Clinical trial NCT01940575: Efficacy and Safety Study of SkinPlus-Hyal® to Nasolabial Fold
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkle
Keywords: Tissue restorative biomaterial
Hyaluronic acid
Restylane®
Wrinkle Severity Rating Scale (WSRS)
Global Aesthetic Improvement Scale (GAIS)
Nasolabial fold(NLF)
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: HumanTissueKorea Ltd.
First posted: 2013-09-12
Enrollment: 123
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: The change in WSRS of the test group and control group
timeFrame: Baseline and 24 weeks
Secondary outcomes:
measure: The change in WSRS of the test and control groups
timeFrame: baseline and 2, 8, 16, 24 weeks
Other outcomes:
measure: The percentage of subjects whose GAIS is 1 point or above
timeFrame: 2, 8,16, 24 weeks
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul national university Bundang Hospital
state: Gyeonggi-do
city: Jongno-gu
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Chanyeong - Heo, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: