Combination Facial Aesthetic Treatment in Millennials

NCT ID: NCT04755595

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-09
• Study Completion Date: 2021-05-19

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).

Conditions

Dermatological Non-Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Botox Cosmetic Injectable Product

Intervention Type: DRUG

Acetylcholine release inhibitor and a neuromuscular blocking agent

Juvéderm Voluma XC

Intervention Type: DEVICE

Gel implants consisting of cross-linked hyaluronic acid

Juvéderm Volbella XC

Intervention Type: DEVICE

Gel implants consisting of cross-linked hyaluronic acid

Interventions

Botox Cosmetic Injectable Product

Acetylcholine release inhibitor and a neuromuscular blocking agent

Intervention Type: DRUG

Juvéderm Voluma XC

Gel implants consisting of cross-linked hyaluronic acid

Intervention Type: DEVICE

Juvéderm Volbella XC

Gel implants consisting of cross-linked hyaluronic acid

Intervention Type: DEVICE

Other Intervention Names

onabotulinumtoxinA

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

• Minimum Eligible Age: 24 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Allergan Sales, LLC

INDUSTRY

Sponsor Role: collaborator

State University of New York - Downstate Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jared Jagdeo, MD, MS

Associate Professor of Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jared Jagdeo, MD, MS

Role: PRINCIPAL_INVESTIGATOR

SUNY Downstate Medical School

Locations

SUNY Downstate Health Sciences University

Brooklyn, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1547415

Identifier Type: -

Identifier Source: org_study_id