Efficacy and Safety Study of SkinPlus-Hyal® to Nasolabial Fold

Clinical Trial to Evaluate the Safety and Efficacy of SkinPlus-Hyal® as Tissue Restorative Biomaterials in the Improvement of Bilateral Nasolabial Fold Wrinkles

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

Study Overview

• Status: Completed
• Conditions: Wrinkle
• Intervention / Treatment: Device: Restylane®; Device: SkinPlus-Hyal®

Detailed Description

• Subjects:Adults with nasolabial fold
• Investigational Devices:

Study Device: SkinPlus-Hyal® Comparator Device: Restylane®

- Procedure Before Treatment: The subject's eligibility (inclusion/exclusion criteria) will be assessed, and the WSRS of his/her nasolabial fold wil be evaluated by the Investigator Treatment: The Injector will administer to the eligible subject the Study Device and Comparator Device respectively to the left and right nasolabial fold in a randomized manner. Post-Treatment: All subjects will visit the hospital at 2, 8, 16, 24 weeks since the day of administration, and will take pictures of the Nasolabial fold area and undergo efficacy and safety evaluation during each visit. The Photographic evaluator will evaluate the efficacy

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital
  • Seoul
    • Jongno-gu, Seoul, Korea, Republic of, 110-744
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Subjects who had anaphylaxis or a severe combined allergy, or an allergy to hyaluronic acid
2. Subjects who had eczema, infection, psoriasis, sclerosis, acne on the face
3. Subjects who have a skin disorder on the NLF area
4. Subjects who had permanent implants for dermal augmentation at the NLF area
5. Subjects who had a history of keloid formation or hypertrophic scar
6. Subjects who participated in other clinical trial within 3 months from screening date
7. 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
8. Subjects who is Drug abuser or alcoholism
9. Subjects who had previous treatment with Botox within 6 months from screening date
10. Subjects who had previous treatment for wrinkle with Retin-A within 1 months from screening date
11. Subjects who had previous treatment with tissue restorative biomaterials within 18 months from screening date
12. Patients who are not eligible for this study at the medical discretion of the Principal Investigator or Sub-investigator
13. Subjects who had antigen of HIV or type-B Hepatitis
14. Subjects who had anti-coagulant therapy within 2 weeks from the screening date
15. Patients who are not eligible for this study at the medical discretion of the Principal Investigator or Sub-investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Restylane®; Inject Restylane® on right or left nasolabial fold	Device: Restylane®; 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.
Experimental: SkinPlus-Hyal®; Inject SkinPlus-Hyal® on right or left nasolabial fold	Device: SkinPlus-Hyal®; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in WSRS of the test and control groups	The change in WSRS of the test and control groups from baseline at 2, 8, 16, 24 weeks as assessed by the Investigator	baseline and 2, 8, 16, 24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of subjects whose GAIS is 1 point or above	The percentage of subjects whose GAIS is 1 point or above at 2, 8, 16, 24 weeks after injection as assessed by the Investigator	2, 8,16, 24 weeks

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: HumanTissueKorea Ltd.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: September 8, 2013
• First Submitted That Met QC Criteria: September 8, 2013
• First Posted (Estimate): September 12, 2013

Study Record Updates

• Last Update Posted (Estimate): April 8, 2014
• Last Update Submitted That Met QC Criteria: April 6, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Hyaluronic acid; Tissue restorative biomaterial; Restylane®; Wrinkle Severity Rating Scale (WSRS); Global Aesthetic Improvement Scale (GAIS); Nasolabial fold(NLF)
• Other Study ID Numbers: E-1010-055-001; 06-2013-083 (Other Identifier: Seoul National University Bundang Hospital)