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Completed

NCT Number: NCT02179606

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

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

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Key information

Conditions

Correction of Nasolabial Folds

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chung-ang University Hospital, Seoul, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: baseline, week 12

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

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 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

  3. 100 mm visual analogue scale (VAS) scores evaluation

    Time frame: week 0

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

Other outcomes

  1. Safty evaluation

    Time frame: for 24weeks

    adverse events, laboratory test, physical examination

Sponsors and collaborators

Lead sponsor

Across Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
First posted
Jul 2, 2014
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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