Aesthetic Performance of "Profhilo®" Injective Intradermal Treatment for the Neck
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|ClinicalTrials.gov Identifier: NCT04002856|
Recruitment Status : Completed
First Posted : July 1, 2019
Last Update Posted : July 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Skin Manifestations||Device: Profhilo®||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Aesthetic Performance and Tolerance Evaluation of "Profhilo®" Injective Intradermal Treatment for the Skin Roughness and Laxity of the Neck|
|Actual Study Start Date :||February 18, 2019|
|Actual Primary Completion Date :||June 21, 2019|
|Actual Study Completion Date :||June 21, 2019|
The 1st treatment was performed during T0 visit, after the basal evaluations planned by the study procedure and repeated after 1 month (T1).
2 mL of Profhilo® was injected into the middle-deep dermis by needle (29 G) using a bolus technique called "BAP" (Bio Aesthetic Point technique); this technique involves a series of 10 micro-wheals on 3 vertical-lines (3-4-3 ). The amount of product injected was 0.2 ml for each injection point.
Profhilo® (IBSA Farmaceutici Italia S.r.l.) is a resorbable medical device 2.25 ml non-pyrogenic pre-filled syringe, containing 2 ml of 3.2% hyaluronic acid for intradermal use (32 mg H-HA + 32 mg L-HA dissolved in 2 ml of saline buffered sodium chloride
- Change from baseline of neck skin roughness and laxity clinical grade [ Time Frame: Baseline (T0), 1 month (T1), 4 months (T2) ]Skin roughness and laxity clinical grade, according to a visual score from 1 (no roughness and flaccidity) to 5 (very severe roughness and flaccidity).
- Change from baseline of superficial skin hydration [ Time Frame: Baseline (T0), 1 month (T1), 4 months (T2) ]Skin electrical capacitance value was measured mono-laterally on the neck with Corneometer CM825 (Courage - Khazaka, Köln, Germany). The measure of the skin capacitance properties is an indirect expression of its hydration level.
- Change from baseline of deep skin hydration [ Time Frame: Baseline (T0), 1 month (T1), 4 months (T2) ]Tissue dielectric constant value of superficial and deep skin layers was measured mono-laterally on the neck with MoistureMeterD (Delfin Technologies, Kuopio - Finland)
- Change from baseline of skin density [ Time Frame: Baseline (T0), 1 month (T1), 4 months (T2) ]A little skin area of about 7 cm2 at level of neck was pinched, in standardized conditions, using a specific device. Because of this "pinch" the skin profile changes depending on cutaneous density; when the skin is slack the "pinch" forms a lot of wrinkles. A picture of the skin pinched was taken thanks to Primos compact portable device (GFMesstechnik); Primos software is able to measure skin principal profilometric parameters.
- Change from baseline of skin plastoelasticity [ Time Frame: Baseline (T0), 1 month (T1), 4 months (T2) ]Superficial and deep skin plastoelasticity was measured mono-laterally on the neck with the instrument Dermal Torque Meter (Dia-Stron Ltd., UK).
- Change from baseline of photographic documentation [ Time Frame: Baseline (T0), 1 month (T1), 4 months (T2) ]2D pictures of the neck
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002856
|Milano, MI, Italy, 20159|