Nasolabial FOLDNCT04224649
To Evaluate the Efficacy and Safety of Injection With HARA as Compared to Restylane® Lidocaine in Temporary Correction of Nasolabial Folds
A study testing HARA Filler(Hyaluronic acid Filler) and Restylane® Lidocaine in people with Nasolabial FOLD, run by Huons Co., Ltd. at 1 site in South Korea.
Trial summary
Investigational Device : HARA (Hyaluronic Acid Filler) Title : A Single center, Randomized, Subject \& Evaluator-blind, Matched pairs, Active-controlled design Pivotal study to Evaluate the Efficacy and Safety of Injection with HARA as Compared to Restylane® Lidocaine in temporary Correction of Nasolabial folds Sites… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasolabial FOLD
- What is being tested?
- HARA Filler(Hyaluronic acid Filler) and Restylane® Lidocaine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Apr 2019to 30 Jul 2020
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those who agreed to this treatment and signed the Informed Consent Form
- Those who are 19 years old or more and desire to take correction of nasolabial folds
- Those who have an intention of refraining from other cosmetic treatment(other filler injection, laser or chemical peeling, Botox injection or wrinkle reduction) during the clinical study period
- Those whose Wrinkle Severity Rating Scale (WSRS) is more than 2 points at least
Who cannot join
- Those who are sensitive to lidocaine or other amide anesthesia
- Those who are sensitive to control device
- Those who are pregnant or lactating, or expect pregnancy
- Those who are judged by the subinvestigator to be improper for this study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Huons
Seongnam-si
Choi Yubeen, 07074925965, ybin9398@huons.com
About this study
Official title: A Single Center, Randomized, Subject & Evaluator-blind, Matched Pairs, Active-controlled Design Pivotal Study to Evaluate the Efficacy and Safety of Injection With HARA as Compared to Restylane® Lidocaine in Temporary Correction of Nasolabial Folds
- Investigational Device : HARA (Hyaluronic Acid Filler)
- Title : A Single center, Randomized, Subject \& Evaluator-blind, Matched pairs, Active-controlled design Pivotal study to Evaluate the Efficacy and Safety of Injection with HARA as Compared to Restylane® Lidocaine in temporary Correction of Nasolabial folds
- Sites and investigators : Chung-ang University Hospital(Seoul), Beom-Joon Kim, M.D, Ph.D
- Objective : To compare the non-inferiority of HARA with Restylane® Lidocaine for evaluation of the efficacy and safety on Nasolabial Folds
- Conditions
- Nasolabial FOLD
- Being tested
- HARA Filler(Hyaluronic acid Filler), Restylane® Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HARA Filler(Hyaluronic acid Filler)Device
The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).
Restylane® LidocaineDevice
The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).
| Study group | Role | What they receive |
|---|---|---|
| Test Device Group(HARA filler) | Experimental | Not described Receives: Device: HARA Filler(Hyaluronic acid Filler) |
| Comparator Group(Restylane® Lidocaine) | Active comparator | Not described Receives: Device: Restylane® Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment By independent evaluator
Wrinkle Severity Rating Scale (WSRS, Wrinkle severity Rating scale)
- Grade 1: Absent, Grade 2: Mild, Grade 3: Moderate, Grade 4: Severe, Grade 5: Extereme
Measured: Week 24 From baseline Visit(=Investigational Device Injection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start23 Apr 2019
- Primary completion30 Jan 2020 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial FOLDStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huons Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Humedix Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224649
- Sponsor's protocol ID
- HU-055
- Status last verified
- Jan 2020
- First submitted
- 5 Sep 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Subject & Evaluator-blind, Matched Pairs, Active-controlled Design Pivotal Study to Evaluate the Efficacy and Safety of Injection With HARA as Compared to Restylane® Lidocaine in Temporary Correction of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT04224649
- Acronym / sponsor ID
- HU-055
- Conditions
- Nasolabial FOLD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Huons Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Humedix Co., Ltd.
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 30 Jan 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 13 Jan 2020 (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.
- Investigational Device : HARA (Hyaluronic Acid Filler)
- Title : A Single center, Randomized, Subject \& Evaluator-blind, Matched pairs, Active-controlled design Pivotal study to Evaluate the Efficacy and Safety of Injection with HARA as Compared to Restylane® Lidocaine in temporary Correction of Nasolabial folds
- Sites and investigators : Chung-ang University Hospital(Seoul), Beom-Joon Kim, M.D, Ph.D
- Objective : To compare the non-inferiority of HARA with Restylane® Lidocaine for evaluation of the efficacy and safety on Nasolabial Folds
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Device Group(HARA filler) | Experimental | Device: HARA Filler(Hyaluronic acid Filler) |
| Comparator Group(Restylane® Lidocaine) | Active comparator | Device: Restylane® Lidocaine |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Those who agreed to this treatment and signed the Informed Consent Form
- Those who are 19 years old or more and desire to take correction of nasolabial folds
- Those who have an intention of refraining from other cosmetic treatment(other filler injection, laser or chemical peeling, Botox injection or wrinkle reduction) during the clinical study period
- Those whose Wrinkle Severity Rating Scale (WSRS) is more than 2 points at least
Key exclusion criteria (4 listed)
- Those who are sensitive to lidocaine or other amide anesthesia
- Those who are sensitive to control device
- Those who are pregnant or lactating, or expect pregnancy
- Those who are judged by the subinvestigator to be improper for this study
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 |
|---|---|---|
| HARA Filler(Hyaluronic acid Filler)The same participants received the experimental device and the active comparator device at the same time (left and right sides of face). | Device | Test Device Group(HARA filler) |
| Restylane® LidocaineThe same participants received the experimental device and the active comparator device at the same time (left and right sides of face). | Device | Comparator Group(Restylane® Lidocaine) |
Primary outcome
Assessment By independent evaluator
Time frame: Week 24 From baseline Visit(=Investigational Device Injection)
Wrinkle Severity Rating Scale (WSRS, Wrinkle severity Rating scale) * Grade 1: Absent, Grade 2: Mild, Grade 3: Moderate, Grade 4: Severe, Grade 5: Extereme
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HARA Filler(Hyaluronic acid Filler) and Restylane® Lidocaine in people with Nasolabial FOLD, run by Huons Co., Ltd. at 1 site 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 4 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: status not confirmed, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment By independent evaluator (time frame: Week 24 From baseline Visit(=Investigational Device Injection)). 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 13 Jan 2020.