Nasolabial Fold Correction
Conditions
Brief summary
Intend to prove the non-inferiority of Rejeunesse against the comparing medical device of Restylane Perlane in terms of improvement, efficacy, and safety of nasolabial fold on the face
Interventions
DEVICERejeunesse
The clinical medical device, Rejeunesse, is a cross-lined HA hydrogel made by using the cross-linker of 1, 4-butandiol diglycidyl ether (BDDE) with low toxicity from sodium hyaluronate derived from microorganisms. It is a tissue repair biological material in a gel type injected to the skin (thick skin - epidermis and surface of thick skin) near wrinkles on the face for the temporary improvement of wrinkles.
DEVICERestylane Perlane
Restylane Perlane selected as the control group is non-animal stabilized hyaluronic acid (NASHA) originating from bacterial fermentation. It is a tissue repair biomaterial for soft skin \[3\]. Restylane Perlane is widely used for wrinkle treatment, indented areas and other beauty purposes. Products used in this clinical study can be applied to all types of wrinkles on the face. Stabilized HA constituting the Restylane Perlane is slowly absorbed in the body after combining with water molecules in the skin tissue and is completely absorbed in the skin as a biodegradable substance. Therefore, no residue is left in the body.
Sponsors
Forest Hills Lab
New Medic Corporation
Sumin D&C
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Men and women aged more than 30 but less than 60; 2. Those with score 3 or 4 in the wrinkle severity rating scale (WSRS) among those who want the improvement of nasolabial folds; 3. Those with visually symmetrical with nasolabial folds; 4. Those who agree with the suspension of all the dermatological treatment including the improvement of wrinkle on the face during the clinical study; 5. Those who are able to read and follow instructions and participate during the entire period of clinical study; 6. Those who decide to participate in the clinical study on their wills and agree with the subject-agreement written form.
Exclusion criteria
1. Those with skin sensitiveness on the clinical medical devices according to the result of intradermal test in the screening period; 2. Those who were administered with the antithrombotic (I00mg, up to 300mg/day) or anti-steroid anti-inflammatory within 2 days from the screening; 3. Those taking the antithrombotic (low-capacity aspirin (100mg, up to 300mg/day) excluded) during the clinical study or abnormal blood coagulation or liver function; 4. Those who have used or are scheduled to use the part ointment on the facial surface within 4 weeks from the screening date (steroid, retinoid: only for the medicines and not the cosmetics); 5. Those treated for the improvement of wrinkle or pimp within 6 months from the screening date; 6. Those treated for improvement of wrinkle by using collagen or hyaluronic acid filler within 6 months from the screening date or decortication, skin regeneration treatment, or plastic surgery on the facial surface (including botox wrinkle treatment); 7. Those treated with application of clinical medical devices for CaHA (Calcium Hydroxy Apatite) within a year from the screening date; 8. Those inserted with permanent skin extending implant such as soft form or silicon on the facial surface 9. Those in need of treatment on facial surface but with scar not treated for more than a year or with scar on the areas applied with clinical medical devices; 10. Those with the history of anaphylaxis or sever complex allergy symptoms; 11. Those with history of hypertropic scar or keloid medical history; 12. Those with side effect on the EMLA cream in the past (NIA for the criteria of exclusion for subjects who are not to use the EMLA cream); 13. Those with skin problem or infection from cut influencing on this clinical study; 14. Those with degraded immune function; 15. Those with clinically serious problem on cardiovascular system, digestive system, respiratory system, endocrine system, and central nervous system or mental disease that significantly influences on this clinical study; 16. Those participating in other clinical studies within 30 days from the screening date; 17. Those who did not agree to participate in the contraception in the medically allowed methods among female subjects who are able to be pregnant during the clinical study; \* Medically allowed contraception method: Condom, oral contraception for more than 6 months, cases of using shot or inserting anti-conceptive or installing conceptive device in the womb; 18. Pregnant women or lactating women; 19. Other than aforementioned subjects, those with clinical opinion regarding them as inappropriate subjects in this study from the medical judgment from charging person or manager of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint Variables | 24th week after the final application of medical devices for clinical study and assess WSRS. | Verify the average value of the difference between Wrinkle Severity Rating Scale (WSRS) between control group and experiment group assessed by the independent evaluator on the 24th week after the final application of medical devices for clinical study Compare the average value of WSRS between control group and experiment group assessed by the independent evaluator on the 24th week after the final application of clinical medical devices. The WSRS is a 5 point scale with 1 being no wrinkles and 5 being extreme wrinkles. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average value of Visual Analogue Scale (VAS) between the experiment group and control group within 60 minutes after the final application of clinical medical devices. | 60 minutes after the final application of clinical medical devices | Make sure to evaluate the degree of pain on a scale from 0 to 10 that subjects feel in the operation when applying or immediately after applying the clinical medical devices. The Visual Analogue Scale (VAS) is the record of the severest pain on the one side while recording that there is no pain on the other side in the 10cm length of line. 0 is "no pain" and 10 is worst pain possible. |
| Average value of Wrinkle Severity Rating Scale (WSRS) between the experiment group and control group on the 8th week after the final application of clinical medical devices. | 8th week after the final application of clinical medical devices | Compare the Wrinkle Severity Rating Scale (WSRS) average value between experiment group and control group assessed by the independent evaluator on the 8th week after the final application of clinical medical devices. The WSRS is a 5 point scale with 1 being no wrinkles and 5 being extreme wrinkles. |
| Average value of global aesthetic improvement scale (GAIS) between control and experiment group assessed by the investigators on the 8th and 24th week after the final application of medical devices before the initial application of medical devices | 8th and 24th week after the final application of medical devices before the initial application of medical devices. | Compare the average value of GAIS assessed by each investigator on the 8th and 24th week after the final application compared to before the initial application of clinical medical devices |
| Average value of Global Aesthetic Improvement Scale (GAIS) between control group and experiment group assessed by the investigators on the 8th and 24th week after the final application of medical devices before the initial application of medical devices | 8th and 24th week after the final application compared to before the initial application of clinical medical devices | Compare the average value of Global Aesthetic Improvement Scale (GAIS) assessed by each investigator on the 8th and 24th week after the final application compared to before the initial application of clinical medical devices. The Global Aesthetic Improvement Scale is a 5 point scale that goes from -1: worse, 0: no change, 1: improved, 2: much improved and 3: very much improved. |
| Proportion of changes in wrinkle severity rating scale (WSRS) between control group and experiment group on the 24th week after the final application of medical devices compared to before the initial application of medical devices | 24th week after the final application compared to before the initial application of clinical medical devices. | Compare the control group and experiment group in terms of proportion of WSRS changes assessed by the independent evaluator on the 24th week after the final application compared to before the initial application of clinical medical devices. |
| Proportion of changes in wrinkle severity rating scale (WSRS) in the experiment group and control group on the 24'h week after the final application of medical devices prior to the initial application of medical devices assessed by the investigator. | 24th week after the application in comparison to before the initial application of clinical medical devices | Compare the control group and experiment group on the changes in WSRS value assessed by the investigator on the 24th week after the application in comparison to before the initial application of clinical medical devices |
Outcome results
None listed