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

Across Co., Ltd.

Status and phase: Completed; Phase 3

Conditions: Correction of Nasolabial Folds

Treatments: Device: Dermalax Implant Plus; Device: Restylane Sub-Q

Study type: Interventional

Funder types: Industry

Identifiers

NCT02179606

AC-13-01

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Dermalax Implant Plus

Experimental group

Description:

Subject injected in the nasolabial folds of one side of the face in the initial treatment period.

Treatment:

Device: Dermalax Implant Plus

Device: Restylane Sub-Q

Restylane Sub-Q

Active Comparator group

Description:

Subject injected in the nasolabial folds of one side of the face in the initial treatment period.

Treatment:

Device: Dermalax Implant Plus

Device: Restylane Sub-Q