Clinical trial NCT04755595: Combination Facial Aesthetic Treatment in Millennials
Official title: Combination Facial Aesthetic Treatment in Millennials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dermatological Non-Disease
Lead sponsor: State University of New York - Downstate Medical Center
Sponsor class: OTHER
Collaborators: name: Allergan Sales, LLC
First posted: 2021-02-16
Enrollment: 20
Sex: ALL
Minimum age (years): 24
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
measure: FACE-Q Satisfaction With Facial Appearance Overall Scale
timeFrame: Baseline and 2 months after the procedure
Secondary outcomes:
measure: FACE-Q Appraisal of Lines Overall
timeFrame: Baseline and 2 months after the procedure
measure: FACE-Q Expectations Scale
timeFrame: At baseline
measure: FACE-Q Social Function Scale
timeFrame: Baseline and 2 months after the procedure
measure: FACE-Q Patient-Perceived Age Visual Analogue Scale
timeFrame: Baseline and 2 months after the procedure
measure: FACE-Q Satisfaction With Cheeks
timeFrame: Baseline and 2 months after the procedure
measure: FACE-Q Satisfaction With Outcome Scale
timeFrame: 2 months after the procedure
measure: FACE-Q Psychological Function Scale
timeFrame: Baseline and 2 months after the procedure
measure: FACE-Q Aging Appraisal Scale
timeFrame: 2 months after the procedure compared to baseline
measure: FACE-Q Satisfaction With Lips
timeFrame: Baseline and 2 months after the procedure
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: SUNY Downstate Health Sciences University
state: New York
Study officials:
affiliation: SUNY Downstate Medical School
name: Jared Jagdeo, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: