Trial Outcomes & Findings for Study to Evaluate Subject Satisfaction With Facial Appearance and Impact of Combined Facial Treatment (NCT NCT04609020)
NCT ID: NCT04609020
Last Updated: 2025-06-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
64 participants
Primary outcome timeframe
Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)
Results posted on
2025-06-17
Participant Flow
Participant milestones
| Measure |
HArmonyCA
All treatments will be administered according to the respective label and according to an agreed upon treatment plan between the subject and Health Care Provider. If required: HarmonyCA Lidocaine will be administered at Visit 1, Juvéderm filler injections (JUVÉDERM VOLBELLA with Lidocaine, and/or JUVÉDERM VOLIFT with Lidocaine, and/or JUVÉDERM VOLUMA with Lidocaine, and/or JUVÉDERM VOLITE with Lidocaine and/or JUVÉDERM VOLUX with Lidocaine) will be administered at Visit 3, BOTOX will be administered at Visit 5. Touch-ups may be performed as required by subject's treatment plan after each study visit.
Device: HArmonyCa Lidocaine injectable gel is a dermal filler intended for facial soft tissue augmentation.
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Overall Study
STARTED
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64
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Overall Study
COMPLETED
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64
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
HArmonyCA
n=64 Participants
All treatments will be administered according to the respective label and according to an agreed upon treatment plan between the subject and Health Care Provider. If required: HarmonyCA Lidocaine will be administered at Visit 1, Juvéderm filler injections (JUVÉDERM VOLBELLA with Lidocaine, and/or JUVÉDERM VOLIFT with Lidocaine, and/or JUVÉDERM VOLUMA with Lidocaine, and/or JUVÉDERM VOLITE with Lidocaine and/or JUVÉDERM VOLUX with Lidocaine) will be administered at Visit 3, BOTOX will be administered at Visit 5. Touch-ups may be performed as required by subject's treatment plan after each study visit.
Device: HArmonyCa Lidocaine injectable gel is a dermal filler intended for facial soft tissue augmentation.
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Age, Continuous
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48.4 years
STANDARD_DEVIATION 7.37 • n=64 Participants
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Sex: Female, Male
Female
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51 Participants
n=64 Participants
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Sex: Female, Male
Male
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13 Participants
n=64 Participants
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PRIMARY outcome
Timeframe: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)Population: Evaluable population
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.
Outcome measures
| Measure |
HArmonyCA
n=62 Participants
All treatments will be administered according to the respective label and according to an agreed upon treatment plan between the subject and Health Care Provider. If required: HarmonyCA Lidocaine will be administered at Visit 1, Juvéderm filler injections (JUVÉDERM VOLBELLA with Lidocaine, and/or JUVÉDERM VOLIFT with Lidocaine, and/or JUVÉDERM VOLUMA with Lidocaine, and/or JUVÉDERM VOLITE with Lidocaine and/or JUVÉDERM VOLUX with Lidocaine) will be administered at Visit 3, BOTOX will be administered at Visit 5. Touch-ups may be performed as required by subject's treatment plan after each study visit.
Device: HArmonyCa Lidocaine injectable gel is a dermal filler intended for facial soft tissue augmentation.
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Change From Baseline in the Rasch-transformed Score of the FACE-Q Satisfaction With Facial Appearance Scale.
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46.6 units on a scale
Standard Deviation 23.61
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SECONDARY outcome
Timeframe: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)Population: Evaluable population
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.
Outcome measures
| Measure |
HArmonyCA
n=62 Participants
All treatments will be administered according to the respective label and according to an agreed upon treatment plan between the subject and Health Care Provider. If required: HarmonyCA Lidocaine will be administered at Visit 1, Juvéderm filler injections (JUVÉDERM VOLBELLA with Lidocaine, and/or JUVÉDERM VOLIFT with Lidocaine, and/or JUVÉDERM VOLUMA with Lidocaine, and/or JUVÉDERM VOLITE with Lidocaine and/or JUVÉDERM VOLUX with Lidocaine) will be administered at Visit 3, BOTOX will be administered at Visit 5. Touch-ups may be performed as required by subject's treatment plan after each study visit.
Device: HArmonyCa Lidocaine injectable gel is a dermal filler intended for facial soft tissue augmentation.
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Change From Baseline in the FACE-Q Aging Appraisal
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35.3 units on a scale
Standard Deviation 22.36
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SECONDARY outcome
Timeframe: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)Population: Evaluable population
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.
Outcome measures
| Measure |
HArmonyCA
n=62 Participants
All treatments will be administered according to the respective label and according to an agreed upon treatment plan between the subject and Health Care Provider. If required: HarmonyCA Lidocaine will be administered at Visit 1, Juvéderm filler injections (JUVÉDERM VOLBELLA with Lidocaine, and/or JUVÉDERM VOLIFT with Lidocaine, and/or JUVÉDERM VOLUMA with Lidocaine, and/or JUVÉDERM VOLITE with Lidocaine and/or JUVÉDERM VOLUX with Lidocaine) will be administered at Visit 3, BOTOX will be administered at Visit 5. Touch-ups may be performed as required by subject's treatment plan after each study visit.
Device: HArmonyCa Lidocaine injectable gel is a dermal filler intended for facial soft tissue augmentation.
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Change From Baseline in the Rasch-transformed Score of the FACE-Q Psychological Function Scale
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27.6 units on a scale
Standard Deviation 23.23
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SECONDARY outcome
Timeframe: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)Population: Evaluable population
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.
Outcome measures
| Measure |
HArmonyCA
n=62 Participants
All treatments will be administered according to the respective label and according to an agreed upon treatment plan between the subject and Health Care Provider. If required: HarmonyCA Lidocaine will be administered at Visit 1, Juvéderm filler injections (JUVÉDERM VOLBELLA with Lidocaine, and/or JUVÉDERM VOLIFT with Lidocaine, and/or JUVÉDERM VOLUMA with Lidocaine, and/or JUVÉDERM VOLITE with Lidocaine and/or JUVÉDERM VOLUX with Lidocaine) will be administered at Visit 3, BOTOX will be administered at Visit 5. Touch-ups may be performed as required by subject's treatment plan after each study visit.
Device: HArmonyCa Lidocaine injectable gel is a dermal filler intended for facial soft tissue augmentation.
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Change From Baseline in the Rasch-transformed Score of the FACE-Q Social Function Scale
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22.9 units on a scale
Standard Deviation 20.56
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SECONDARY outcome
Timeframe: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)Population: Evaluable population
The FACE-Q questionnaire is a 12- item questionnaire. Overall scores range from 0 to 100 with higher scores representing higher satisfaction.
Outcome measures
| Measure |
HArmonyCA
n=62 Participants
All treatments will be administered according to the respective label and according to an agreed upon treatment plan between the subject and Health Care Provider. If required: HarmonyCA Lidocaine will be administered at Visit 1, Juvéderm filler injections (JUVÉDERM VOLBELLA with Lidocaine, and/or JUVÉDERM VOLIFT with Lidocaine, and/or JUVÉDERM VOLUMA with Lidocaine, and/or JUVÉDERM VOLITE with Lidocaine and/or JUVÉDERM VOLUX with Lidocaine) will be administered at Visit 3, BOTOX will be administered at Visit 5. Touch-ups may be performed as required by subject's treatment plan after each study visit.
Device: HArmonyCa Lidocaine injectable gel is a dermal filler intended for facial soft tissue augmentation.
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Change From Baseline in the Rasch-transformed Score of the FACE-Q Satisfaction With Skin
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43.1 units on a scale
Standard Deviation 22.25
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SECONDARY outcome
Timeframe: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)Population: Evaluable Population
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.
Outcome measures
| Measure |
HArmonyCA
n=15 Participants
All treatments will be administered according to the respective label and according to an agreed upon treatment plan between the subject and Health Care Provider. If required: HarmonyCA Lidocaine will be administered at Visit 1, Juvéderm filler injections (JUVÉDERM VOLBELLA with Lidocaine, and/or JUVÉDERM VOLIFT with Lidocaine, and/or JUVÉDERM VOLUMA with Lidocaine, and/or JUVÉDERM VOLITE with Lidocaine and/or JUVÉDERM VOLUX with Lidocaine) will be administered at Visit 3, BOTOX will be administered at Visit 5. Touch-ups may be performed as required by subject's treatment plan after each study visit.
Device: HArmonyCa Lidocaine injectable gel is a dermal filler intended for facial soft tissue augmentation.
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Change From Baseline Self-Perception of Age
I look ___ years younger
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3.0 years
Interval 0.0 to 13.0
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Change From Baseline Self-Perception of Age
I look ___ years older
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0 years
Interval 0.0 to 0.0
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SECONDARY outcome
Timeframe: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)Population: Evaluable population
Five point ordinal scale measuring the change in facial aesthetic improvement from -2 (Much Worse) to 2 (Much Improved) assessed by the Investigator.
Outcome measures
| Measure |
HArmonyCA
n=62 Participants
All treatments will be administered according to the respective label and according to an agreed upon treatment plan between the subject and Health Care Provider. If required: HarmonyCA Lidocaine will be administered at Visit 1, Juvéderm filler injections (JUVÉDERM VOLBELLA with Lidocaine, and/or JUVÉDERM VOLIFT with Lidocaine, and/or JUVÉDERM VOLUMA with Lidocaine, and/or JUVÉDERM VOLITE with Lidocaine and/or JUVÉDERM VOLUX with Lidocaine) will be administered at Visit 3, BOTOX will be administered at Visit 5. Touch-ups may be performed as required by subject's treatment plan after each study visit.
Device: HArmonyCa Lidocaine injectable gel is a dermal filler intended for facial soft tissue augmentation.
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Investigator's Assessment Using Global Aesthetic Improvement Scale (GAIS)
Much Improved
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47 Participants
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Investigator's Assessment Using Global Aesthetic Improvement Scale (GAIS)
Improved
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15 Participants
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Investigator's Assessment Using Global Aesthetic Improvement Scale (GAIS)
No Change
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0 Participants
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Investigator's Assessment Using Global Aesthetic Improvement Scale (GAIS)
Worse
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0 Participants
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Investigator's Assessment Using Global Aesthetic Improvement Scale (GAIS)
Much Worse
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0 Participants
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
HArmonyCA
n=62 Participants
All treatments will be administered according to the respective label and according to an agreed upon treatment plan between the subject and Health Care Provider. If required: HarmonyCA Lidocaine will be administered at Visit 1, Juvéderm filler injections (JUVÉDERM VOLBELLA with Lidocaine, and/or JUVÉDERM VOLIFT with Lidocaine, and/or JUVÉDERM VOLUMA with Lidocaine, and/or JUVÉDERM VOLITE with Lidocaine and/or JUVÉDERM VOLUX with Lidocaine) will be administered at Visit 3, BOTOX will be administered at Visit 5. Touch-ups may be performed as required by subject's treatment plan after each study visit.
Device: HArmonyCa Lidocaine injectable gel is a dermal filler intended for facial soft tissue augmentation.
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Subject's Assessment Using Global Aesthetic Improvement Scale (GAIS)
No Change
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0 Participants
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Subject's Assessment Using Global Aesthetic Improvement Scale (GAIS)
Worse
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0 Participants
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Subject's Assessment Using Global Aesthetic Improvement Scale (GAIS)
Much Improved
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51 Participants
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Subject's Assessment Using Global Aesthetic Improvement Scale (GAIS)
Improved
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11 Participants
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Subject's Assessment Using Global Aesthetic Improvement Scale (GAIS)
Much Worse
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0 Participants
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SECONDARY outcome
Timeframe: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)Population: Evaluable population
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 average of the sum of transformed scores of individual items 1, 3, and 5. Score will also range from 0 to 100 with same interpretation as the total transformed score. Coping domain is the transformed score of item 9. Score will also range from 0 to 100 with same interpretation as the total transformed score.
Outcome measures
| Measure |
HArmonyCA
n=62 Participants
All treatments will be administered according to the respective label and according to an agreed upon treatment plan between the subject and Health Care Provider. If required: HarmonyCA Lidocaine will be administered at Visit 1, Juvéderm filler injections (JUVÉDERM VOLBELLA with Lidocaine, and/or JUVÉDERM VOLIFT with Lidocaine, and/or JUVÉDERM VOLUMA with Lidocaine, and/or JUVÉDERM VOLITE with Lidocaine and/or JUVÉDERM VOLUX with Lidocaine) will be administered at Visit 3, BOTOX will be administered at Visit 5. Touch-ups may be performed as required by subject's treatment plan after each study visit.
Device: HArmonyCa Lidocaine injectable gel is a dermal filler intended for facial soft tissue augmentation.
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Change From Baseline to End of Study of Periorbital Aesthetic Appearance Questionnaire (PAAQ)
Change from Baseline Appearance Domain
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-45.8 units on a scale
Interval -100.0 to 42.0
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Change From Baseline to End of Study of Periorbital Aesthetic Appearance Questionnaire (PAAQ)
Change from Baseline Transformed Total Score
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-40.3 units on a scale
Interval -86.0 to 39.0
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Change From Baseline to End of Study of Periorbital Aesthetic Appearance Questionnaire (PAAQ)
Change from Baseline Psychological Domain
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-40.0 units on a scale
Interval -90.0 to 45.0
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Change From Baseline to End of Study of Periorbital Aesthetic Appearance Questionnaire (PAAQ)
Change from Baseline Coping Domain
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-50.0 units on a scale
Interval -100.0 to 25.0
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Adverse Events
HArmonyCA
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HArmonyCA
n=64 participants at risk
All treatments will be administered according to the respective label and according to an agreed upon treatment plan between the subject and Health Care Provider. If required: HarmonyCA Lidocaine will be administered at Visit 1, Juvéderm filler injections (JUVÉDERM VOLBELLA with Lidocaine, and/or JUVÉDERM VOLIFT with Lidocaine, and/or JUVÉDERM VOLUMA with Lidocaine, and/or JUVÉDERM VOLITE with Lidocaine and/or JUVÉDERM VOLUX with Lidocaine) will be administered at Visit 3, BOTOX will be administered at Visit 5. Touch-ups may be performed as required by subject's treatment plan after each study visit.
Device: HArmonyCa Lidocaine injectable gel is a dermal filler intended for facial soft tissue augmentation.
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Infections and infestations
PYELONEPHRITIS
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1.6%
1/64 • 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 147 days for HArmonyCA.
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Musculoskeletal and connective tissue disorders
RHABDOMYOLYSIS
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1.6%
1/64 • 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 147 days for HArmonyCA.
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Other adverse events
| Measure |
HArmonyCA
n=64 participants at risk
All treatments will be administered according to the respective label and according to an agreed upon treatment plan between the subject and Health Care Provider. If required: HarmonyCA Lidocaine will be administered at Visit 1, Juvéderm filler injections (JUVÉDERM VOLBELLA with Lidocaine, and/or JUVÉDERM VOLIFT with Lidocaine, and/or JUVÉDERM VOLUMA with Lidocaine, and/or JUVÉDERM VOLITE with Lidocaine and/or JUVÉDERM VOLUX with Lidocaine) will be administered at Visit 3, BOTOX will be administered at Visit 5. Touch-ups may be performed as required by subject's treatment plan after each study visit.
Device: HArmonyCa Lidocaine injectable gel is a dermal filler intended for facial soft tissue augmentation.
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Eye disorders
PERIORBITAL OEDEMA
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1.6%
1/64 • 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 147 days for HArmonyCA.
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Gastrointestinal disorders
DIARRHOEA
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1.6%
1/64 • 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 147 days for HArmonyCA.
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Gastrointestinal disorders
LIP OEDEMA
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1.6%
1/64 • 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 147 days for HArmonyCA.
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Gastrointestinal disorders
VOMITING
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1.6%
1/64 • 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 147 days for HArmonyCA.
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General disorders
INJECTION SITE BRUISING
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1.6%
1/64 • 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 147 days for HArmonyCA.
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General disorders
INJECTION SITE INDURATION
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1.6%
1/64 • 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 147 days for HArmonyCA.
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General disorders
INJECTION SITE NODULE
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1.6%
1/64 • 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 147 days for HArmonyCA.
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General disorders
INJECTION SITE OEDEMA
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3.1%
2/64 • Number of events 3 • 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.
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General disorders
OEDEMA PERIPHERAL
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1.6%
1/64 • 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 147 days for HArmonyCA.
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Infections and infestations
DENGUE FEVER
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1.6%
1/64 • 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 147 days for HArmonyCA.
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Infections and infestations
GASTROENTERITIS VIRAL
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1.6%
1/64 • 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 147 days for HArmonyCA.
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Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
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1.6%
1/64 • 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 147 days for HArmonyCA.
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Metabolism and nutrition disorders
HYPOGLYCAEMIA
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1.6%
1/64 • 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 147 days for HArmonyCA.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place