Aesthetic Performance of "Profhilo®" Injective Intradermal Treatment for the Neck

Skin Manifestations Clinical Trial

Official title:

Aesthetic Performance and Tolerance Evaluation of "Profhilo®" Injective Intradermal Treatment for the Skin Roughness and Laxity of the Neck

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04002856
• Other study ID #: E0319
• Status: Completed
• Phase: N/A
• Start date: February 18, 2019
• Est. completion date: June 21, 2019

Study information

• Verified date: June 2019
• Source: Derming SRL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to investigate the aesthetic performance of the Hyaluronic acid (HA)-based dermal filler Profhilo® injected by a novel bio aesthetic point technique ("BAP" techinique ) in woman aged 40-65 years with skin flaccidity and roughness of the neck.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 21, 2019
• Est. primary completion date: June 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• female sex,

• 40-65 years,

• 3-4 neck roughness/laxity grade according to a clinical reference scale;

• asking for neck 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 neck;

• accepting to not expose their neck 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 abuse and/or drug use;

• 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 neck aesthetic correction (biomaterials implants, neck lifting, botox injections, laser, chemical peeling) in the 6 months prior to the study start;

• performing permanent filler in the past;

• change in the normal habits regarding food, physical activity, neck cosmetic and cleansing use 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 9 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.

Related Conditions & MeSH terms

• Skin Manifestations

Intervention

Device:
• Profhilo®
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

Locations

Country	Name	City	State
Italy	DERMING	Milano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Derming SRL

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of neck 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)
Primary	Change from baseline of superficial skin hydration	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.	Baseline (T0), 1 month (T1), 4 months (T2)
Primary	Change from baseline of deep skin hydration	Tissue dielectric constant value of superficial and deep skin layers was measured mono-laterally on the neck with MoistureMeterD (Delfin Technologies, Kuopio - Finland)	Baseline (T0), 1 month (T1), 4 months (T2)
Primary	Change from baseline of skin density	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.	Baseline (T0), 1 month (T1), 4 months (T2)
Primary	Change from baseline of skin plastoelasticity	Superficial and deep skin plastoelasticity was measured mono-laterally on the neck with the instrument Dermal Torque Meter (Dia-Stron Ltd., UK).	Baseline (T0), 1 month (T1), 4 months (T2)
Primary	Change from baseline of photographic documentation	2D pictures of the neck	Baseline (T0), 1 month (T1), 4 months (T2)