An interventional study of SUNEKOS ® 200 in Face Skin Photoaging, sponsored by Derming SRL. Completed. Open to female participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-06.
Sponsored by Derming SRL · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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.
Device: SUNEKOS ® 200
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
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.
Time frame: 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.
Time frame: Basal visit (T0), 10 days(T2i), 20 days (T3i), 30 days (T4i), 2 months (T2M) , 3 months (T3M), 6 months (T6M)
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.
Time frame: Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M)
Deep skin hydration variation
Improvement of tissue dielectric constant value of superficial and deep skin layers measured with MoistureMeterD (Delfin Technologies, Kuopio - Finland)
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M)
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Derming SRL