To Evaluate the Efficacy and Safety of Injection With HARA as Compared to Restylane® Lidocaine in Temporary Correction of Nasolabial Folds
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
1 other identifier
interventional
67
1 country
1
Brief 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 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 23, 2019
CompletedFirst Submitted
Initial submission to the registry
September 5, 2019
CompletedFirst Posted
Study publicly available on registry
January 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2020
CompletedJanuary 13, 2020
January 1, 2020
9 months
September 5, 2019
January 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Week 24 From baseline Visit(=Investigational Device Injection)
Study Arms (2)
Test Device Group(HARA filler)
EXPERIMENTALComparator Group(Restylane® Lidocaine)
ACTIVE COMPARATORInterventions
The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).
The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huons Co., Ltd.lead
- Humedix Co., Ltd.collaborator
Study Sites (1)
Huons
Seongnam-si, South Korea
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2019
First Posted
January 13, 2020
Study Start
April 23, 2019
Primary Completion
January 30, 2020
Study Completion
July 30, 2020
Last Updated
January 13, 2020
Record last verified: 2020-01