Facial RhytidesPhase 4NCT04609020
Study to Evaluate Subject Satisfaction With Facial Appearance and Impact of Combined Facial Treatment
A Phase 4 study testing JUVÉDERM, BOTOX and HArmonyCA Lidocaine in people with Facial Rhytides and Skin Folds, run by Allergan at 6 sites in Brazil.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Facial Rhytides, Skin Folds, Loss of Volume and Skin Quality
- What is being tested?
- JUVÉDERM, BOTOX and HArmonyCA Lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 6 sitesBrazil
- Study dates
- 15 Feb 2023to 10 May 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Accept the obligation not to receive any other facial procedures or treatments at any time during the study that are not related to the study
- Women of childbearing potential must have a negative urine pregnancy test before each injectable treatment and practice a reliable method of contraception throughout the study
- Willing to avoid direct and prolonged sun exposure to the facial skin, which includes tanning beds, for the duration of the study
- 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:
- Glabellar injection: glabellar rhytides characterized as moderate or severe during maximum muscle contraction on the evaluation of the facial wrinkle scale (FWS)
- CFLs characterized as 2 (moderate) or 3 (severe) during maximum smile on the evaluation of the FWS
- Forehead lines (FHLs) of moderate to 3 severe rating at maximum eyebrow elevation as assessed using the FWS
Who cannot join
- Body mass index (BMI) > 30 kg/m2
- Known allergy or sensitivity to the study products or their components
- Pregnant, lactating, or planning to become pregnant at any time during the study
- Received BOTOX or treatment with any other botulinum toxin product for any condition within 6 months before enrollment
- Received (or is planning to receive) anti-coagulation, antiplatelet or thrombolytic medications (e.g., warfarin) or other substances known to increase coagulation time from 10 days prior to injection and up to 3 days post-injection
- Undergone plastic surgery of the face and/or neck, tissue grafting, or tissue augmentation with silicone, fat, or other permanent dermal fillers, or be planning to undergo any of these procedures at any time during the study
Show all 27Show fewer
- Has undergone temporary or semi-permanent facial or neck dermal filler treatment (e.g., hyaluronic acid, calcium hydroxylapatite, poly-L-lactic acid) within 12 months before enrollment
- Received mesotherapy, skin resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or non-ablative procedures) in the face or neck within 6 months prior to study enrollment
- Marked facial asymmetry, brow or eyelid ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or an inability to substantially lessen the resting GLs and CFLs/facial rhytides by physically spreading them apart
- Lip tattoos, facial hair or scars that would interfere with visualization of the lips and perioral area for the effectiveness assessments
- At any proposed injection site, presence of inflammation, infection at any injection site or systemic infection (study entry may be postponed until one week following recovery), noticeable acne scarring, cancerous or pre-cancerous lesion, or unhealed wound or have undergone radiation treatment in the area to be treated
- Received any investigational product within 60 days prior to study enrollment or planning to participate in another investigation during the course of this study
- Current use of oral corticosteroids
- Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., aspirin, ibuprofen), from 10 days prior to injection up to 3 days post-injection
- Prescription topical retinoid therapy and/or topical hormone cream applied to the face, for potential subjects who have not been on a consistent dose regimen for at least 6 months prior to enrollment and who are unable to maintain regimen for the study
- Systemic retinoid therapy within one year prior to study enrollment
- History or current symptoms of dysphagia
- Medical condition that may increase the risk of exposure to botulinum toxin including diagnosed myasthenia gravis, Eaton-Lambert Syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function
- Profound atrophy/excessive weakness of muscles in target areas of injection
- History of facial nerve palsy
- Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study treatment)
- Very thin skin in the mid-facial region
- Tendency to accumulate fluid in the lower eyelids, or large infraorbital fat pads, i.e., significant convexity or projection from the infraorbital fat pads
- Mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases such as generalized lipodystrophy (e.g., juvenile dermatomyositis), partial lipodystrophy (e.g., Barraquer-Simons syndrome), inherited disease, or human immunodeficiency virus-related disease
- Undergone oral surgery or other dental procedures (e.g., tooth extraction, orthodontia, or implantation) within 30 days prior to enrollment or be planning to undergo any of these procedures during the study
- Subjects with neuromuscular disorders including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise
- Subjects with a history of allergies
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Brazil6 sites
Hospital Regional da Asa Norte - Brasilia /ID# 239161
Brasília, Federal District, 70710-100
Hospital do Servidor Publico Municipal - Sao Paulo /ID# 239165
Niterói, Rio de Janeiro, 24230-052
Universidade de Sao Paulo - Sao Paulo /ID# 239163
Rio de Janeiro, 22440-032
Dermick Clinica de Dermatologia - Niteroi/Rio de Janeiro /ID# 239166
São Paulo, 04004-030
BRAVOMED Dermatology - Rio de Janeiro /ID# 239160
São Paulo, 04023-062
Universidade Federal de Sao Paulo - Sao Paulo /ID# 239156
São Paulo, 05005-001
About this study
Official title: Prospective, Multi-site Study to Evaluate Subject Satisfaction With Facial Appearance Overall and the Aesthetic and Psychosocial Impact of Combined Facial 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
- Conditions
- Facial Rhytides, Skin Folds, Loss of Volume and Skin Quality
- Being tested
- JUVÉDERM, BOTOX, HArmonyCA Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JUVÉDERMDevice
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
BOTOXDrug
Indicated for the treatment of hyperkinetic facial lines.
HArmonyCA LidocaineDevice
HArmonyCa Lidocaine injectable gel is a dermal filler intended for facial soft tissue augmentation.
| Study group | Role | What they receive |
|---|---|---|
| HArmonyCA, Juvederm, BOTOX | Experimental | 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. Receives: Device: JUVÉDERM; Drug: BOTOX; Device: HArmonyCA Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start15 Feb 2023
- Primary completion10 May 2024
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Facial RhytidesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ALLERGAN INC., Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609020
- Sponsor's protocol ID
- CMO-MA-FAS-0580
- Status last verified
- Jun 2025
- First submitted
- 6 Oct 2020
- Last updated
- 17 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-site Study to Evaluate Subject Satisfaction With Facial Appearance Overall and the Aesthetic and Psychosocial Impact of Combined Facial Treatment
- ClinicalTrials.gov ID
- NCT04609020
- Acronym / sponsor ID
- CMO-MA-FAS-0580
- Conditions
- Facial Rhytides, Skin Folds, Loss of Volume and Skin Quality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 30 Oct 2020 (actual)
- Results
- Posted 17 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HArmonyCA, Juvederm, BOTOX | Experimental | Device: JUVÉDERM, Drug: BOTOX, Device: HArmonyCA LidocaineAll 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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Accept the obligation not to receive any other facial procedures or treatments at any time during the study that are not related to the study
- Women of childbearing potential must have a negative urine pregnancy test before each injectable treatment and practice a reliable method of contraception throughout the study
- Willing to avoid direct and prolonged sun exposure to the facial skin, which includes tanning beds, for the duration of the study
- 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:
Key exclusion criteria (27 listed)
- Body mass index (BMI) > 30 kg/m2
- Known allergy or sensitivity to the study products or their components
- Pregnant, lactating, or planning to become pregnant at any time during the study
- Received BOTOX or treatment with any other botulinum toxin product for any condition within 6 months before enrollment
- Received (or is planning to receive) anti-coagulation, antiplatelet or thrombolytic medications (e.g., warfarin) or other substances known to increase coagulation time from 10 days prior to injection and up to 3 days post-injection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JUVÉDERMJUVÉDERM 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 | Device | HArmonyCA, Juvederm, BOTOX |
| BOTOXIndicated for the treatment of hyperkinetic facial lines. | Drug | HArmonyCA, Juvederm, BOTOX |
| HArmonyCA LidocaineHArmonyCa Lidocaine injectable gel is a dermal filler intended for facial soft tissue augmentation. | Device | HArmonyCA, Juvederm, BOTOX |
Primary outcome
Change From Baseline in the Rasch-transformed Score of the FACE-Q Satisfaction With Facial Appearance Scale.
Time frame: 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.
8 secondary outcomes
Change From Baseline in the FACE-Q Aging Appraisal
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
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
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
Time frame: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)
Change From Baseline Self-Perception of Age
Time frame: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)
Investigator's Assessment Using Global Aesthetic Improvement Scale (GAIS)
Time frame: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)
Subject's Assessment Using Global Aesthetic Improvement Scale (GAIS)
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)
Time frame: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ALLERGAN INC. study director
Allergan
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing JUVÉDERM, BOTOX and HArmonyCA Lidocaine in people with Facial Rhytides and Skin Folds, run by Allergan at 6 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Rasch-transformed Score of the FACE-Q Satisfaction With Facial Appearance Scale. (time frame: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.