NCT01940575

Brief Summary

\- Study design:Multi-center, randomized, double-masked (Unblinded treating investigators), intra-individual comparison clinical trial

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 8, 2014

Status Verified

April 1, 2014

Enrollment Period

6 months

First QC Date

September 8, 2013

Last Update Submit

April 6, 2014

Conditions

Wrinkle

Keywords

Tissue restorative biomaterialHyaluronic acidRestylane®Wrinkle Severity Rating Scale (WSRS)Global Aesthetic Improvement Scale (GAIS)Nasolabial fold(NLF)

Outcome Measures

Primary Outcomes (1)

  • The change in WSRS of the test group and control group

    The change in WSRS of the test group and control group from baseline at 24 weeks as assessed by the Investigator in charge of photographic assessment

    Baseline and 24 weeks

Secondary Outcomes (1)

  • The change in WSRS of the test and control groups

    baseline and 2, 8, 16, 24 weeks

Other Outcomes (1)

  • The percentage of subjects whose GAIS is 1 point or above

    2, 8,16, 24 weeks

Study Arms (2)

Restylane®

ACTIVE COMPARATOR

Inject Restylane® on right or left nasolabial fold

Device: Restylane®

SkinPlus-Hyal®

EXPERIMENTAL

Inject SkinPlus-Hyal® on right or left nasolabial fold

Device: SkinPlus-Hyal®

Interventions

SkinPlus-Hyal®DEVICE

The Injector will administer to the eligible subject the Study Device and Comparator Device (Comparator or Study Device) respectively to the left and right nasolabial fold in a randomized manner.

SkinPlus-Hyal®
Restylane®DEVICE

The Injector will administer to the eligible subject the Study Device and Comparator Device (Comparator or Study Device) respectively to the left and right nasolabial fold in a randomized manner.

Restylane®

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women aged over 20
  • Subjects who want to correct his/her nasolabial fold and have point 3 or 4 in WSRS of nasolabial fold and visually symmetric
  • Subjects who voluntarily decided the participation of the study and signed the informed consent
  • Subjects who agree contraception

You may not qualify if:

  • Subjects who had anaphylaxis or a severe combined allergy, or an allergy to hyaluronic acid
  • Subjects who had eczema, infection, psoriasis, sclerosis, acne on the face
  • Subjects who have a skin disorder on the NLF area
  • Subjects who had permanent implants for dermal augmentation at the NLF area
  • Subjects who had a history of keloid formation or hypertrophic scar
  • Subjects who participated in other clinical trial within 3 months from screening date
  • Female subjects of childbearing potential who disagreed with medically acceptable contraception (e.g., condom, oral contraceptives continuing at least 3 months, injectable or insertable contraceptives, intrauterine contraceptive devices) during the trial
  • Subjects who is Drug abuser or alcoholism
  • Subjects who had previous treatment with Botox within 6 months from screening date
  • Subjects who had previous treatment for wrinkle with Retin-A within 1 months from screening date
  • Subjects who had previous treatment with tissue restorative biomaterials within 18 months from screening date
  • Patients who are not eligible for this study at the medical discretion of the Principal Investigator or Sub-investigator
  • Subjects who had antigen of HIV or type-B Hepatitis
  • Subjects who had anti-coagulant therapy within 2 weeks from the screening date
  • Patients who are not eligible for this study at the medical discretion of the Principal Investigator or Sub-investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul national university Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Seoul National University Hospital

Jongno-gu, Seoul, 110-744, South Korea

Location

Study Officials

  • Chanyeong - Heo, Ph.D

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2013

First Posted

September 12, 2013

Study Start

July 1, 2013

Primary Completion

January 1, 2014

Study Completion

March 1, 2014

Last Updated

April 8, 2014

Record last verified: 2014-04

Locations

KR(2)