Aesthetic Performance of an Injective Treatment for the S... | NCT03833687

NCT03833687

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Profhilo®	Experimental	The 1st treatment was performed during the basal visit and repeated after 1 month. 3 mL of Profhilo® for each brachial zone, 1.5 mL for hemiabdomen 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 horizontal-levels for each tested areas (3-4-3 injection points respectively for the 1st, the 2nd and the 3rd horizontal-level). The amount of product to be injected was of 0.3 ml for each point.	Device: Profhilo®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Profhilo®	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline of arm skin roughness and laxity clinical grade	Skin roughness and laxity clinical grade, according to a visual score from 1 (no roughness and flaccidity) to 5 (very severe roughness and flaccidity).	Baseline (T0), 1 month (T1), 4 months (T2)
Change from baseline of abdomen skin roughness and laxity clinical grade	Skin roughness and laxity clinical grade, according to a visual score from 1 (no roughness and flaccidity) to 5 (very severe roughness and flaccidity).	Baseline (T0), 1 month (T1), 4 months (T2)
Change from baseline of superficial skin hydration	Skin electrical capacitance value was measured mono-laterally on the right or left inner arm and hemiabdomen with Corneometer CM825 (Courage - Khazaka, Köln, Germany). The measure of the skin capacitance properties is an indirect expression of its hydration level.	Baseline (T0), 1 month (T1), 4 months (T2)
Change from baseline of deep skin hydration	Tissue dielectric constant value of superficial and deep skin layers was measured mono-laterally on the right or left inner arm and hemiabdomen with MoistureMeterD (Delfin Technologies, Kuopio - Finland)	Baseline (T0), 1 month (T1), 4 months (T2)
Change from baseline of skin density	A little skin area of about 7 cm2 (at level of inner arm 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.	Baseline (T0), 1 month (T1), 4 months (T2)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

female sex;
age 40-65 years;
3-4 abdomen and inner arm roughness/laxity grade according to a clinical reference scale;
asking for abdomen and inner arms laxity and roughness restoration;
available and able to return to the study site for the post-procedural follow-up examinations;
accepting to not change their habits regarding food, physical activity, cosmetic and cleansing products for the body;
accepting not to expose their face to strong UV irradiation (UV session, or sun bathes) during the entire duration of the study, without appropriate sun protection;
accepting to sign the informed consent form.

Exclusion Criteria:

Pregnancy;
lactation;
smokers;
alcohol or drug abusers;
subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study;
subjects not in menopause who do not accept to perform the pregnancy test at T0 (before the 1st aesthetic procedure) and at T1 (1 month after the 1st injection treatment execution, before the 2nd aesthetic procedure);
Body Mass Index (BMI) variation (± 1) during the study period;
performing skin treatments for abdominal and brachial zone aesthetic correction (carboxytherapy injections, body lifting, laser, infrared light, bipolar radiofrequency, vacuum and mechanical massage) in the 6 months prior to the study start;
aesthetic surgical procedure on abdominal and brachial zone in the past;
change in the normal habits regarding food, physical activity, cosmetic products and cleansing for the body during the month preceding the test;
sensitivity to the test product or its ingredients (to be assessed by the investigator during the baseline visit);
subjects whose insufficient adhesion to the study protocol is foreseeable;
participation in a similar study currently or during the previous 6 months.
Dermatitis;
presence of cutaneous disease on the tested area, as lesions, scars, malformations;
recurrent facial/labial herpes;
clinical and significant skin condition on the test area (e.g. active eczema, psoriasis, severe rosacea, scleroderma, local infections and severe acne).
Diabetes;
endocrine disease;
hepatic disorder;
renal disorder;
cardiac disorder;
pulmonary disease;
cancer;
neurological or psychological disease;
inflammatory/immunosuppressive disease;
drug allergy.
Anticoagulants and antiplatelet drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago);
using of drugs able to influence the test results in the investigator opinion.