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

NCT ID: NCT01940575

Last Updated: 2014-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-03-31

Brief Summary

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

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

Conditions

Wrinkle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Restylane®

Inject Restylane® on right or left nasolabial fold

Group Type: ACTIVE_COMPARATOR

Restylane®

Intervention Type: 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®

Inject SkinPlus-Hyal® on right or left nasolabial fold

Group Type: EXPERIMENTAL

SkinPlus-Hyal®

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HumanTissueKorea Ltd.

UNKNOWN

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chanyeong - Heo, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Seoul national university Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Seoul National University Hospital

Jongno-gu, Seoul, South Korea

Countries

South Korea

Other Identifiers

06-2013-083

Identifier Type: OTHER

Identifier Source: secondary_id

E-1010-055-001

Identifier Type: -

Identifier Source: org_study_id