Combination Facial Aesthetic Treatment in Millennials

NCT04755595 | Completed Phase 2 Results FDA Drug FDA Device

• 1 other identifier: 1547415
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatological Non-Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 2 months after the procedure

Secondary Outcomes (9)

• FACE-Q Appraisal of Lines Overall

  Baseline and 2 months after the procedure

• FACE-Q Expectations Scale

  At baseline

• FACE-Q Social Function Scale

  Baseline and 2 months after the procedure

• FACE-Q Patient-Perceived Age Visual Analogue Scale

  Baseline and 2 months after the procedure

• FACE-Q Satisfaction With Cheeks

  Baseline and 2 months after the procedure

Study Arms (1)

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.

Drug: Botox Cosmetic Injectable Product; Device: Juvéderm Voluma XC; Device: Juvéderm Volbella XC

Interventions

Botox Cosmetic Injectable Product DRUG

Acetylcholine release inhibitor and a neuromuscular blocking agent

Also known as: onabotulinumtoxinA

Facial aesthetic treatment

Juvéderm Voluma XC DEVICE

Gel implants consisting of cross-linked hyaluronic acid

Facial aesthetic treatment

Juvéderm Volbella XC DEVICE

Gel implants consisting of cross-linked hyaluronic acid

Facial aesthetic treatment

Eligibility Criteria

• Age: 24 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York - Downstate Medical Center: lead
• Allergan Sales, LLC: collaborator

Study Sites (1)

SUNY Downstate Health Sciences University

Brooklyn, New York, 11203, United States

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Jared Jagdeo MD, MS
• Organization: SUNY Downstate Health Sciences University

jared.jagdeo@downstate.edu

(718) 270-1229

Study Officials

• Jared Jagdeo, MD, MS

  SUNY Downstate Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Dermatology

Model Details: 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.

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 16, 2021
• Study Start: March 9, 2021
• Primary Completion: May 19, 2021
• Study Completion: May 19, 2021
• Last Updated: January 14, 2025
• Results First Posted: September 24, 2021

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)