Clinical trial NCT02312154: Changing in Skin Physiology After Microdroplet Placement of Stabilized Hyaluronic Acid in Aging Faces
Official title: Split-face Study of Changing in Skin Physiology and Clinical Appearance After Microdroplet Placement of Stabilized Hyaluronic Acid in Aging Faces
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Aging
Lead sponsor: Konkuk University Hospital
Sponsor class: OTHER
First posted: 2014-12-09
Enrollment: 25
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hydration Level
timeFrame: 12 weeks
measure: Elasticity
timeFrame: 12 weeks
measure: Melanin Index
timeFrame: 12 weeks
measure: Erythema Index
timeFrame: 12 weeks
measure: Global Aesthetic Improvement Scale (Investigator)
timeFrame: 12 weeks
measure: Global Aesthetic Improvement Scale (Subject)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Dermatology, Konkuk University School of Medicine, Seoul, Korea
name: Yang Won Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gniadecka M, Nielsen OF, Wessel S, Heidenheim M, Christensen DH, Wulf HC. Water and protein structure in photoaged and chronically aged skin. J Invest Dermatol. 1998 Dec;111(6):1129-33. doi: 10.1046/j.1523-1747.1998.00430.x.
citation: Matarasso SL, Carruthers JD, Jewell ML; Restylane Consensus Group. Consensus recommendations for soft-tissue augmentation with nonanimal stabilized hyaluronic acid (Restylane). Plast Reconstr Surg. 2006 Mar;117(3 Suppl):3S-34S. doi: 10.1097/01.prs.0000204759.76865.39.
citation: Kerscher M, Bayrhammer J, Reuther T. Rejuvenating influence of a stabilized hyaluronic acid-based gel of nonanimal origin on facial skin aging. Dermatol Surg. 2008 May;34(5):720-6. doi: 10.1111/j.1524-4725.2008.34176.x. Epub 2008 Apr 1.
citation: Streker M, Reuther T, Krueger N, Kerscher M. Stabilized hyaluronic acid-based gel of non-animal origin for skin rejuvenation: face, hand, and decolletage. J Drugs Dermatol. 2013 Sep;12(9):990-4.
citation: Naylor EC, Watson RE, Sherratt MJ. Molecular aspects of skin ageing. Maturitas. 2011 Jul;69(3):249-56. doi: 10.1016/j.maturitas.2011.04.011. Epub 2011 May 25.
citation: Distante F, Pagani V, Bonfigli A. Stabilized hyaluronic acid of non-animal origin for rejuvenating the skin of the upper arm. Dermatol Surg. 2009 Feb;35 Suppl 1:389-93; discussion 394. doi: 10.1111/j.1524-4725.2008.01051.x. No abstract available.
citation: Williams S, Tamburic S, Stensvik H, Weber M. Changes in skin physiology and clinical appearance after microdroplet placement of hyaluronic acid in aging hands. J Cosmet Dermatol. 2009 Sep;8(3):216-25. doi: 10.1111/j.1473-2165.2009.00447.x.
citation: Reuther T, Bayrhammer J, Kerscher M. Effects of a three-session skin rejuvenation treatment using stabilized hyaluronic acid-based gel of non-animal origin on skin elasticity: a pilot study. Arch Dermatol Res. 2010 Jan;302(1):37-45. doi: 10.1007/s00403-009-0988-9.
citation: Ribe A, Ribe N. Neck skin rejuvenation: histological and clinical changes after combined therapy with a fractional non-ablative laser and stabilized hyaluronic acid-based gel of non-animal origin. J Cosmet Laser Ther. 2011 Aug;13(4):154-61. doi: 10.3109/14764172.2011.594060. Epub 2011 Jun 23.
citation: Tezel A, Fredrickson GH. The science of hyaluronic acid dermal fillers. J Cosmet Laser Ther. 2008 Mar;10(1):35-42. doi: 10.1080/14764170701774901.
citation: Wang F, Garza LA, Kang S, Varani J, Orringer JS, Fisher GJ, Voorhees JJ. In vivo stimulation of de novo collagen production caused by cross-linked hyaluronic acid dermal filler injections in photodamaged human skin. Arch Dermatol. 2007 Feb;143(2):155-63. doi: 10.1001/archderm.143.2.155.
citation: Alam M, Han S, Pongprutthipan M, Disphanurat W, Kakar R, Nodzenski M, Pace N, Kim N, Yoo S, Veledar E, Poon E, West DP. Efficacy of a needling device for the treatment of acne scars: a randomized clinical trial. JAMA Dermatol. 2014 Aug;150(8):844-9. doi: 10.1001/jamadermatol.2013.8687.
citation: Kim SE, Lee JH, Kwon HB, Ahn BJ, Lee AY. Greater collagen deposition with the microneedle therapy system than with intense pulsed light. Dermatol Surg. 2011 Mar;37(3):336-41. doi: 10.1111/j.1524-4725.2011.01882.x. Epub 2011 Feb 22.
citation: Lim HK, Suh DH, Lee SJ, Shin MK. Rejuvenation effects of hyaluronic acid injection on nasojugal groove: prospective randomized split face clinical controlled study. J Cosmet Laser Ther. 2014 Jan;16(1):32-6. doi: 10.3109/14764172.2013.854620. Epub 2013 Nov 19.
citation: 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.
citation: Kassir R, Kolluru A, Kassir M. Extensive necrosis after injection of hyaluronic acid filler: case report and review of the literature. J Cosmet Dermatol. 2011 Sep;10(3):224-31. doi: 10.1111/j.1473-2165.2011.00562.x.
citation: 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.