NCT04755595

Combination Facial Aesthetic Treatment in Millennials

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: State University of New York - Downstate Medical Center · Academic / Other
• Sex: All
• Age: 24 Years – 40 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Botox Cosmetic Injectable Product	Acetylcholine release inhibitor and a neuromuscular blocking agent
DEVICE	Juvéderm Voluma XC	Gel implants consisting of cross-linked hyaluronic acid
DEVICE	Juvéderm Volbella XC	Gel implants consisting of cross-linked hyaluronic acid

Timeline

• Start date: 2021-03-09
• Primary completion: 2021-05-19
• Completion: 2021-05-19
• First posted: 2021-02-16
• Last updated: 2025-01-14
• Results posted: 2021-09-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study