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Status unknownNCT04224649Updated Jan 13, 2020

To Evaluate the Efficacy and Safety of Injection With HARA as Compared to Restylane® Lidocaine in Temporary Correction of Nasolabial Folds

An interventional study of HARA Filler(Hyaluronic acid Filler) and Restylane® Lidocaine in Nasolabial FOLD, sponsored by Huons Co., Ltd.. Status unknown at 1 site in South Korea. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-13.

Sponsored by Huons Co., Ltd. (part of Huons Global) · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Apr 2019, registered Sep 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • Nasolabial FOLD
03

In context

Lead sponsor

Huons Co., Ltd. is the lead sponsor of 29 studies on the registry; 5 are open to participants now.

Browse Huons Co., Ltd. studies →All Huons Global studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Those who agreed to this treatment and signed the Informed Consent Form
  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

Exclusion Criteria:

  1. Those who are sensitive to lidocaine or other amide anesthesia
  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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
67 participants (estimated)

Study arms

  • Experimental
    Test Device Group(HARA filler)

    Device: HARA Filler(Hyaluronic acid Filler)

  • Active comparator
    Comparator Group(Restylane® Lidocaine)

    Device: Restylane® Lidocaine

Interventions

  • DeviceHARA 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).

  • DeviceRestylane® Lidocaine

    The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).

06

What researchers measure

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

    Time frame: Week 24 From baseline Visit(=Investigational Device Injection)

07

Study locations

1 of 1 sites recruiting
  • Huons
    Seongnam-si, South Korea
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04224649
Lead sponsor
Huons Co., Ltd.
Collaborators
Humedix Co., Ltd.
Responsible party
Sponsor
First posted
Jan 13, 2020
Start date
Apr 23, 2019
Primary completion
Jan 30, 2020 (estimated)
Completion
Jul 30, 2020 (estimated)
Last update
Jan 13, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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