AgingPhase 4NCT02312154

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

A Phase 4 study testing Restylane Vital in people with Aging, run by Konkuk University Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 25 years and olderHealthy volunteers can take part
Conditions the study is for: Aging
What is being tested?: Restylane Vital
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: No sites listed yet
Study dates: Apr 2014to Dec 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy people older than 25 years

Who cannot join

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

About this study

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

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.

Read the 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.

Conditions: Aging
Being tested: Restylane Vital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02312154
Study group	Role	What they receive
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) Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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)
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2014Dec 2014

First posted9 Dec 2014 (estimated)
Study startApr 2014
Primary completionJul 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (17)Papers the sponsor has linked to this study.
Other trials for AgingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Investigator
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02312154
Sponsor's protocol ID: KUH1120048
Status last verified: Mar 2015
First submitted: 5 Dec 2014
Last updated: 3 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 9856828
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.
PubMed 16531934
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.
PubMed 18384619
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.
PubMed 24002145
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.
PubMed 21612880
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.
PubMed 19207331
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.
PubMed 19735521
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.
PubMed 19730872
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.
PubMed 21699363
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.
PubMed 18330796
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.
PubMed 17309996
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.
PubMed 24919799
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.
PubMed 21342311
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.
PubMed 24245880
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.
PubMed 19807757

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Split-face Study of Changing in Skin Physiology and Clinical Appearance After Microdroplet Placement of Stabilized Hyaluronic Acid in Aging Faces
ClinicalTrials.gov ID: NCT02312154
Acronym / sponsor ID: KUH1120048
Conditions: Aging
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Konkuk University HospitalUniversity, hospital or other
Study start: Apr 2014
Primary completion: Jul 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 9 Dec 2014 (estimated)
Results: Posted 24 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
treated side (Restylane vital)	Experimental	Device: Restylane VitalWe injected staabilized hyaluronic acid (HA)-based gel of nonanimal origin on the left side of face. (We performed split face study)
untreated side (control)	No intervention	–We did nothing on the right side of face and we compared the results on same participants

Who may qualify

Ages: 25 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Healthy people older than 25 years

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Restylane Vitalstabilized hyaluronic acid (HA)-based gel of nonanimal origin	Device	treated side (Restylane vital)

Primary outcome

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)
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)
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).
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)
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.
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

Results and safety

Results posted to the registry on 24 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Restylane Vital	25	24

Primary outcome: Hydration Level

Time frame: 12 weeks. Mean (Standard Deviation). Unit: AU (arbitrary unit)

Measure	Treated Side (Restylane Vital) n = 24	Untreated Side n = 24
Value	53.19 (9.08)	46.75 (9.24)

Treated Side (Restylane Vital) vs Untreated Side: p <0.05, Wilcoxon (Mann-Whitney)

Primary outcome: Elasticity

Time frame: 12 weeks. Mean (Standard Deviation). Unit: AU (arbitrary unit)

Measure	Treated Side (Restylane Vital) n = 24	Untreated Side n = 24
Value	242.33 (72.21)	271.15 (86.10)

Treated Side (Restylane Vital) vs Untreated Side: p <0.05, Wilcoxon (Mann-Whitney)

Primary outcome: Melanin Index

Time frame: 12 weeks. Mean (Standard Deviation). Unit: AU (arbitrary unit)

Measure	Treated Side (Restylane Vital) n = 24	Untreated Side n = 24
Value	147.25 (27.46)	149.00 (26.86)

Treated Side (Restylane Vital) vs Untreated Side: p <0.05, Wilcoxon (Mann-Whitney)

Primary outcome: Erythema Index

Time frame: 12 weeks. Mean (Standard Deviation). Unit: AU (arbitrary unit)

Measure	Treated Side (Restylane Vital) n = 24	Untreated Side n = 24
Value	253.66 (58.19)	243.53 (51.65)

Treated Side (Restylane Vital) vs Untreated Side: p <0.05, Wilcoxon (Mann-Whitney)

Adverse events

Time frame: 12weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Restylane Vital	0 of 24 (0%)	24 of 24 (100%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 9856828Gniadecka 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.
Background: PubMed 16531934Matarasso 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.
Background: PubMed 18384619Kerscher 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.
Background: PubMed 24002145Streker 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.
Background: PubMed 21612880Naylor 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.
Background: PubMed 19207331Distante 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.
Background: PubMed 19735521Williams 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.
Background: PubMed 19730872Reuther 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.
Background: PubMed 21699363Ribe 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.
Background: PubMed 18330796Tezel A, Fredrickson GH. The science of hyaluronic acid dermal fillers. J Cosmet Laser Ther. 2008 Mar;10(1):35-42. doi: 10.1080/14764170701774901.
Background: PubMed 17309996Wang 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.
Background: PubMed 24919799Alam 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yang Won Lee, MD, PhD principal investigator

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Restylane Vital in people with Aging, run by Konkuk University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hydration Level (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02312154, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2015.