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

NCT02312154 | Completed Phase 4 Results DMC

• 1 other identifier: KUH1120048
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aging

Outcome Measures

Primary Outcomes (6)

• Hydration Level

  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

  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

  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

  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)

  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)

  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

Study Arms (2)

treated side (Restylane vital)

EXPERIMENTAL

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

untreated side (control)

NO INTERVENTION

We did nothing on the right side of face and we compared the results on same participants

Interventions

Restylane Vital DEVICE

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

treated side (Restylane vital)

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy people older than 25 years

You may not qualify if:

• known hypersensitivity to HA, an active skin disease, any autoimmune disorder, or significant renal, hepatic, or other medical diseases

Sponsors & Collaborators

• Konkuk University Hospital: lead

Related Publications (17)

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  PMID: 19730872 BACKGROUND

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• Bachmann F, Erdmann R, Hartmann V, Wiest L, Rzany B. The spectrum of adverse reactions after treatment with injectable fillers in the glabellar region: results from the Injectable Filler Safety Study. Dermatol Surg. 2009 Oct;35 Suppl 2:1629-34. doi: 10.1111/j.1524-4725.2009.01341.x.

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  PMID: 21896135 BACKGROUND

• Roh NK, Kim MJ, Lee YW, Choe YB, Ahn KJ. A Split-Face Study of the Effects of a Stabilized Hyaluronic Acid-Based Gel of Nonanimal Origin for Facial Skin Rejuvenation Using a Stamp-Type Multineedle Injector: A Randomized Clinical Trial. Plast Reconstr Surg. 2016 Mar;137(3):809-816. doi: 10.1097/01.prs.0000480686.68275.60.

  PMID: 26910661 DERIVED

Limitations and Caveats

First, it did not have a double-blind design, and so the GAIS scores of the subjects could have been influenced. Second, the posttreatment follow-up period was relatively short, at 12 weeks. Finally, the patient sample in this study was small.

Results Point of Contact

• Title: Yang Won Lee
• Organization: Konkuk University

20130112@kuh.ac.kr

8220305172

Study Officials

• Yang Won Lee, MD, PhD

  Department of Dermatology, Konkuk University School of Medicine, Seoul, Korea

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 9, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 3, 2015
• Results First Posted: February 24, 2015

Record last verified: 2015-03