Nasolabial Fold, Hypoplastic
Conditions
Brief summary
Auralya® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation. To evaluate the overall safety of the medical device and performance of Auralya® dermal filler in terms of absolute change of WSRS score (Wrinkle Severity Rating Scale) assessed by Investigator at 8 and 12 weeks after the initiation of treatment, compared to Baseline Visit (day 0).
Detailed description
Minimally invasive procedures (injectable dermal fillers) are among the techniques preferred by an increasing number of specialists in Aesthetics due to their clinical performance regarding volume restoration, and favourable safety profile. During January - March 2018, it was performed a review of the scientific literature to find similar investigations to determine the minimal clinical significant difference between Baseline and a period of 30 days after the end the treatment. In a similar dermal filler study, Takanobu Mashiko et al used a 5-grade WSRS and showed that, at 4 weeks after treatment, they achieved a 1.7 ± 0.5 (mean ± SD) improvement between those visits. Considering the exploratory nature of this study and the fact that this investigation is first in-human, we choose to take a 0.5 WSRS decrease, at 90 days from the treatment start, as a minimal clinically significant difference. The standard deviation considered for the sample size calculation was set at 0.8 WSRS points. By using a one-sided Wilcoxon Signed-rank test (matched pairs), a significance level of 0.05 and a power of 0.95 (probability of finding an effect when there is one), we calculated a total sample size of 31 subjects.
Interventions
DEVICEAuralya
Hyaluronic Acid-Dermal Filler
Sponsors
Opera CRO, a TIGERMED Group Company
I.R.A. Istituto Ricerche Applicate S.p.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
This trial is open label, multi-center, non-randomized single group.
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Men or women with age \> 35 and ≤ 65 years. 2. Subjects with nasolabial wrinkles, seeking tissue augmentation treatment and willing to receive HA Filler; 3. Subjects presenting a score of 2 (shallow wrinkles) or 3 (moderate, deep wrinkles) on the Wrinkles Severity Ranking Scale (WSRS); 4. Subjects who agree to discontinue all dermatological treatment and procedures during the study; 5. Subjects willing to provide signed informed consent to clinical investigation participation. 6. Able to communicate adequately with the Investigator and to comply with the requirements for the entire study.
Exclusion criteria
1. Subjects who have bleeding disorder in the past or present. 2. Use of aspirin and antiplatelet agents a week prior to treatment 3. Prior or planned use of topical injection to the face (steroid, retinoid: applicable only to drugs, not applicable to cosmetics), within 4 weeks prior to screening or during this study (steroid ointment for therapeutic objectives is allowed for short -term use of ≤14 consecutive days.). 4. Use of immunosuppressive, chemotherapies, or systemic corticosteroids within 12 weeks from screening. 5. History of anaphylaxis or severe complicated allergy symptoms. 6. Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders or previous mental disorders that may significantly affect the study. 7. Hypersensitivity skin reaction to the investigational device based on intradermal test results at screening. 8. Evidence or history of autoimmune disease or compromised immune system. 9. Treatment with anticoagulants, thrombolytics, or platelet inhibitors within 1 week prior to study participation; 10. Prior permanent fillers or fat graft procedures around nasolabial folds. 11. Wrinkle correction procedures (e.g., botulinum toxin A injection, face lift, soft tissue augmentation, medium-depth peel, dermal photorejuvenation, etc.) within 6 months prior to study participation. 12. History of hypersensitivity to local anesthetic of amide type or HA. 13. History of keloid formation or hypertrophic scar on the face. 14. Evidence of active infection on the face. 15. Wound, scar, or skin disorder or infection around nasolabial folds that may affect the efficacy assessment. 16. Pregnant woman, lactating woman, and man or woman of childbearing potential who is planning a pregnancy or is unwilling to use appropriate methods of contraception\* during the study, \*Methods of contraception: hormonal contraceptive, intrauterine device or intrauterine system, double barrier method (condom with spermicide/diaphragm or cervical cap with spermicide), surgical sterilization (vasectomy, tubal ligation, etc.). 17. As with all dermal filler procedures, the product should not be used in vascular rich areas. 18. Subjects with illness, or other medical condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the study. 19. Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate safety and performance of Auralya | 12 weeks | To evaluate the overall safety of the medical device and performance of Auralya® dermal filler in terms of absolute change of Wrinkle Severity Rating Scale assessed by Investigator at 8 and 12 weeks after the initiation of treatment, compared to Baseline Visit (day 0). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global evaluation of product performance | 12 weeks | Global evaluation of product performance by Investigator with photos taken at each visit. The photos will be compared in the final visit (week 12) |
| Change of Wrinkle Severity Rating Scale | 12 weeks | Absolute change of WSRS score assessed by the subject at 2, 4, 8 and 12 weeks compared to Baseline Visit (day 0). |
| General appearance after treatment | 12 weeks | General appearance after treatment assessed by the subject at 2, 4, 8 and 12 weeks after the first treatment session compared to Baseline Visit (day 0) using the Global Aesthetic Improvement Scale (GAIS) |
| Subject satisfaction | 12 weeks | Subject satisfaction assessed at 2, 4, 8 and 12 weeks, through Treatment Satisfaction Questionnaire completed by the subject providing their degree of satisfaction with the treatment on a three-point scale (very satisfied, satisfied, or not satisfied) |
| Product safety | 12 weeks | Global evaluation of product safety by Investigator and by the patient using Patient Global Assessment of Safety questionnaire |
Countries
Romania
Outcome results
None listed