CompletedNCT03833687Updated Feb 8, 2019

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

An interventional study of Profhilo® in Skin Flaccidity and Roughness of the Abdomen and Inner Arms, sponsored by Derming SRL. Completed at 1 site in Italy. Open to female participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-08.

Sponsored by Derming SRL · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 4 months after the study started (first participant enrolled Sep 2018, registered Feb 2019).

Phase: Not applicable
Study type: Interventional
Enrollment: 24
Allocation: Not applicable
Ages: 40 Years to 65 Years
Sex: Female

Study 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 studied

Skin Flaccidity and Roughness of the Abdomen and Inner Arms

In context

Lead sponsor

Derming SRL is the lead sponsor of 26 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years to 65 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 24 participants (actual)

Study arms

Experimental
Profhilo®
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

DeviceProfhilo®
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.

What researchers measure

Primary outcomes

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).
Time frame: 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).
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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).
Time frame: Baseline (T0), 1 month (T1), 4 months (T2)
Change from baseline of photographic documentation
2D pictures of the abdomen and inner arm
Time frame: Baseline (T0), 1 month (T1), 4 months (T2)

Study locations

1 site

DERMING
Milan, MI 20159, Italy

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2018 to primary completion in Feb 2019, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered: Feb 6, 2019
First posted: Feb 7, 2019
StartActual: Sep 11, 2018
Primary completionActual: Feb 6, 2019
CompletionActual: Feb 6, 2019
Last update: Feb 8, 2019

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Feb 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03833687
Lead sponsor: Derming SRL
Responsible party: Adele Sparavigna (Medical Doctor, Derming SRL) — Principal investigator
First posted: Feb 7, 2019
Start date: Sep 11, 2018
Primary completion: Feb 6, 2019
Completion: Feb 6, 2019
Last update: Feb 8, 2019

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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