Phase 2
Completed N=20
Combination Facial Aesthetic Treatment in Millennials
Dermatological Non-Disease
Source: ClinicalTrials.gov NCT04755595 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcomePrimary: FACE-Q Satisfaction With Facial Appearance Overall Scale — 42.35; 59.42 score on a scale
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.
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 | — |
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
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. Informational only — not medical advice.