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Prospective, low-interventional, multicentric, open-labelled study to assess the performance and safety of skin beautification treatment by TEOSYAL RHA® 1 for fine lines in the neck, perioral region, and smiling lines including an exploratory arm with TEOSYAL® PureSense Redensity 1 to assess skin redensification.
Treatment phase - skin beautification:
At Visit 1 (Baseline), subjects will be injected with TEOSYAL RHA® 1 in the fine lines (Neck lines and Perioral and/or Smiling lines) depending on wrinkle severity assessed by the Principal Investigator (PI) at baseline using a specific grading scale for each indication.
The subject will be included in the study if he has been graded 2 or 3 on the Neck Lines Descriptive Scale (NLDS) at baseline.
Then:
Each indication represent one cohort and all subjects will be included in the neck lines cohort.
Thus, Subject participating to the study may be treated for:
An optional touch-up will be performed at Visit 2 (Month 1 +/- 1 week) if deemed necessary to achieve an optimal correction.
Exploratory phase - skin redensification:
After treatment with TEOSYAL RHA® 1, subjects will be randomized to the second phase of the study (starting at month 2 +/- 1 week): 5/6 of the subjects will enter the exploratory part of the study during which TEOSYAL® PureSense Redensity 1 (RHA1+R1 treated Group) will be assessed for skin redensification. The rest of the subjects will not receive any additional treatment for the rest of the study (RHA1 only treated group/around 11 subjects).
Note: the number of sessions treated with Redensity 1 might be adapted depending on subject treatment needs in order to achieve optimal results. This will be at PI discretion.
Subjects in the RHA+R1 treated Group will be also randomized into 2 subgroups of 28 subjects as described below:
The principal investigator (PI) will perform the study injections. He will evaluate subject aesthetic improvement using grading scales and skin quality measurements at each study visits and assess safety and tolerability of the devices during the study. Adverse events will be monitored by the Clinical Research Associate (CRA) throughout the study.
Additionally, a Blinded Evaluator will also evaluate subject aesthetic improvement using grading scales for each follow-up visits based on photographs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEOSYAL RHA® 1 | Experimental | Subjects injected with TEOSYAL RHA® 1 during the "skin beautification" phase, not further treated with TEOSYAL® PureSense Redensity 1 during the "skin redensification" phase. |
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| TEOSYAL RHA® 1 and TEOSYAL® PureSense Redensity 1 with a needle | Experimental | Subjects injected with TEOSYAL RHA® 1 during the "skin beautification" phase, further treated with TEOSYAL® PureSense Redensity 1 using a needle during the "skin redensification" phase. |
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| TEOSYAL RHA® 1 and TEOSYAL® PureSense Redensity 1 with a cannula | Experimental | Subjects injected with TEOSYAL RHA® 1 during the "skin beautification" phase, further treated with TEOSYAL® PureSense Redensity 1 using a cannula (optional for perioral lines) during the "skin redensification" phase. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEOSYAL RHA® 1 | Device | During the first phase of the study, ubjects will be treated with TEOSYAL RHA® 1 at baseline (V1) and may receive an optional treatment at 1 month (V2). In the exploratory phase of the study, subjects will not receive any additional treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects improved or much improved on the Global Aesthetic Improvement Scale (GAIS) according to both the Principal Investigator (PI) and the subject. | The Global Aesthetic Improvement Scale (GAIS) is a subjective 5-grade scale comprised of "much improved, improved, no change, worse, and much worse". | Visit 3 (Month 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects improved or much improved on the Global Aesthetic Improvement Scale (GAIS) according to the Principal Investigator (PI) | The Global Aesthetic Improvement Scale (GAIS) is a subjective 5-grade scale comprised of "much improved, improved, no change, worse, and much worse". | Visit 2 (Month 1), Visit 3 (Month 2), Visit (Month 3), Visit 5 (Month 4), Visit 6 (Month 5) |
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Inclusion Criteria (General):
Inclusion Criteria (Cohort) 4. Healthy adult having wrinkle severity in at least one of the two indications (50% for each of the following cohort): i. Moderate to severe perioral rhytids (grade 2 or grade 3 on the PR-SRS) ii. Moderate to severe smiling lines (grade 3 or grade 4 on the SLDS)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 4 | Alicante | Spain | ||||
| Site 3 |
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| ID | Term |
|---|---|
| D009339 | Needles |
| D000072601 | Cannula |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
| D057785 | Catheters |
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| TEOSYAL RHA® 1 and TEOSYAL® PureSense Redensity 1 (needle) | Device | During the first phase of the study, ubjects will be treated with TEOSYAL RHA® 1 at baseline (V1) and may receive an optional treatment at 1 month (V2). In the exploratory phase of the study, subjects will receive additional treatment with TEOSYAL® PureSense Redensity 1 using a needle. TEOSYAL® PureSense Redensity 1 will be administered over three sessions at 2, 3 and 4 months after baseline (respectively V3, V4 and V5). |
|
| TEOSYAL RHA® 1 and TEOSYAL® PureSense Redensity 1 (cannula) | Device | During the first phase of the study, ubjects will be treated with TEOSYAL RHA® 1 at baseline (V1) and may receive an optional treatment at 1 month (V2). In the exploratory phase of the study, subjects will receive additional treatment with TEOSYAL® PureSense Redensity 1 using a cannula. TEOSYAL® PureSense Redensity 1 will be administered over three sessions at 2, 3 and 4 months after baseline (respectively V3, V4 and V5). |
|
| Proportion of subjects improved or much improved on the Global Aesthetic Improvement Scale (GAIS) according to the subject | The Global Aesthetic Improvement Scale (GAIS) is a subjective 5-grade scale comprised of "much improved, improved, no change, worse, and much worse". | Visit 2 (Month 1), Visit 3 (Month 2), Visit (Month 3), Visit 5 (Month 4), Visit 6 (Month 5) |
| Proportion of subjects improved or much improved on the Global Aesthetic Improvement Scale (GAIS) according to the Blinded Evaluator (BE) | The Global Aesthetic Improvement Scale (GAIS) is a subjective 5-grade scale comprised of "much improved, improved, no change, worse, and much worse". | Visit 2 (Month 1), Visit 3 (Month 2), Visit (Month 3), Visit 5 (Month 4), Visit 6 (Month 5) |
| Barcelona |
| Spain |
| Site 1 | Bilbao | Spain |
| Site 2 | Madrid | Spain |