Open, Non-Comparative Study To Evaluate The Performance Of The Medical Device JANESSE®

Study Overview
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Brief Summary
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The hypothesis of this clinical investigation is that in a population of men and women affected by periocular wrinkles, lip contour wrinkles or deep facial wrinkles, will cross-linked hyaluronic acid (Janesse) significantly decrease the appearance of facial wrinkles, results observed after 4, 8 and 12 weeks.

Detailed Description
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Janesse®'s action is to increase the volume of dermal-epidermal tissue based on the natural ability of hydrophilic hyaluronic acid molecules to bind to an amount of water many times greater than their weight. This allow to fill the intradermal spaces and integrate the intercellular matrix, conferring turgidity to the tissues. The cross-linking of the hyaluronic acid contained in the product has the effect of more stable and durable filling over time. The Research Question of the present study is the following: in a population of men and women affected by periocular wrinkles, lip contour wrinkles or deep facial wrinkles, will cross-linked hyaluronic acid (Janesse®) significantly decrease the appearance of nasolabial wrinkles, results observed after 12 weeks?

Official Title
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Open, Non-Comparative Study To Evaluate The Performance And Safety Of The Medical Device JANESSE® (Hyaluronic Acid-Dermal Filler) In The Correction Of Facial Wrinkles

Conditions
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Wrinkle

Intervention / Treatment
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* Device: Janesse® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women with age > 35 and ≤ 65 years. Subjects with nasolabial wrinkles, seeking tissue augmentation treatment and willing to receive HA Filler; Subjects presenting a score of 2 (shallow wrinkles) or 3 (moderate, deep wrinkles) on the Wrinkles Severity Ranking Scale (WSRS); Subjects who agree to discontinue all dermatological treatment and procedures during the study; Subjects willing to provide signed informed consent to clinical investigation participation. Able to communicate adequately with the Investigator and to comply with the requirements for the entire study. Exclusion Criteria: Subjects who have bleeding disorder in the past or present. Use of aspirin and antiplatelet agents a week prior to treatment 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.). Use of immunosuppressive, chemotherapies, or systemic corticosteroids within 12 weeks from screening. History of anaphylaxis or severe complicated allergy symptoms. Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders or previous mental disorders that may significantly affect the study. Hypersensitivity skin reaction to the investigational device based on intradermal test results at screening. Evidence or history of autoimmune disease or compromised immune system. Treatment with anticoagulants, thrombolytics, or platelet inhibitors within 1 week prior to study participation; Prior permanent fillers or fat graft procedures around nasolabial folds. 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. History of hypersensitivity to local anesthetic of amide type or HA. History of keloid formation or hypertrophic scar on the face. Evidence of active infection on the face. Wound, scar, or skin disorder or infection around nasolabial folds that may affect the efficacy assessment. 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.). As with all dermal filler procedures, the product should not be used in vascular rich areas. 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. Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a multi-center, open-label, non-randomized, single group clinical investigation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Janesse<br>Janesse® 20 (Cross-linked Hyaluronic Acid) Injection: follow the instruction for use | Device: Janesse® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation.<br>* The subjects will receive at baseline the first IMD by the Investigator in accordance with the CIP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WSRS score assessed by the Investigator | To evaluate the overall safety of the medical device and performance of Janesse® dermal filler in terms of absolute change of WSRS score (Wrinkle Severity Rating Scale) assessed by Investigator at 4, 8 and 12 weeks after the initiation of treatment, compared to Baseline Visit (day 0). | 12 weeks | 
| AE, SAE, ADE, SADE incidence | AE, SAE, ADE, SADE incidence | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WSRS score assessed by the patient | To evaluate the performance of the medical device in terms of change of WSRS score assessed by the subject at 4, 8 and 12 weeks compared to Baseline Visit 1 (day 0). | 12 weeks | 
| Global Aesthetic Improvement Scale evaluated by the subject | Subjects will evaluate their skin appearance change compared to before the treatment, as follows: Very Much Improved (1) = Optimal cosmetic result; Much Improved (2) = Market improvement in appearance but not completely optimal. A touch-up would slightly improve the result; Improved (3) = Obvious improvement in appearance from the initial condition, but a touch-up or re-treatment is indicated; No Change (4) = The appearance is essentially the same as the original condition; Worse (5) = The appearance is worse than the original condition. | 12 weeks | 
| Treatment satisfaction questionnaire completed by the subject | To assess the subject satisfaction at 4, 8 and 12 weeks, providing their degree of satisfaction with the treatment on a four-point scale (very satisfied, satisfied, moderate or not satisfied). | 12 weeks | 
| Investigator Global Assessment of Performance (IGAP) | Investigator Global Assessment of Performance (IGAP) Investigator will make photographs at every visit (1, 2, 3, 4 and 5) of the area treated in order to evaluate the performance of the treatment at visit 5 using a 4-point scale: 1= very good performance, 2 = good performance, 3 = moderate performance and 4 = poor performance;taken at each visit. | 12 weeks | 
| Investigator Global Assessment of Safety (IGAS) | Investigator Global Assessment of Safety (IGAS) will be reported using the 4-point scale: 1= very good safety, 2 = good safety, 3 = moderate safety and 4 = poor safety. IGAS will be evaluated by the Investigator at Final visit (12 weeks), only; | 12 weeks | 
| Patient Global Assessment of Safety (PGAS) | Patient Global Assessment of Safety (PGAS) will be reported by the subject at the last visit using the 4-point scale: 1= very good safety, 2 = good safety, 3 = moderate safety and 4 = poor safety. PGAS will be evaluated by the patient at Final visit (12 weeks), only. | 12 weeks |