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

Wrinkle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01940575
• Other study ID #: E-1010-055-001
• Secondary ID: 06-2013-083
• Status: Completed
• Phase: N/A
• First received: September 8, 2013
• Last updated: April 6, 2014
• Start date: July 2013
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wrinkle

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Jongno-gu	Seoul
Korea, Republic of	Seoul national university Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	HumanTissueKorea Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No