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

NCT03833687 | Completed

• 1 other identifier: E0918
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Flaccidity and Roughness of the Abdomen and Inner Arms

Outcome Measures

Primary Outcomes (7)

• 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)

• Change from baseline of skin plastoelasticity

  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).

  Baseline (T0), 1 month (T1), 4 months (T2)

• Change from baseline of photographic documentation

  2D pictures of the abdomen and inner arm

  Baseline (T0), 1 month (T1), 4 months (T2)

Study Arms (1)

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

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.

Profhilo®

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female sex;
• age 40-65 years;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Derming SRL: lead

Study Sites (1)

DERMING

Milan, MI, 20159, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 7, 2019
• Study Start: September 11, 2018
• Primary Completion: February 6, 2019
• Study Completion: February 6, 2019
• Last Updated: February 8, 2019

Record last verified: 2019-02

Locations

IT (1)