Evaluate The Performance And Safety Of The Medical Device Jalucomplex®

Study Overview
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Brief Summary
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The Research Question of the present study is the following: in a population of men and women affected by facial and neck wrinkles, will linear hyaluronic acid (Jalucomplex®) significantly decrease the appearance of facial and neck wrinkles, results observed after 12 weeks?

Detailed Description
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This is an open, non-comparative study for evaluating the performance and safety of the medical device Jalucomplex in the treatment of facial and neck wrinkles. Similar dermal fillers have been used in several clinical investigations in humans with a good rate of clinical success and good safety profiles. Jalucomplex®'s acts by increasing tissue volume based on the natural ability of hydrophilic hyaluronic acid molecules to bind to an amount of water far greater than their own weight. This allows the material to fill intra-dermal spaces and supplement the intercellular matrix. Linear hyaluronic acid is a polymer that represents one of the essential components of human skin, subcutaneous and connective tissue; its ability to form complexes with water molecules increases the level of tissue hydration, turgidity and plasticity.

Official Title
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Open, Non-Comparative Study To Evaluate The Performance And Safety Of The Medical Device Jalucomplex® (Hyaluronic Acid-Dermal Filler) In the Treatment Of Facial And Neck Wrinkles To Obtain Facial Rejuvanation

Conditions
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Wrinkle

Intervention / Treatment
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* Device: Jalucomplex


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 facial and neck 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: Use of aspirin and antiplatelet agents a week prior to treatment; Pregnant or lactating women; Subjects with history of allergy or hypersensitivity to the HA or to other ingredients of the dermal filler; Subjects with hypersensitivity to salicylic acid or any of its derivates; Subjects with any dermal systemic pathologies, such as systemic lupus erythematosus, psoriasis, scleroderma etc.; Subjects presenting bleeding disorders in the past or present; Hypersensitivity skin reaction to the investigational device based on intradermal test results at baseline. Subjects taking or having indications for anticoagulant therapy; Use of concomitant treatments or procedures aimed to improve skin rejuvenation over the last six months before the clinical investigation enrolment, such as chemical peeling, dermabrasion, laser resurfacing; Subjects suffering from infectious diseases including herpes simplex virus infection, active hepatitis or human immunodeficiency virus; Subjects suffering from eczema, acne and keloids; Subjects with any cutaneous manifested infection, disease or alteration; Subjects at risk in term of precautions, warnings and contra-indications referred in the package insert of the clinical investigation device; Subjects with any facial aesthetic surgery in the preceding 12 months before the clinical investigation enrolment; Subjects with any active irritation or inflammation in the target areas of injection; Subjects who received botulinum toxin A injections in the face in the preceding 6 months; Subjects unlikely to cooperate in the clinical investigation or to comply with the treatment or with the clinical investigation visits. Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days. Presence of any clinically significant medical condition judged by the investigator to preclude the patient's inclusion in the study

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Jalucomplex® 2<br>Jalucomplex® 2 (Linear Hyaluronic Acid) Injection: follow the instruction for use | Device: Jalucomplex<br>* Jalucomplex is an injectable intradermal gel containing sodium salts derived from hyaluronic acid.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and performance of Jalucomplex® dermal filler in terms of absolute change of Wrinkle Severity Rating Scale | To evaluate the overall safety of the medical device and performance of Jalucomplex® dermal filler in terms of absolute change of Wrinkle Severity Rating Scale score assessed by Investigator at 2, 4, 8 and 12 weeks after the initiation of treatment, compared to Baseline Visit (day 0). The Wrinkle Severity Rating Scale has 5 points: 5 extreme, 4 Severe, 3 moderate, 2 minore, 1 absente. A lower value after the administration of IP will signify an improvement in wrinkle condition | 84 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wrinkles Severity Ranking Scale score assessed by the patient | Wrinkles Severity Ranking Scale score assessed by the patient before and after the injection. The Wrinkle Severity Rating Scale has 5 points: 5 extreme, 4 Severe, 3 moderate, 2 minore, 1 absente. A lower value after the administration of IP will signify an improvement in wrinkle condition. | 84 days | 
| Global Aesthetic Improvement Scale evaluated by the subject | General appearance after treatment assessed by the subject at 8 and 12 weeks after the first treatment session compared to Baseline Visit (day 0) using the Global Aesthetic Improvement Scale. There are 5 grades on this scale: 1 very much improved, 2 much improved, 3 improved, 4 no change, 5 worse | 84 days | 
| Treatment satisfaction questionnaire completed by the subject | Treatment satisfaction questionnaire completed by the subject has 3 options: very satisfied, satisfied and not satisfied. A 'Very Satisfied' answer from the patient is considered a very good outcome compared with the lowest grade 'Not Satisfied' | 84 days | 
| Investigator Global Assessment of Safety | Investigator Global Assessment of Safety (IGAS) - using the 4-point scale: 1= very good safety, 2 = good safety, 3 = moderate safety and 4 = poor safety | 84 days | 
| Patient Global Assessment of Safety | It 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. | 84 days |