Dermatological Non-DiseasePhase 2NCT04755595
Combination Facial Aesthetic Treatment in Millennials
A Phase 2 study testing Botox Cosmetic Injectable Product, Juvéderm Voluma XC and Juvéderm Volbella XC in people with Dermatological Non-Disease, run by State University of New York - Downstate Medical Center at 1 site in United States.
Trial summary
With 63% of consumers willing to consider investing in facial aesthetics and 73% of consumers worldwide expecting to invest in aesthetic treatments in the upcoming year, it is imperative to explore patient satisfaction and psychosocial impact of a multimodal aesthetic treatment in a millennial cohort. Read more about this study
- Who is it for?
- Ages 24 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatological Non-Disease
- What is being tested?
- Botox Cosmetic Injectable Product, Juvéderm Voluma XC and Juvéderm Volbella XC
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2021to 19 May 2021
- Phase
- Phase 2
- 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 24 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Date of birth between January 1, 1981 and December 31, 1996
- Naiveté to facial injections of botulinum toxin and dermal filler
- Desire to receive all three facial cosmetic injectables in the study
- Suitable candidate to receive facial injectables, as determined by clinician judgment
- Provision of written informed consent for all study procedures
- Stated willingness to comply with all study procedures and availability for the duration of the study
Who cannot join
- Desire to receive only one or two of the facial injectables
- Dermatologic or medical conditions at the injection sites that may be exacerbated by the study procedures (e.g., severe acne, active infection, open sores or lesions, history of cold sores)
- Pre-existing cardiovascular disease (e.g., heart failure, coronary artery disease)
- Pre-existing swallowing or respiratory disorders (e.g., dysphagia, asthma, COPD)
- Peripheral motor neuropathy disease, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome)
- Known hypersensitivity or allergies to any of the components of the administered drugs/devices in the study (e.g., Gram-positive bacterial proteins, lidocaine)
Show all 13Show fewer
- History of anaphylaxis or multiple severe allergies
- History of a bleeding or coagulation disorder
- Pregnant or breast-feeding
- Current and/or scheduled use of the following medications: immunosuppressants, anticoagulants (e.g., warfarin, heparin, rivaroxaban), antiplatelets (e.g., clopidogrel, ticagrelor, NSAIDs), antibiotics (e.g., aminoglycosides), anticholinergics, muscle relaxants
- Procedures or treatments to the face in the past 14 days (e.g., chemical peel, laser surgery, microdermabrasion)
- Plan to undergo elective cosmetic procedure on the face (e.g., laser surgery, plastic surgery, physician-strength chemical peel) during the study
- Any medical condition(s) that could be compromised by participating in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Downstate Health Sciences University
Brooklyn, New York, 11203
About this study
With 63% of consumers willing to consider investing in facial aesthetics and 73% of consumers worldwide expecting to invest in aesthetic treatments in the upcoming year, it is imperative to explore patient satisfaction and psychosocial impact of a multimodal aesthetic treatment in a millennial cohort. The investigators hypothesize that a combination approach to facial aesthetic treatment in a millennial cohort will result in increased patient-reported satisfaction in multiple areas, including perception of aging concerns and quality of life.
Read the detailed description
This is a single-center, prospective, rater-blinded, pilot study to evaluate patient satisfaction with facial aesthetic treatment using a combination of botulinum toxin and dermal fillers. The three types of injectables are Botox Cosmetic (onabotulinumtoxinA), Juvéderm Voluma XC (hyaluronic acid gel filler), and Juvéderm Volbella XC (hyaluronic acid gel filler). Twenty individuals who belong to the millennial generation (i.e., born between January 1, 1981 and December 31, 1996)1 and meet eligibility criteria will be enrolled. Study participants will receive all three injectables during a single procedure, with an optional touch-up treatment at 2 weeks. The primary endpoint is the change in satisfaction after facial aesthetic treatment, using the FACE-Q Satisfaction with Facial Appearance Overall Scale. Other outcome measures include various FACE-Q Aesthetic scales, digital skin imaging analysis, photographs, and rater-blinded clinical assessment using the Global Aesthetic Improvement Scale (GAIS).
- Conditions
- Dermatological Non-Disease
- Being tested
- Botox Cosmetic Injectable Product, Juvéderm Voluma XC, Juvéderm Volbella XC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botox Cosmetic Injectable ProductDrug
Also called onabotulinumtoxinA
Acetylcholine release inhibitor and a neuromuscular blocking agent
Juvéderm Voluma XCDevice
Gel implants consisting of cross-linked hyaluronic acid
Juvéderm Volbella XCDevice
Gel implants consisting of cross-linked hyaluronic acid
| Study group | Role | What they receive |
|---|---|---|
| Facial aesthetic treatment | Experimental | 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. Receives: Drug: Botox Cosmetic Injectable Product; Device: Juvéderm Voluma XC; Device: Juvéderm Volbella XC |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACE-Q Satisfaction With Facial Appearance Overall Scale
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.
Measured: Baseline and 2 months after the procedure
Secondary outcomes (9)
FACE-Q Appraisal of Lines Overall
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.
Measured: Baseline and 2 months after the procedure
FACE-Q Expectations Scale
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.
Measured: At baseline
FACE-Q Social Function Scale
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.
Measured: Baseline and 2 months after the procedure
FACE-Q Patient-Perceived Age Visual Analogue Scale
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.
Measured: Baseline and 2 months after the procedure
FACE-Q Satisfaction With Cheeks
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.
Measured: Baseline and 2 months after the procedure
FACE-Q Satisfaction With Outcome Scale
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.
Measured: 2 months after the procedure
FACE-Q Psychological Function Scale
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.
Measured: Baseline and 2 months after the procedure
FACE-Q Aging Appraisal Scale
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.
Measured: 2 months after the procedure compared to baseline
FACE-Q Satisfaction With Lips
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.
Measured: Baseline and 2 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start9 Mar 2021
- Primary completion19 May 2021
- Study completion19 May 2021
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 Dermatological Non-DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-center, prospective, rater-blinded, pilot study to evaluate patient satisfaction with facial aesthetic treatment using a combination of botulinum toxin and dermal fillers. The three types of injectables are Botox Cosmetic (onabotulinumtoxinA), Juvéderm Voluma XC (hyaluronic acid gel filler), and Juvéderm Volbella XC (hyaluronic acid gel filler). Twenty individuals who belong to the millennial generation and meet eligibility criteria will be enrolled. Study participants will receive all three injectables during a single procedure. The primary endpoint is the change in satisfaction after facial aesthetic treatment, using the FACE-Q Satisfaction with Facial Appearance Overall Scale.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Downstate Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan Sales, LLC
- Responsible party
- Principal investigator, Jared Jagdeo, MD, MS, State University of New York - Downstate Medical Center
- Investigators
- Jared Jagdeo, MD, MS, Principal investigator, SUNY Downstate Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755595
- Sponsor's protocol ID
- 1547415
- Status last verified
- Dec 2024
- First submitted
- 25 Jan 2021
- Last updated
- 14 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Facial Aesthetic Treatment in Millennials
- ClinicalTrials.gov ID
- NCT04755595
- Acronym / sponsor ID
- 1547415
- Conditions
- Dermatological Non-Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- State University of New York - Downstate Medical CenterUniversity, hospital or other
- Collaborators
- Allergan Sales, LLC
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 19 May 2021 (actual)
- Study completion
- 19 May 2021 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Posted 24 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With 63% of consumers willing to consider investing in facial aesthetics and 73% of consumers worldwide expecting to invest in aesthetic treatments in the upcoming year, it is imperative to explore patient satisfaction and psychosocial impact of a multimodal aesthetic treatment in a millennial cohort. The investigators hypothesize that a combination approach to facial aesthetic treatment in a millennial cohort will result in increased patient-reported satisfaction in multiple areas, including perception of aging concerns and quality of life.
Detailed description
This is a single-center, prospective, rater-blinded, pilot study to evaluate patient satisfaction with facial aesthetic treatment using a combination of botulinum toxin and dermal fillers. The three types of injectables are Botox Cosmetic (onabotulinumtoxinA), Juvéderm Voluma XC (hyaluronic acid gel filler), and Juvéderm Volbella XC (hyaluronic acid gel filler). Twenty individuals who belong to the millennial generation (i.e., born between January 1, 1981 and December 31, 1996)1 and meet eligibility criteria will be enrolled. Study participants will receive all three injectables during a single procedure, with an optional touch-up treatment at 2 weeks. The primary endpoint is the change in satisfaction after facial aesthetic treatment, using the FACE-Q Satisfaction with Facial Appearance Overall Scale. Other outcome measures include various FACE-Q Aesthetic scales, digital skin imaging analysis, photographs, and rater-blinded clinical assessment using the Global Aesthetic Improvement Scale (GAIS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-center, prospective, rater-blinded, pilot study to evaluate patient satisfaction with facial aesthetic treatment using a combination of botulinum toxin and dermal fillers. The three types of injectables are Botox Cosmetic (onabotulinumtoxinA), Juvéderm Voluma XC (hyaluronic acid gel filler), and Juvéderm Volbella XC (hyaluronic acid gel filler). Twenty individuals who belong to the millennial generation and meet eligibility criteria will be enrolled. Study participants will receive all three injectables during a single procedure. The primary endpoint is the change in satisfaction after facial aesthetic treatment, using the FACE-Q Satisfaction with Facial Appearance Overall Scale.
| Arm | Type | Receives |
|---|---|---|
| Facial aesthetic treatment | Experimental | Drug: Botox Cosmetic Injectable Product, Device: Juvéderm Voluma XC, Device: Juvéderm Volbella XCStudy 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. |
Who may qualify
- Ages
- 24 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Date of birth between January 1, 1981 and December 31, 1996
- Naiveté to facial injections of botulinum toxin and dermal filler
- Desire to receive all three facial cosmetic injectables in the study
- Suitable candidate to receive facial injectables, as determined by clinician judgment
- Provision of written informed consent for all study procedures
Key exclusion criteria (13 listed)
- Desire to receive only one or two of the facial injectables
- Dermatologic or medical conditions at the injection sites that may be exacerbated by the study procedures (e.g., severe acne, active infection, open sores or lesions, history of cold sores)
- Pre-existing cardiovascular disease (e.g., heart failure, coronary artery disease)
- Pre-existing swallowing or respiratory disorders (e.g., dysphagia, asthma, COPD)
- Peripheral motor neuropathy disease, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome)
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 |
|---|---|---|
| Botox Cosmetic Injectable ProductAlso: onabotulinumtoxinAAcetylcholine release inhibitor and a neuromuscular blocking agent | Drug | Facial aesthetic treatment |
| Juvéderm Voluma XCGel implants consisting of cross-linked hyaluronic acid | Device | Facial aesthetic treatment |
| Juvéderm Volbella XCGel implants consisting of cross-linked hyaluronic acid | Device | Facial aesthetic treatment |
Primary outcome
FACE-Q Satisfaction With Facial Appearance Overall Scale
Time frame: 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.
9 secondary outcomes
FACE-Q Appraisal of Lines Overall
Time frame: Baseline and 2 months after the procedure
FACE-Q Expectations Scale
Time frame: At baseline
FACE-Q Social Function Scale
Time frame: Baseline and 2 months after the procedure
FACE-Q Patient-Perceived Age Visual Analogue Scale
Time frame: Baseline and 2 months after the procedure
FACE-Q Satisfaction With Cheeks
Time frame: Baseline and 2 months after the procedure
FACE-Q Satisfaction With Outcome Scale
Time frame: 2 months after the procedure
FACE-Q Psychological Function Scale
Time frame: Baseline and 2 months after the procedure
FACE-Q Aging Appraisal Scale
Time frame: 2 months after the procedure compared to baseline
FACE-Q Satisfaction With Lips
Time frame: Baseline and 2 months after the procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jared Jagdeo, MD, MS principal investigator
SUNY Downstate Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botox Cosmetic Injectable Product, Juvéderm Voluma XC and Juvéderm Volbella XC in people with Dermatological Non-Disease, run by State University of New York - Downstate Medical Center at 1 site in United States.
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 6 inclusion and 13 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 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 24 Sep 2021). 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?
FACE-Q Satisfaction With Facial Appearance Overall Scale (time frame: Baseline and 2 months after the procedure). 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 14 Jan 2025.