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

A Multi-Center, Randomized, Subject and Evaluator Blind, Split-Face Comparative Medical Device Clinical Study to Evaluate the Efficacy and Safety of Dermalax Implant Plus to Restylane® Sub-Q for Correction of Nasolabial Folds

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 Overview

• Status: Completed
• Conditions: Correction of Nasolabial Folds
• Intervention / Treatment: Device: Dermalax Implant Plus; Device: Restylane Sub-Q

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Eulji General Hospital
  • Seoul, Korea, Republic of
    • Chung-Ang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dermalax Implant Plus; Subject injected in the nasolabial folds of one side of the face in the initial treatment period.	Device: Dermalax Implant Plus; 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.; Device: Restylane Sub-Q; 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.
Active Comparator: Restylane Sub-Q; Subject injected in the nasolabial folds of one side of the face in the initial treatment period.	Device: Dermalax Implant Plus; 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.; Device: Restylane Sub-Q; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	week 0

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safty evaluation	adverse events, laboratory test, physical examination	for 24weeks

Collaborators and Investigators

• Sponsor: Across Co., Ltd.
• Investigators: Principal Investigator: Beom Joon Kim, MD, Chung-Ang University Hosptial, Chung-Ang University College of Medicine; Principal Investigator: Jong Hoon Lee, MD, Eulji General Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: June 30, 2014
• First Submitted That Met QC Criteria: June 30, 2014
• First Posted (Estimate): July 2, 2014

Study Record Updates

• Last Update Posted (Estimate): July 8, 2014
• Last Update Submitted That Met QC Criteria: July 4, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: AC-13-01