NCT02312154

Changing in Skin Physiology After Microdroplet Placement of Stabilized Hyaluronic Acid in Aging Faces

Split-face Study of Changing in Skin Physiology and Clinical Appearance After Microdroplet Placement of Stabilized Hyaluronic Acid in Aging Faces

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Konkuk University Hospital · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Accepted

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.

Detailed description

Twenty-five patients were recruited to this single-center, evaluator-blinded, prospective, balanced (1:1), split-face randomized clinical trial. Twenty-four participants completed the study, and no participants withdrew due to adverse effects. Each participant submitted to a single treatment with a NASHA injection to one side of the lower cheek. 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. Adverse events were self-reported by the patients completing a questionnaire.

Conditions

• Aging

Interventions

Type	Name	Description
DEVICE	Restylane Vital	stabilized hyaluronic acid (HA)-based gel of nonanimal origin

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-07-01
• Completion: 2014-12-01
• First posted: 2014-12-09
• Last updated: 2015-04-03
• Results posted: 2015-02-24