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

Phase 4

Completed

• Conditions: Aging
• Interventions: Device: Restylane Vital

• Registration Number: NCT02312154
• Lead Sponsor: Konkuk University Hospital

Brief 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.

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2014-07
• Study Completion: 2014-12
• Study First Submitted: 2014-12-05
• Study First Submitted QC: 2014-12-08
• Study First Posted: 2014-12-09
• Results First Submitted: 2014-12-09
• Results First Submitted QC: 2015-02-20
• Results First Posted: 2015-02-24
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-16
• Last Update Posted: 2015-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treated side (Restylane vital)	Restylane Vital	We injected staabilized hyaluronic acid (HA)-based gel of nonanimal origin on the left side of face. (We performed split face study)

Primary Outcome Measures

Name	Time	Method
Erythema Index	12 weeks	We measured an erythema index by a mexameter device (Courage \& Khazaka, Cologne, Germany).; The range of erythema index is 0\~999 AU(Arbitrary Unit). The range of erythema index was 0 (as non-erythematous as possible) \~999 AU (most erythematous possible)
Elasticity	12 weeks	We measured a elasticity by a reviscometer device (Courage \& Khazaka, Cologne, Germany).; The range of elasticity was 0 (most elastic possible as) \~400 AU(Arbitrary Unit) (inelastic as possible)
Global Aesthetic Improvement Scale (Investigator)	12 weeks	The therapeutic outcome was assessed by investigator using the Global Aesthetic Improvement Scale (GAIS), which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse.
Global Aesthetic Improvement Scale (Subject)	12 weeks	The therapeutic outcome was assessed by patient self-assessment using the Global Aesthetic Improvement Scale (GAIS), which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse
Hydration Level	12 weeks	We measured a hydration level by a corneometer device (Courage \& Khazaka, Cologne, Germany).; The range of hydration level was 0 (as dry as possible) \~120 AU (Arbitrary Unit)(most moist possible)
Melanin Index	12 weeks	We measured a melanin index by a mexameter device (Courage \& Khazaka, Cologne, Germany).; The range of melanin index was 0 (as bright as possible) \~999 AU (Arbitrary Unit) (most dark possible).