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Efficacy and tolerance evaluation of an intradermal injective treatment
Primary end point of the study was to evaluate clinically and by non-invasive instrumental evaluations tolerance and efficacy of SUNEKOS ® 200 injectable treatment on main sign of face skin photoaging; the micro-injections of the study product were performed by a specialized dermatologist, bilaterally on the face (zygomatic protuberance, nostril's angle, inferior margin of tragus, lip marionette lines, mandibular angle) of female volunteers aged 45-65 years, with photoaging of mild/moderate grade.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SUNEKOS ® 200 | Experimental | The 1st intradermal treatment (T1i) was performed during the basal visit (T0), after basal evaluations planned by the study procedure and repeated after 10 (T2i), 20 (T3i) and 30 (T4i) days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SUNEKOS ® 200 | Device | micro-injections of the study product were performed by a specialized dermatologist, bilaterally on the face (zygomatic protuberance, nostril's angle, inferior margin of tragus, lip marionette lines, mandibular angle) of female volunteers aged 45-65 years, with photoaging of mild/moderate grade |
| Measure | Description | Time Frame |
|---|---|---|
| Variation of Wrinkle Severity Rating Scale (WSRS) grade | Reduction of wrinkles severity corresponding to a decrease from the baseline of the Wrinkle Severity Rating Scale (WSRS) clinical score where: Grade 1 (absent): no visible nasolabial fold; continuous skin line. Grade 2 (mild): shallow but visible nasolabial fold with a slight indentation; minor facial feature. Grade 3 (moderate): moderately deep nasolabial folds; clear facial feature visible at normal appearance but not when stretched. Grade 4 (severe): very long and deep nasolabial folds; prominent facial feature; <2mm visible fold when stretched. Grade 5 (very severe): extremely deep and long nasolabial fold, detrimental to facial appearance; 2-4 mm visible V-shaped fold when stretched. | Basal visit (T0), 10 days(T2i), 20 days (T3i), 30 days (T4i), 2 months (T2M) , 3 months (T3M), 6 months (T6M) |
| Variation of Facial Volume Loss Scale (FVLS) grade | Reduction of face volume loss corresponding to a decrease from the baseline of the Facial Volume Loss Scale (FVLS) where Grade 1 Mild flattening or shadowing of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas). No prominent bony landmarks. No visibility of underlying musculature. Grade 2 An intermediate point between grade 1 and grade 3. Grade 3 Moderate concavity of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas. Prominence of bony landmarks. May have visibility of underlying musculature. Grade 4 An intermediate point between grade 3 and grade 5. Grade 5 Severe indentation of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas). Severe prominence of bony landmarks. Clear visibility of underlying musculature. | Basal visit (T0), 10 days(T2i), 20 days (T3i), 30 days (T4i), 2 months (T2M) , 3 months (T3M), 6 months (T6M) |
| Measure | Description | Time Frame |
|---|---|---|
| Superficial skin hydration variation | Improvement of skin electrical capacitance value measured with Corneometer CM825 (Courage - Khazaka, Köln, Germany). The measure of the skin capacitance properties is an indirect expression of its hydration level. | Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M) |
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Inclusion Criteria:
Exclusion Criteria:
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| Deep skin hydration variation |
Improvement of tissue dielectric constant value of superficial and deep skin layers measured with MoistureMeterD (Delfin Technologies, Kuopio - Finland) |
| Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M) |
| Skin plastoelasticity variation | Improvement of the principal torsiometric parameters Ue (immediate extensibility), Uf (final extensibility), Uv (viscoelasticity) and Ur (immediate elastic recovery).Skin firmness is measured with the instrument Dermal Torque Meter (Dia-Stron Ltd., UK). | Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M) |
| Variation of profilometric parameters | Reduction of the crow's feet lines profilometric parameters versus baseline where Ra is average roughness of the analysed profile, Rt is wrinkles total high, Rv is wrinkles maximum depth. | Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M) |
| Photographic documentation (3D pictures ) | Three-dimensional pictures of the face taken by VECTRA H1 handheld imaging system. | Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M) |
| Face volume variation | Face volume image analysis was carried on the 3D pictures taken by Vectra H1 thanks to Vectra analysis module (VAM) software | Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M) |