Status:
COMPLETED
Combination Facial Aesthetic Treatment in Millennials
Lead Sponsor:
State University of New York - Downstate Medical Center
Collaborating Sponsors:
Allergan Sales, LLC
Conditions:
Dermatological Non-Disease
Eligibility:
All Genders
24-40 years
Phase:
PHASE2
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 pa...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04755595
Start Date
March 9 2021
End Date
May 19 2021
Last Update
January 14 2025
Active Locations (1)
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1
SUNY Downstate Health Sciences University
Brooklyn, New York, United States, 11203