WrinkleNCT01940575
Efficacy and Safety Study of SkinPlus-Hyal® to Nasolabial Fold
A study testing SkinPlus-Hyal® and Restylane® in people with Wrinkle, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
Study design:Multi-center, randomized, double-masked (Unblinded treating investigators), intra-individual comparison clinical trial Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wrinkle
- What is being tested?
- SkinPlus-Hyal® and Restylane®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jul 2013to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University Hospital
Jongno-gu, Seoul, 110-744
Seoul national university Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
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 design:Multi-center, randomized, double-masked (Unblinded treating investigators), intra-individual comparison clinical trial
Read the 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
- Being tested
- SkinPlus-Hyal®, Restylane®
- Keywords
- Tissue restorative biomaterial, Hyaluronic acid, Restylane®, Wrinkle Severity Rating Scale (WSRS), Global Aesthetic Improvement Scale (GAIS), Nasolabial fold(NLF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Restylane® | Active comparator | Inject Restylane® on right or left nasolabial fold Receives: Device: Restylane® |
| SkinPlus-Hyal® | Experimental | Inject SkinPlus-Hyal® on right or left nasolabial fold Receives: Device: SkinPlus-Hyal® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 24 weeks
Secondary outcomes (1)
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
Measured: baseline and 2, 8, 16, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startJul 2013
- Primary completionJan 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinkleStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- HumanTissueKorea Ltd.
- Responsible party
- Sponsor
- Investigators
- Chanyeong - Heo, Ph.D, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940575
- Sponsor's protocol ID
- E-1010-055-001
- Other IDs
- 06-2013-083
- Status last verified
- Apr 2014
- First submitted
- 8 Sep 2013
- Last updated
- 8 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01940575
- Acronym / sponsor ID
- E-1010-055-001
- Conditions
- Wrinkle
- Keywords
- Tissue restorative biomaterial, Hyaluronic acid, Restylane®, Wrinkle Severity Rating Scale (WSRS), Global Aesthetic Improvement Scale (GAIS), Nasolabial fold(NLF)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- HumanTissueKorea Ltd.
- Study start
- Jul 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 12 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restylane® | Active comparator | Device: Restylane®Inject Restylane® on right or left nasolabial fold |
| SkinPlus-Hyal® | Experimental | Device: SkinPlus-Hyal®Inject SkinPlus-Hyal® on right or left nasolabial fold |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | SkinPlus-Hyal® |
| 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. | Device | Restylane® |
Primary outcome
The change in WSRS of the test group and control group
Time frame: Baseline and 24 weeks
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
1 secondary outcome
The change in WSRS of the test and control groups
Time frame: baseline and 2, 8, 16, 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chanyeong - Heo, Ph.D principal investigator
Seoul National University Bundang Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SkinPlus-Hyal® and Restylane® in people with Wrinkle, run by Seoul National University Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in WSRS of the test group and control group (time frame: Baseline and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2014.