To Evaluate the Efficacy and Safety of Injection With HARA as Compared to Restylane® Lidocaine in Temporary Correction of Nasolabial Folds
NCT ID: NCT04224649
Last Updated: 2020-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
67 participants
INTERVENTIONAL
2019-04-23
2020-07-30
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Test Device Group(HARA filler)
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).
Comparator Group(Restylane® Lidocaine)
Restylane® Lidocaine
The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).
Interventions
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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).
Restylane® Lidocaine
The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).
Eligibility Criteria
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Inclusion Criteria
2. Those who are 19 years old or more and desire to take correction of nasolabial folds
3. 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
4. Those whose Wrinkle Severity Rating Scale (WSRS) is more than 2 points at least
Exclusion Criteria
2. Those who are sensitive to control device
3. Those who are pregnant or lactating, or expect pregnancy
4. Those who are judged by the subinvestigator to be improper for this study
19 Years
ALL
Yes
Sponsors
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Humedix Co., Ltd.
INDUSTRY
Huons Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Huons
Seongnam-si, , South Korea
Countries
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Facility Contacts
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Other Identifiers
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HU-055
Identifier Type: -
Identifier Source: org_study_id
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