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

March 16, 2015 updated by: Yang Won Lee, Konkuk University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treated side (Restylane vital)

We injected staabilized hyaluronic acid (HA)-based gel of nonanimal origin on the left side of face.

(We performed split face study)
Device: Restylane Vital
stabilized hyaluronic acid (HA)-based gel of nonanimal origin
No Intervention: untreated side (control)
We did nothing on the right side of face and we compared the results on same participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hydration Level
Time Frame: 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)
12 weeks
Elasticity
Time Frame: 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)
12 weeks
Melanin Index
Time Frame: 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).
12 weeks
Erythema Index
Time Frame: 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)
12 weeks
Global Aesthetic Improvement Scale (Investigator)
Time Frame: 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.
12 weeks
Global Aesthetic Improvement Scale (Subject)
Time Frame: 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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konkuk University Hospital

Investigators

  • Principal Investigator: Yang Won Lee, MD, PhD, Department of Dermatology, Konkuk University School of Medicine, Seoul, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

December 5, 2014

First Submitted That Met QC Criteria

December 8, 2014

First Posted (Estimate)

December 9, 2014

Study Record Updates

Last Update Posted (Estimate)

April 3, 2015

Last Update Submitted That Met QC Criteria

March 16, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • KUH1120048

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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