A Phase 4 interventional study of JUVÉDERM and BOTOX in Facial Rhytides, Skin Folds and Loss of Volume and Skin Quality, sponsored by Allergan. Completed at 6 sites in Brazil. Open to participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-06-17.
Sponsored by Allergan (part of AbbVie) · Phase 4, Interventional, and Treatment
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
Allergan is the lead sponsor of 505 studies on the registry; none are open to participants now.
Of its 93 completed or terminated interventional studies of FDA-regulated products, 91 (98%) have results posted.
First submitted after Allergan became part of AbbVie.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Must qualify to receive BOTOX treatments, in at least one area, as per the approved Product Monograph including treatment of hyperkinetic lines for the glabellar, crow's feet, and forehead lines:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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: JUVÉDERM · Drug: BOTOX · Device: HArmonyCA Lidocaine
JUVÉDERM VOLBELLA with Lidocaine Treatment of any fine lines and medium-sized skin depressions. Can also be used for enhancement and pouting of the lips to correct structural defects such as asymmetry, contour deformities, volume loss. JUVÉDERM VOLIFT with Lidocaine Intended for the treatment of any deep skin depressions due to conditions such as premature aging. Can also be used for face contouring and volume restoration to correct facial structural defects such as asymmetry, contour deformities, volume loss in the lips, cheeks, chin, lower face. JUVÉDERM VOLUMA with Lidocaine Intended to restore volume of the face JUVÉDERM VOLITE with Lidocaine Intended for treatment, by filling, of superficial cutaneous depressions such as fine lines and for additional improvement of skin quality attributes such as hydration and elasticity. JUVÉDERM VOLUX with Lidocaine Intended to restore and generate facial volume in chin and mandible areas
Indicated for the treatment of hyperkinetic facial lines.
HArmonyCa Lidocaine injectable gel is a dermal filler intended for facial soft tissue augmentation.
Change From Baseline in the Rasch-transformed Score of the FACE-Q Satisfaction With Facial Appearance Scale.
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.
Time frame: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)
Change From Baseline in the FACE-Q Aging Appraisal
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.
Time frame: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)
Change From Baseline in the Rasch-transformed Score of the FACE-Q Psychological Function Scale
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.
Time frame: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)
Change From Baseline in the Rasch-transformed Score of the FACE-Q Social Function Scale
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.
Time frame: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)
Change From Baseline in the Rasch-transformed Score of the FACE-Q Satisfaction With Skin
The FACE-Q questionnaire is a 12- item questionnaire. Overall scores range from 0 to 100 with higher scores representing higher satisfaction.
Time frame: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)
Change From Baseline Self-Perception of Age
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.
Time frame: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)
Investigator's Assessment Using Global Aesthetic Improvement Scale (GAIS)
Five point ordinal scale measuring the change in facial aesthetic improvement from -2 (Much Worse) to 2 (Much Improved) assessed by the Investigator.
Time frame: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)
Subject's Assessment Using Global Aesthetic Improvement Scale (GAIS)
Five point ordinal scale measuring the change in facial aesthetic improvement from -2 (Much Worse) to 2 (Much Improved) assessed by the subject.
Time frame: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)
Change From Baseline to End of Study of Periorbital Aesthetic Appearance Questionnaire (PAAQ)
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.
Time frame: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)
| Milestone | HArmonyCA |
|---|---|
| Started | 64 |
| Completed | 64 |
| Not completed | 0 |
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.
| units on a scale | HArmonyCA |
|---|---|
| Change From Baseline in the Rasch-transformed Score of the FACE-Q Satisfaction With Facial Appearance Scale. | 46.6 ± 23.61 |
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.
| units on a scale | HArmonyCA |
|---|---|
| Change From Baseline in the FACE-Q Aging Appraisal | 35.3 ± 22.36 |
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.
| units on a scale | HArmonyCA |
|---|---|
| Change From Baseline in the Rasch-transformed Score of the FACE-Q Psychological Function Scale | 27.6 ± 23.23 |
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.
| units on a scale | HArmonyCA |
|---|---|
| Change From Baseline in the Rasch-transformed Score of the FACE-Q Social Function Scale | 22.9 ± 20.56 |
The FACE-Q questionnaire is a 12- item questionnaire. Overall scores range from 0 to 100 with higher scores representing higher satisfaction.
| units on a scale | HArmonyCA |
|---|---|
| Change From Baseline in the Rasch-transformed Score of the FACE-Q Satisfaction With Skin | 43.1 ± 22.25 |
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.
| years | HArmonyCA |
|---|---|
| I look ___ years younger | 3.0 (0 to 13) |
| I look ___ years older | 0 (0 to 0) |
Five point ordinal scale measuring the change in facial aesthetic improvement from -2 (Much Worse) to 2 (Much Improved) assessed by the Investigator.
| Participants | HArmonyCA |
|---|---|
| Much Improved | 47 |
| Improved | 15 |
| No Change | 0 |
| Worse | 0 |
| Much Worse | 0 |
Five point ordinal scale measuring the change in facial aesthetic improvement from -2 (Much Worse) to 2 (Much Improved) assessed by the subject.
| Participants | HArmonyCA |
|---|---|
| Much Improved | 51 |
| Improved | 11 |
| No Change | 0 |
| Worse | 0 |
| Much Worse | 0 |
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.
| units on a scale | HArmonyCA |
|---|---|
| Change from Baseline Transformed Total Score | -40.3 (-86 to 39) |
| Change from Baseline Psychological Domain | -40.0 (-90 to 45) |
| Change from Baseline Appearance Domain | -45.8 (-100 to 42) |
| Change from Baseline Coping Domain | -50.0 (-100 to 25) |
Collected over 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.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HArmonyCA | 0/64 (0%) | 2/64 (3.1%) | 8/64 (12.5%) |
| Event | HArmonyCA |
|---|---|
| PYELONEPHRITISInfections and infestations | 1/64 |
| RHABDOMYOLYSISMusculoskeletal and connective tissue disorders | 1/64 |
| Event | HArmonyCA |
|---|---|
| INJECTION SITE OEDEMAGeneral disorders | 2/64 |
| PERIORBITAL OEDEMAEye disorders | 1/64 |
| DIARRHOEAGastrointestinal disorders | 1/64 |
| LIP OEDEMAGastrointestinal disorders | 1/64 |
| VOMITINGGastrointestinal disorders | 1/64 |
| INJECTION SITE BRUISINGGeneral disorders | 1/64 |
| INJECTION SITE INDURATIONGeneral disorders | 1/64 |
| INJECTION SITE NODULEGeneral disorders | 1/64 |
| OEDEMA PERIPHERALGeneral disorders | 1/64 |
| DENGUE FEVERInfections and infestations | 1/64 |
| Age, Continuous(years) | HArmonyCA |
|---|---|
| Mean | 48.4 ± 7.37 |
| Sex: Female, Male(Participants) | HArmonyCA |
|---|---|
| Female | 51 |
| Male | 13 |
| Race and Ethnicity Not Collected(Participants) | HArmonyCA |
|---|
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Data sharing details ↗ · vivli.org
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