Completed

NCT Number: NCT03833687

Aesthetic Performance of an Injective Treatment for the Skin Roughness and Laxity of Inner Arm and Abdomen

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

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Key information

Conditions

Skin Flaccidity and Roughness of the Abdomen and Inner Arms

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

DERMING

Milan, MI, 20159, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

Change from baseline of arm 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 abdomen 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 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.
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 right or left inner arm and hemiabdomen 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 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.
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 right or left inner arm and hemiabdomen 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 abdomen and inner arm

Sponsors and collaborators

Lead sponsor

Derming SRL

Other

Registry information

Official study title

Aesthetic Performance and Tolerance Evaluation of an Injective Intradermal Treatment for the Skin Roughness and Laxity of Inner Arm and Abdomen

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Feb 7, 2019
Registry last updated: Feb 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.