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Completed

NCT Number: NCT02312154

Changing in Skin Physiology 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.

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Key information

Conditions

Aging

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Restylane Vital

Device

stabilized hyaluronic acid (HA)-based gel of nonanimal origin

Primary outcomes

  1. 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)

  2. 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)

  3. 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).

  4. 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)

  5. 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.

  6. 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

Sponsors and collaborators

Lead sponsor

Konkuk University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Dec 9, 2014
Registry last updated
Apr 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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