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

Nasolabial FOLD Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04224649
• Other study ID #: HU-055
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Nasolabial FOLD

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)