Skin ManifestationsNCT04002856

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

A study testing Profhilo® in people with Skin Manifestations, run by Derming SRL at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 40 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Skin Manifestations
What is being tested?: Profhilo®
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteItaly
Study dates: 18 Feb 2019to 21 Jun 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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);

Show all 29Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

DERMING
Milan, MI, 20159

Other trials in Italy

About this study

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

Conditions: Skin Manifestations
Being tested: Profhilo®
Medical subject headings: Skin Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04002856
Study group	Role	What they receive
Profhilo®	Experimental	The 1st treatment was performed during T0 visit, after the basal evaluations planned by the study procedure and repeated after 1 month (T1). 2 mL of Profhilo® 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 vertical-lines (3-4-3 ). The amount of product injected was 0.2 ml for each injection point. Receives: Device: Profhilo®

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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 neck with Corneometer CM825 (Courage - Khazaka, Köln, Germany). The measure of the skin capacitance properties is an indirect expression of its hydration level.
Measured: 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 neck with MoistureMeterD (Delfin Technologies, Kuopio - Finland)
Measured: 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 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.
Measured: 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 neck with the instrument Dermal Torque Meter (Dia-Stron Ltd., UK).
Measured: Baseline (T0), 1 month (T1), 4 months (T2)
Change from baseline of photographic documentation
2D pictures of the neck
Measured: Baseline (T0), 1 month (T1), 4 months (T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Feb 201921 Jun 2019

First posted1 Jul 2019
Study start18 Feb 2019
Primary completion21 Jun 2019
Study completion21 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Skin ManifestationsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04002856
Sponsor's protocol ID: E0319
Status last verified: Jun 2019
First submitted: 27 Jun 2019
Last updated: 18 Jul 2019
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Aesthetic Performance and Tolerance Evaluation of "Profhilo®" Injective Intradermal Treatment for the Skin Roughness and Laxity of the Neck
ClinicalTrials.gov ID: NCT04002856
Acronym / sponsor ID: E0319
Conditions: Skin Manifestations
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Derming SRLUniversity, hospital or other
Study start: 18 Feb 2019 (actual)
Primary completion: 21 Jun 2019 (actual)
Study completion: 21 Jun 2019 (actual)
First posted: 1 Jul 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Profhilo®	Experimental	Device: Profhilo®The 1st treatment was performed during T0 visit, after the basal evaluations planned by the study procedure and repeated after 1 month (T1). 2 mL of Profhilo® 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 vertical-lines (3-4-3 ). The amount of product injected was 0.2 ml for each injection point.

Who may qualify

Ages: 40 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (29 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Device	Profhilo®

Primary outcome

Change from baseline of neck 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 neck 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 neck 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 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.
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 neck 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 neck

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Profhilo® in people with Skin Manifestations, run by Derming SRL at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline of neck skin roughness and laxity clinical grade (time frame: Baseline (T0), 1 month (T1), 4 months (T2)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04002856.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.