Phase 4
N=25
Changing in Skin Physiology After Microdroplet Placement of Stabilized Hyaluronic Acid in Aging Faces
Aging
Bottom Line
View on ClinicalTrials.gov: NCT02312154 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Hydration Level — 53.19; 46.75 AU (arbitrary unit) — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Restylane Vital (Device)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Konkuk University Hospital
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hydration Level |
53.19; 46.75 | <0.05 sig |
| PRIMARY Elasticity |
242.33; 271.15 | <0.05 sig |
| PRIMARY Melanin Index |
147.25; 149.00 | <0.05 sig |
| PRIMARY Erythema Index |
253.66; 243.53 | <0.05 sig |
| PRIMARY Global Aesthetic Improvement Scale (Investigator) |
1.38; 0 | <0.05 sig |
| PRIMARY Global Aesthetic Improvement Scale (Subject) |
1.33; 0 | <0.05 sig |
Summary
IMPORTANCE Skin rejuvenation can be achieved effectively and safely by injection of a stabilized hyaluronic acid (HA)-based gel of nonanimal origin (NASHA) injection using a stamp-type electronic multineedle injector.
OBJECTIVE To determine the efficacy and safety of NASHA using a stamp-type electronic multineedle injector, and if changes in skin physiology occur earlier than in previous trials.
DESIGN, SETTING, AND PARTICIPANTS Twenty-five patients were recruited to this single-center, evaluator-blinded, prospective, balanced (1:1), split-face randomized clinical trial.One dermatologist who was blinded as to the treatment side evaluated the skin hydration, melanin content, erythema, and elasticity of both cheeks using a corneometer, a mexameter, and a reviscometer, respectively, at each follow-up visit (0, 1, 2, 4, 8, and 12 weeks postinjection). The subjects and two independent investigators assessed the clinical improvement using the Global Aesthetic Improvement Scale (GAIS) at the every visit. Twenty-four participants completed the study, and no participants withdrew due to adverse effects.
INTERVENTIONS Each participant submitted to a single treatment with a NASHA injection to one side of the lower cheek. The cheek side to which the treatment was applied was chosen randomly.
Eligibility Criteria
Inclusion Criteria
- Healthy people older than 25 years
Exclusion Criteria
- known hypersensitivity to HA, an active skin disease, any autoimmune disorder, or significant renal, hepatic, or other medical diseases
Data sourced from ClinicalTrials.gov (NCT02312154). 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.