Phase 2 N=20 Treatment

Combination Facial Aesthetic Treatment in Millennials

Dermatological Non-Disease

Bottom Line

View on ClinicalTrials.gov: NCT04755595 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2021

Primary outcome: Primary: FACE-Q Satisfaction With Facial Appearance Overall Scale — 42.35; 59.42 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Botox Cosmetic Injectable Product (Drug); Juvéderm Voluma XC (Device); Juvéderm Volbella XC (Device)
Age: Adult · 24+ yrs
Sex: All
Sponsor: State University of New York - Downstate Medical Center
Primary completion: May 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY FACE-Q Satisfaction With Facial Appearance Overall Scale	42.35; 59.42	—
SECONDARY FACE-Q Appraisal of Lines Overall	21.5; 15.1	—
SECONDARY FACE-Q Expectations Scale	17.4	—
SECONDARY FACE-Q Social Function Scale	24.4; 27.4	—
SECONDARY FACE-Q Patient-Perceived Age Visual Analogue Scale	0.2; -2.2	—
SECONDARY FACE-Q Satisfaction With Cheeks	13.3; 16.9	—
SECONDARY FACE-Q Satisfaction With Outcome Scale	20.8	—
SECONDARY FACE-Q Psychological Function Scale	30.5; 34.9	—
SECONDARY FACE-Q Aging Appraisal Scale	12.6; 9.8	—
SECONDARY FACE-Q Satisfaction With Lips	25.4; 34.9	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04755595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.