Combination Facial Aesthetic Treatment in Millennials

• Status: Completed
• Trial end date: 2021-05-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: State University of New York - Downstate Medical Center
• Collaborator: Allergan Sales, LLC
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A

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