Combination Facial Aesthetic Treatment in Millennials

State University of New York - Downstate Medical Center20 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dermatological Non-Disease

Interventions

Botox Cosmetic Injectable ProductDRUG

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

Eligibility

Sex: ALLMin age: 24 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

SUNY Downstate Health Sciences University

Brooklyn, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline and 2 months after the procedure

Secondary Outcomes

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.

Time frame: 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.

Time frame: At baseline

Data from ClinicalTrials.gov

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