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

Phase 3

Completed

• Conditions: Correction of Nasolabial Folds
• Interventions: Device: Dermalax Implant Plus; Device: Restylane Sub-Q

• Registration Number: NCT02179606
• Lead Sponsor: Across Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Status Verified: 2014-03
• Primary Completion: 2014-03
• Study First Submitted: 2014-06-30
• Study First Submitted QC: 2014-06-30
• Study First Posted: 2014-07-02
• Last Update Submitted: 2014-07-04
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dermalax Implant Plus	Dermalax Implant Plus	Subject injected in the nasolabial folds of one side of the face in the initial treatment period.
Dermalax Implant Plus	Restylane Sub-Q	Subject injected in the nasolabial folds of one side of the face in the initial treatment period.
Restylane Sub-Q	Dermalax Implant Plus	Subject injected in the nasolabial folds of one side of the face in the initial treatment period.
Restylane Sub-Q	Restylane Sub-Q	Subject injected in the nasolabial folds of one side of the face in the initial treatment period.

Primary Outcome Measures

Name	Time	Method
Improvement of wrinkle severity system scale(WSRS) scores of both Dermalax implant plus and Restylane® Sub-Q Group	baseline, week 12	Improvement of wrinkle severity system scale(WSRS) scores at week 12 compared to baseline by independent evaluator using photos.

Secondary Outcome Measures

Name	Time	Method
Improvement of wrinkle severity system scale(WSRS) scores of both Dermalax implant plus and Restylane® Sub-Q Group	baseline, at week 2~24	Improvement of wrinkle severity system scale(WSRS) scores at week2, week8, week 16, week 24 compared to baseline by independent evaluator using photos.
Proportion of subjects whose Global Aesthetic improvement Scale (GAIS) scores improved	at week 2~24	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
100 mm visual analogue scale (VAS) scores evaluation	week 0	100 mm visual analogue scale (VAS) scores at both nasolabial folds evaluated by subjects at application of the devices

Trial Locations

Locations (2)

Chung-ang University Hospital; 🇰🇷 Seoul, Korea, Republic of

Eulji General Hospital; 🇰🇷 Seoul, Korea, Republic of