Wrinkle Severity Rating Scale(WSRS) Grade 3 (Moderate) or 4 (Severe) of Nasolabial FoldsPhase 3NCT03170050
Clinical Trial of YYD701-2 for Treatment of Nasolabial Folds
A Phase 3 study testing YYD701-2 and Restylane Perlane Lidocaine in people with Wrinkle Severity Rating Scale(WSRS) Grade 3 (Moderate) or 4 (Severe) of Nasolabial Folds, run by Yooyoung Pharmaceutical Co., Ltd. at 2 sites in South Korea.
Trial summary
A multicenter, active-controlled, randomized, evaluator and subject blinded, split-face, comparative, non-inferiority, Medical device Clinical trial. This study is randomized, evaluator and subject blinded, split-face medical device Clinical trial. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Wrinkle Severity Rating Scale(WSRS) Grade 3 (Moderate) or 4 (Severe) of Nasolabial Folds
- What is being tested?
- YYD701-2 and Restylane Perlane Lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 1 Mar 2017to 21 Nov 2017
- Phase
- Phase 3
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and Female aged between 30 and 75 years, inclusive
- Subjects who want improvement of nasolabial folds that are rated as grade 3 or 4 on Wrinkle severity rating scale(WSRS)
- Subjects who have visually symmetrical bilateral nasolabial folds
- Subjects who consent to discontinue all dermatological treatment or cure including wrinkle correction in and around infraorbital region during this trial
- Subjects who voluntarily decide to participate in this trial and provide written consent in the Informed Consent Form
Who cannot join
- Subject who have bleeding disorder in the past or present
- Other criteria as identified in the protocol
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Chung-Ang Univ. Medical Center
Seoul
Konkuk University Medical Center
Seoul
About this study
Official title: A Multicenter, Active-controlled, Randomized, Evaluator and Subject Blinded, Split-face, Comparative, Non-inferiority and Confirmatory Clinical Study of the Efficacy and Safety Between YYD701-2 and Restylane Perlane Lidocaine for Temporary Correction of Moderate to Severe Nasolabial Folds
A multicenter, active-controlled, randomized, evaluator and subject blinded, split-face, comparative, non-inferiority, Medical device Clinical trial.
This study is randomized, evaluator and subject blinded, split-face medical device Clinical trial. The Subjects are injected investigational device(YYD701-2 or Restylane Perlane Lidocaine) in right or left nasolabial folds.
- Being tested
- YYD701-2, Restylane Perlane Lidocaine
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YYD701-2Device
HA Filler
Restylane Perlane LidocaineDevice
HA Filler
| Study group | Role | What they receive |
|---|---|---|
| YYD701-2 | Experimental | YYD701-2 Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection Receives: Device: YYD701-2 |
| Restylane Perlane Lidocaine | Active comparator | Restylane Perlane Lidocaine Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection Receives: Device: Restylane Perlane Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by independent evaluator through Photographs.
Score of WSRS assessed by the independent evaluator
Measured: from baseline to 24 weeks
Secondary outcomes (7)
The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by independent evaluator through Photographs.
Score of WSRS assessed by the independent evaluator
Measured: from baseline to 2, 8, 16 weeks
The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by investigator.
Score of WSRS assessed by the investigator
Measured: from baseline to 2, 8, 16, 24 weeks
Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by an investigator
Score of GAIS assessed by the investigator
Measured: 2, 8, 16, 24 weeks after week 0 (injection date)
Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by a subject
Score of GAIS assessed by subject
Measured: 2, 8, 16, 24 weeks after week 0 (injection date)
Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by independent evaluator through Photographs.
Score of WSRS assessed by the independent evaluator
Measured: from baseline to 2, 8, 16, 24 weeks
Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by the investigator
Score of WSRS assessed by the investigator
Measured: from baseline to 2, 8, 16, 24 weeks
Visual Analogue Scale as evaluated by a subject
Score of VAS assessed by subject
Measured: week 0 (injection date)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start1 Mar 2017
- Primary completion21 Nov 2017
- Study completion21 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrinkle Severity Rating Scale(WSRS) Grade 3 (Moderate) or 4 (Severe) of Nasolabial FoldsStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- The Subjects are injected investigational devide(YYD701-2 or Restylane Perlane Lidocaine) in right or left nasolabial folds
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yooyoung Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170050
- Sponsor's protocol ID
- YYP-YYD701_001
- Status last verified
- Dec 2017
- First submitted
- 30 Mar 2017
- Last updated
- 10 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Active-controlled, Randomized, Evaluator and Subject Blinded, Split-face, Comparative, Non-inferiority and Confirmatory Clinical Study of the Efficacy and Safety Between YYD701-2 and Restylane Perlane Lidocaine for Temporary Correction of Moderate to Severe Nasolabial Folds
- ClinicalTrials.gov ID
- NCT03170050
- Acronym / sponsor ID
- YYP-YYD701_001
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Yooyoung Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 21 Nov 2017 (actual)
- Study completion
- 21 Nov 2017 (actual)
- First posted
- 30 May 2017 (actual)
- 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.
A multicenter, active-controlled, randomized, evaluator and subject blinded, split-face, comparative, non-inferiority, Medical device Clinical trial.
This study is randomized, evaluator and subject blinded, split-face medical device Clinical trial. The Subjects are injected investigational device(YYD701-2 or Restylane Perlane Lidocaine) in right or left nasolabial folds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The Subjects are injected investigational devide(YYD701-2 or Restylane Perlane Lidocaine) in right or left nasolabial folds
| Arm | Type | Receives |
|---|---|---|
| YYD701-2 | Experimental | Device: YYD701-2YYD701-2 Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection |
| Restylane Perlane Lidocaine | Active comparator | Device: Restylane Perlane LidocaineRestylane Perlane Lidocaine Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and Female aged between 30 and 75 years, inclusive
- Subjects who want improvement of nasolabial folds that are rated as grade 3 or 4 on Wrinkle severity rating scale(WSRS)
- Subjects who have visually symmetrical bilateral nasolabial folds
- Subjects who consent to discontinue all dermatological treatment or cure including wrinkle correction in and around infraorbital region during this trial
- Subjects who voluntarily decide to participate in this trial and provide written consent in the Informed Consent Form
Key exclusion criteria (2 listed)
- Subject who have bleeding disorder in the past or present
- Other criteria as identified in the protocol
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 |
|---|---|---|
| YYD701-2HA Filler | Device | YYD701-2 |
| Restylane Perlane LidocaineHA Filler | Device | Restylane Perlane Lidocaine |
Primary outcome
The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by independent evaluator through Photographs.
Time frame: from baseline to 24 weeks
Score of WSRS assessed by the independent evaluator
7 secondary outcomes
The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by independent evaluator through Photographs.
Time frame: from baseline to 2, 8, 16 weeks
The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by investigator.
Time frame: from baseline to 2, 8, 16, 24 weeks
Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by an investigator
Time frame: 2, 8, 16, 24 weeks after week 0 (injection date)
Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by a subject
Time frame: 2, 8, 16, 24 weeks after week 0 (injection date)
Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by independent evaluator through Photographs.
Time frame: from baseline to 2, 8, 16, 24 weeks
Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by the investigator
Time frame: from baseline to 2, 8, 16, 24 weeks
Visual Analogue Scale as evaluated by a subject
Time frame: week 0 (injection date)
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 10 May 2021.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing YYD701-2 and Restylane Perlane Lidocaine in people with Wrinkle Severity Rating Scale(WSRS) Grade 3 (Moderate) or 4 (Severe) of Nasolabial Folds, run by Yooyoung Pharmaceutical Co., Ltd. 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 5 inclusion and 2 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 10 May 2021. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Wrinkle Severity Rating Scale (WSRS) as evaluated by independent evaluator through Photographs. (time frame: from baseline to 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 10 May 2021.