Clinical Study to Evaluate the Efficacy and Safety of Dermalax Implant Plus

Across Co., Ltd.60 enrolled

Overview

This study is to verify that Dermalax Implant Plus is not inferior to the reference device, Restylane® Sub-Q, in terms of efficacy and safety in the correction of nasolabial folds

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Correction of Nasolabial Folds

Interventions

Dermalax Implant PlusDEVICE

Dermalax implant plus injection into one nasolabial fold(NFL) of one side of the face(blinded, split-face study design) in the initial treatment period.

Restylane Sub-QDEVICE

Restylane Sub-Q injection into one nasolabial fold(NFL) of one side of the face(blinded, split-face study design) in the initial treatment period.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female subjects no younger than 30 and no more than 75 years of age. 2. Subjects who scored 3 or 4 on the Wrinkle Severity Rating Scale (WSRS) and want to improve the appearance of their nasolabial folds (the subject does not need to have the same score on both sides.\*) \*The scores need not to be same on both sides, but the two nasolabial folds should have symmetry in the range of 3-4. 3. Subjects who have symmetric nasolabial folds. Exclusion Criteria: 1. Subjects who received an antithrombotic agent within 2 weeks prior to screening (with the exception of low dose Aspirin less than 300 mg/day) 2. Subjects who have a history of bleeding disorder. 3. Subjects who have received calcium hydroxyapatite, CaHA injection in nasolabial area.

Locations (2)

Chung-ang University Hospital

Seoul, South Korea

Eulji General Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Improvement of wrinkle severity system scale(WSRS) scores of both Dermalax implant plus and Restylane® Sub-Q Group

Improvement of wrinkle severity system scale(WSRS) scores at week 12 compared to baseline by independent evaluator using photos.

Time frame: baseline, week 12

Secondary Outcomes

Improvement of wrinkle severity system scale(WSRS) scores of both Dermalax implant plus and Restylane® Sub-Q Group

Improvement of wrinkle severity system scale(WSRS) scores at week2, week8, week 16, week 24 compared to baseline by independent evaluator using photos.

Time frame: baseline, at week 2~24

Proportion of subjects whose Global Aesthetic improvement Scale (GAIS) scores improved

Proportion of subjects whose Global Aesthetic improvement Scale (GAIS) scores improved at week2, week 8, week 12, week 16, week 24 evaluated by investigator at site

Time frame: at week 2~24

100 mm visual analogue scale (VAS) scores evaluation

100 mm visual analogue scale (VAS) scores at both nasolabial folds evaluated by subjects at application of the devices

Time frame: week 0

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.