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

NCT02179606 | Completed Phase 3

• 1 other identifier: AC-13-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Conditions

Correction of Nasolabial Folds

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  baseline, at week 2~24

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

  at week 2~24

• 100 mm visual analogue scale (VAS) scores evaluation

  week 0

Other Outcomes (1)

• Safty evaluation

  for 24weeks

Study Arms (2)

Dermalax Implant Plus

EXPERIMENTAL

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

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

Restylane Sub-Q

ACTIVE COMPARATOR

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

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

Interventions

Dermalax Implant Plus DEVICE

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.

Dermalax Implant Plus; Restylane Sub-Q

Restylane Sub-Q DEVICE

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.

Dermalax Implant Plus; Restylane Sub-Q

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects no younger than 30 and no more than 75 years of age.
• 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.
• Subjects who have symmetric nasolabial folds.

You may not qualify if:

• Subjects who received an antithrombotic agent within 2 weeks prior to screening (with the exception of low dose Aspirin less than 300 mg/day)
• Subjects who have a history of bleeding disorder.
• Subjects who have received calcium hydroxyapatite, CaHA injection in nasolabial area.

Sponsors & Collaborators

• Across Co., Ltd.: lead

Study Sites (2)

Chung-ang University Hospital

Seoul, South Korea

Location

Eulji General Hospital

Seoul, South Korea

Location

Study Officials

• Beom Joon Kim, MD

  Chung-Ang University Hosptial, Chung-Ang University College of Medicine

  PRINCIPAL INVESTIGATOR

• Jong Hoon Lee, MD

  Eulji General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2014
• First Posted: July 2, 2014
• Study Start: July 1, 2013
• Primary Completion: March 1, 2014
• Last Updated: July 8, 2014

Record last verified: 2014-03

Locations

KR (2)