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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04224649
Other study ID # HU-055
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 23, 2019
Est. completion date July 30, 2020

Study information

Verified date January 2020
Source Huons Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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


Recruitment information / eligibility

Status Recruiting
Enrollment 67
Est. completion date July 30, 2020
Est. primary completion date January 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility 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:

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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).

Locations

Country Name City State
Korea, Republic of Huons Seongnam-si

Sponsors (2)

Lead Sponsor Collaborator
Huons Co., Ltd. Humedix Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
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