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The objective of this clinical study is to confirm the clinical performance and long-term safety of the CE-marked RRS® HA Long Lasting in the treatment of skin photoaging and its consequences, with a primary focus on improving facial wrinkles and skin quality in healthy adults.
The main questions it aims to answer are: the proportion of responders achieving a clinically significant change in facial wrinkles from baseline to Month 2 on both sides of the face; improvement in photodamage compared to the control group at 2 months. Researchers will compare the group treated with RRS® HA Long Lasting to an untreated control group to evaluate the product's effectiveness in improving facial wrinkles and skin quality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Subjects will be randomized (2:1 ratio) to the RRS® HA Long Lasting (treatment) arm or the no-treatment control arm | |
| RRS® HA Long Lasting single treatment | Experimental | Treatment Group Group 1: Single injection on Day 0 |
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| RRS® HA Long Lasting double treatment | Experimental | Treatment Group Group 2: Injection on Day 0 and a second (touch-up) injection on Day 30 if improvement is scored as <1 point on SASSQ wrinkle parameter by the PI and the subject. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RRS® HA Long Lasting | Device | RRS® HA Long Lasting is a sterile medical device, Class III, dermal implant that contains cross-linked, resorbable Hyaluronic acid (HA). |
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| Measure | Description | Time Frame |
|---|---|---|
| Wrinkle Severity | The primary efficacy endpoint is the percentage of responders, defined by at least 1 point improvement from baseline in facial wrinkles as measured by the blind evaluator at 2 months post last treatment, assessed by the Scientific Assessment Scale of Skin Quality (SASSQ) wrinkle parameter, compared with no treatment control. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Wrinkle Severity |
| baseline, 1 month, 2, 3, and 6 months |
| Photodamage |
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Inclusion Criteria:
Exclusion Criteria:
In terms of population:
In terms of associated pathology:
Relating to previous or ongoing treatment:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gal·la Clinic | Recruiting | Barcelona | Catalonia | 08025 | Spain |
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Subjects will be randomized (2:1 ratio) to the RRS® HA Long Lasting (treatment) arm or the no-treatment control arm. Treatment Group includes Group 1: Single injection on Day 0 and Group 2: Injection on Day 0 and a second (touch-up) injection on Day 30 if improvement is scored as <1 point on SASSQ wrinkle parameter by the PI and the subject.
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The primary efficacy endpoint is the percentage of responders, defined by at least 1 point improvement from baseline in facial wrinkles on both sides as measured by the blind evaluator at 2 months post last treatment
| baseline, 30 days (1 month), 2, 3, and 6 months of follow-up |
| Skin texture |
| baseline, 30 days (1 month), 2, 3, and 6 months of follow-up |
| Global Aesthetic Improvement |
| 1 month, 2, 3, and 6 months of follow-up |
| Skin hydration |
| baseline, 1 month, 2, 3, and 6 months of follow-up |
| Subject & Investigator Satisfaction | Subjects and treatment investigators will answer the questionnaire to assess the satisfaction of investigational medical device performance after the treatment. | 6 months of follow-up |
| Product presence in tissue |
| before and immediately after injection, and at 6- and 12-months follow-up |
| Centre Mèdic de Cabo Bové | Recruiting | Barcelona | Catalonia | 08760 | Spain |
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| Aruma Clinic | Recruiting | Madrid | Madrid | 28001 | Spain |
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| Zurko Research, S.L. | Recruiting | Madrid | Madrid | 28023 | Spain |
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| Ocean Clinic | Recruiting | Marbella | Málaga | 29601 | Spain |
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