CompletedNot Applicable

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

Italy25 participantsStarted 2019-02-18

Plain-language 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.

Who can participate

Age range

40 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 prod…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline of neck skin roughness and laxity clinical grade

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

Change from baseline of superficial skin hydration

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

Change from baseline of deep skin hydration

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

Change from baseline of skin density

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

Change from baseline of skin plastoelasticity

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

Change from baseline of photographic documentation

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

Trial details

NCT IDNCT04002856

SponsorDerming SRL

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-06-21

View on ClinicalTrials.gov More Skin Manifestations trials

Who can participate

Age range

40 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from baseline of neck skin roughness and laxity clinical grade

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

Change from baseline of superficial skin hydration

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

Change from baseline of deep skin hydration

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

Change from baseline of skin density

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

Change from baseline of skin plastoelasticity

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

Change from baseline of photographic documentation

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