An interventional study of Profhilo in Malar and Sub-malar Volume Deficiency, sponsored by Derming SRL. Completed at 1 site in Italy. Open to female participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-05.
Sponsored by Derming SRL · Not applicable, Interventional, and Treatment
Primary end point of the study was to evaluate clinically and by non-invasive instrumental evaluations tolerance and efficacy of a bio-revitalizing product containing hyaluronic acid with high (H-HA) and low (L-HA) molecular weight; the micro-injection of the study product was performed by a specialized dermatologist, bilaterally on the face (zygomatic protuberance, nostril's angle, inferior margin of tragus, lip marionette lines, mandibular angle) of healthy female volunteers aged 30-60 years.
It was also aim of this study to evaluate efficacy by the volunteers and tolerance both by investigator and volunteers.
Exclusion Criteria:
The intradermal procedure was performed bilaterally on the face, at level of the following five points: 1. zygomatic protuberance 2. nostril's angle 3. inferior margin of tragus 4. lip marionette lines 5. mandibular angle. The amount of product injected, was 0.2 ml for each injection-point.
Device: Profhilo
Also known as: IBSA
Wrinkle Severity Rating Scale (WSRS) improvement
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), Week 4 (T4W) , Week 8 (T8W), Week 12 (T12W), Week 16 (T16W).
Facial Volume Loss Scale (FVLS) improvement
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: 16 weeks
Surface microrelief's regularity improvement
Improvement of skin surface microrelief corresponding to a reduction of the clinical score of microrelief's regularity grade where Grade 1:very regular, Grade 2: regular, Grade 3: irregular, Grade 4: very irregular. Clinical evaluation of surface microrelief's regularity grade is carried out on the digital picture acquired by FotoFinderDermoscope with a magnification of 20X
Time frame: Basal visit (T0), Week 4 (T4W) , Week 8 (T8W), Week 12 (T12W), Week 16 (T16W).
Determination of profilometric parameters
Reduction of the nasolabial fold and marionette lines profilometric parameters versus baseline where Ra is average roughness of the analysed profile, Rt is wrinkles total high, Rv is wrinkles maximum depth. Replicas of nasolabial fold and marionette lines are obtained using silicone rubber. A picture of the skin replicas is taken thanks to Primos compact portable device (GFMesstechnik); Primos software is able to elaborate 3D representations of skin wrinkles as well as to measure skin principal profilometric parameters.
Time frame: Basal visit (T0), Week 4 (T4W) , Week 8 (T8W), Week 12 (T12W), Week 16 (T16W).
Skin plastoelasticity improvement
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), Week 4 (T4W) , Week 8 (T8W), Week 12 (T12W), Week 16 (T16W).
Superficial skin hydration improvement
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), Week 4 (T4W) , Week 8 (T8W), Week 12 (T12W), Week 16 (T16W).
Deep skin hydration improvement
Improvement of tissue dielectric constant value of superficial and deep skin layers measured with MoistureMeterD (Delfin Technologies, Kuopio - Finland)
Time frame: Basal visit (T0), Week 4 (T4W) , Week 8 (T8W), Week 12 (T12W), Week 16 (T16W).
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Derming SRL