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| Name | Class |
|---|---|
| Opera CRO, a TIGERMED Group Company | OTHER |
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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jalucomplex® 2 | Other | Jalucomplex® 2 (Linear Hyaluronic Acid) Injection: follow the instruction for use |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jalucomplex | Device | Jalucomplex is an injectable intradermal gel containing sodium salts derived from hyaluronic acid. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mihaela Frățilă, MD | SCM Dr. Roșu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SCM Dr. Rosu | Timișoara | Timiș County | 300425 | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
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| 25081082 | Background | Sudha PN, Rose MH. Beneficial effects of hyaluronic acid. Adv Food Nutr Res. 2014;72:137-176. doi: 10.1016/B978-0-12-800269-8.00009-9. |
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| 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 |
| 26893992 | Background | Mashiko T, Kinoshita K, Kanayama K, Feng J, Yoshimura K. Perpendicular Strut Injection of Hyaluronic Acid Filler for Deep Wrinkles. Plast Reconstr Surg Glob Open. 2015 Dec 9;3(11):e567. doi: 10.1097/GOX.0000000000000552. eCollection 2015 Nov. |
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