None listed
Conditions
Interventions
Medical Device : Experimental Medical Device: PRM-001
Less than 1.0 ml in each eye, administered 4 times in 2 weeks intervals
Active Comparator Medical Device: YVOIRE Hydro
Less than 1.0 ml in each e
Sponsors
Gangwon Institute for Regional Program Evaluation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Wrinkle Severity is over 2 points Visual symmetry of eye wrinkle on both sides During the clinical trials, use of anti-wrinkle cream and dermatologic procedure is discontinued
Exclusion criteria
Exclusion criteria: Those who have a history of anaphylaxis or multiple severe allergies. Those who have treated by antithrombotic or non-steroid medication within the past 2 weeks to screening Those who have has used prescribed facial cream within 4 weeks before screening or who plan to continue using it during clinical trials Those who have taken soft tissue augmentation, laser or cosmetic facial surgery to improve the injection area in 6 months before participation in the clinical study Those who have treated by anti-wrinkle using CaHA within 1 year before screening Those who have received silicone or any other permanent filler in the the face Those who have untreated scar over 1 year which need treatment and who have scar or mark on application site Those who have scars or keloids Those who have skin disease or wound infection on the face Those who have abnormal liver function or abnormal blood coagulation or people who have to take antithrombotic medication during clinical trial period Those who have suffered from mental illness, or with cardiovascular, digestive, respiratory, endocrine, immune or nervous system disorders that can have a significant impact upon the clinical trial Those who suffer from alcohol abuse or drug abuse Those who is a smoker over 20 cigarettes a day Those whc have received any investigational product within 30 days prior to study enrollment during the course of this study. Be female and of child bearing potential and is pregnant or not using acceptable method of birth control. Those who are not acceptable to participate in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement rate(LCL seversity scale) by independent evaluator | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement rate(LCL seversity scale) by independent evaluator;Variation of Wrinkle severity(LCL seversity scale) by independent evaluator;Average score of Wrinkle severity(LCL seversity scale) by independent evaluator;Average score of self-assessment(Visual Analogue Scale) by subject | — |
Countries
Korea, Republic of
Contacts
Public ContactChang Sik Park
Seoul National University Bundang Hospital
Outcome results
None listed