Combination Facial Aesthetic Treatment in Millennials

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.

Study Overview

• Status: Completed
• Conditions: Dermatological Non-Disease
• Intervention / Treatment: Drug: Botox Cosmetic Injectable Product; Device: Juvéderm Voluma XC; Device: Juvéderm Volbella XC

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11203
      • SUNY Downstate Health Sciences University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Facial aesthetic treatment; 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.	Drug: Botox Cosmetic Injectable Product; Acetylcholine release inhibitor and a neuromuscular blocking agent; Other Names: onabotulinumtoxinA; Device: Juvéderm Voluma XC; Gel implants consisting of cross-linked hyaluronic acid; Device: Juvéderm Volbella XC; Gel implants consisting of cross-linked hyaluronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in FACE-Q Satisfaction With Facial Appearance Overall Scale	To evaluate 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.	2 months after the procedure compared to baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess 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 several 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".	At baseline
Changes in 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 several 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".	2 months after the procedure compared to baseline
Changes in 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. This study participant will select 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".	2 months after the procedure compared to baseline
Changes in FACE-Q Aesthetic Scales	To assess changes in patient satisfaction with their appearance after facial aesthetic treatment, using the FACE-Q Aesthetic Scales. The tool consists of several questions regarding self-perception of facial features. For questions regarding facial lines, study participants select a number from 1 to 4, with higher numbers reflecting more bothersome lines. For questions regarding cheeks and lips, study participants select a number from 1 to 4, with higher numbers reflecting greater satisfaction with cheeks and lips.	2 months after the procedure compared to baseline
Assess 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 several 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".	2 months after the procedure
Changes in FACE-Q Psychological Function Scale	To assess changes in psychosocial factors after facial aesthetic treatment, using and FACE-Q Psychological Function Scale. This tool consists of several 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".	2 months after the procedure compared to baseline
Changes in 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 several 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".	2 months after the procedure compared to baseline

Collaborators and Investigators

• Sponsor: State University of New York - Downstate Medical Center
• Collaborators: Allergan Sales, LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 9, 2021
• Primary Completion (ACTUAL): May 19, 2021
• Study Completion (ACTUAL): May 19, 2021

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (ACTUAL): February 16, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 24, 2021
• Last Update Submitted That Met QC Criteria: August 27, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 1547415

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes