA Lidocaine

Conditions studied

• Facial Rhytides — all drugs for Facial Rhytides →
• Skin Folds — all drugs for Skin Folds →
• Loss of Volume and Skin Quality — all drugs for Loss of Volume and Skin Quality →

Sponsor

Allergan — full company profile →

Who can join

Adults 35 to 65, any sex, with Facial Rhytides or Skin Folds. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in the Rasch-transformed Score of the FACE-Q Satisfaction With Facial Appearance Scale. Primary · Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)

The FACE-Q questionnaire focuses on patient's satisfaction with facial appearance at the final study visit compared to before starting study treatment and is a 10- item questionnaire. Overall scores range from 0 to 100 with higher scores representing higher satisfaction.

Group	Value	95% CI
HArmonyCA	46.6	± 23.61

Change From Baseline in the FACE-Q Aging Appraisal Secondary · Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)

The FACE-Q questionnaire is a 7-item questionnaire with overall scores that range from 0 to 100 and higher scores reflecting a better outcome.

Group	Value	95% CI
HArmonyCA	35.3	± 22.36

Change From Baseline in the Rasch-transformed Score of the FACE-Q Psychological Function Scale Secondary · Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)

The FACE-Q questionnaire is a 10-item questionnaire with overall scores that range from 0 to 100 and higher scores reflecting a better outcome.

Group	Value	95% CI
HArmonyCA	27.6	± 23.23

Change From Baseline in the Rasch-transformed Score of the FACE-Q Social Function Scale Secondary · Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)

The FACE-Q questionnaire is a 8-item questionnaire with overall scores that range from 0 to 100 and higher scores reflecting a better outcome.

Group	Value	95% CI
HArmonyCA	22.9	± 20.56

Change From Baseline in the Rasch-transformed Score of the FACE-Q Satisfaction With Skin Secondary · Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)

The FACE-Q questionnaire is a 12- item questionnaire. Overall scores range from 0 to 100 with higher scores representing higher satisfaction.

Group	Value	95% CI
HArmonyCA	43.1	± 22.25

Change From Baseline Self-Perception of Age Secondary · Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)

Subject's assessment of self-perception of age as measured by SPA. Subject's selected one of 3 options based on how they felt their facial appearance looked compared to their age on the day they completed the assessment, writing in the number of years when appropriate.

I look ___ years younger

Group	Value	95% CI
HArmonyCA	3.0	0 – 13

I look ___ years older

Group	Value	95% CI
HArmonyCA	0	0 – 0

Investigator's Assessment Using Global Aesthetic Improvement Scale (GAIS) Secondary · Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)

Five point ordinal scale measuring the change in facial aesthetic improvement from -2 (Much Worse) to 2 (Much Improved) assessed by the Investigator.

Group	Value	95% CI
HArmonyCA	47
HArmonyCA	15
HArmonyCA	0
HArmonyCA	0

Subject's Assessment Using Global Aesthetic Improvement Scale (GAIS) Secondary · Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)

Five point ordinal scale measuring the change in facial aesthetic improvement from -2 (Much Worse) to 2 (Much Improved) assessed by the subject.

Group	Value	95% CI
HArmonyCA	51
HArmonyCA	11
HArmonyCA	0
HArmonyCA	0

Change From Baseline to End of Study of Periorbital Aesthetic Appearance Questionnaire (PAAQ) Secondary · Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)

Questionnaire evaluating the subject's overall eye appearance from 0 (Never) to 4 (All of the Time) for each of the 9 items. All items were transformed to a scale from 0 (no negative impact) to 100 (high negative impact). Total transformed score is based on 9 individual items each item has a range of 0 to 4, the transformed score ranges from 0 to 100. Psychological domain is based on the average of the sum of transformed scores of individual items 2, 4, 6, 7, and 8. Score will also range from 0 to 100 with same interpretation as the total transformed score. Appearance domain is based on the

Change from Baseline Transformed Total Score

Group	Value	95% CI
HArmonyCA	-40.3	-86 – 39

Change from Baseline Psychological Domain

Group	Value	95% CI
HArmonyCA	-40.0	-90 – 45

Change from Baseline Appearance Domain

Group	Value	95% CI
HArmonyCA	-45.8	-100 – 42

Change from Baseline Coping Domain

Group	Value	95% CI
HArmonyCA	-50.0	-100 – 25

Adverse events — posted to ClinicalTrials.gov

Time frame: 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 147 days for HArmonyCA.. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

HArmonyCA

Serious: 2/64 (3%)

Deaths: 0/64

Serious adverse events (2 terms)

Reaction	System	HArmonyCA
PYELONEPHRITIS	Infections and infestations	—
RHABDOMYOLYSIS	Musculoskeletal and connective tissue disorders	—

Other adverse events (13 terms — click to expand)

Reaction	System	HArmonyCA
INJECTION SITE OEDEMA	General disorders	—
PERIORBITAL OEDEMA	Eye disorders	—
DIARRHOEA	Gastrointestinal disorders	—
LIP OEDEMA	Gastrointestinal disorders	—
VOMITING	Gastrointestinal disorders	—
INJECTION SITE BRUISING	General disorders	—
INJECTION SITE INDURATION	General disorders	—
INJECTION SITE NODULE	General disorders	—
OEDEMA PERIPHERAL	General disorders	—
DENGUE FEVER	Infections and infestations	—
GASTROENTERITIS VIRAL	Infections and infestations	—
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	—
HYPOGLYCAEMIA	Metabolism and nutrition disorders	—

Most-reported serious reactions: PYELONEPHRITIS, RHABDOMYOLYSIS.

Data from ClinicalTrials.gov NCT04609020 adverse events section.

Sponsor's own description

The primary objective of this study is to quantify the psychological, social, and emotional impact of comprehensive aesthetic treatment with a portfolio of the Sponsor's products by measuring the change in subject's satisfaction with facial appearance from baseline (before any treatment) to the final study visit

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.