Correction of Nasolabial Folds
Conditions
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
Interventions
DEVICEDermalax 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.
DEVICERestylane 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.
Sponsors
Across Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safty evaluation | for 24weeks | adverse events, laboratory test, physical examination |
Countries
South Korea
Outcome results
None listed