Aesthetic Performance and Tolerance of an Injective Intradermal Treatment for the Skin Roughness … (NCT05590364) | Clinical Trial Compass
CompletedNot Applicable
Aesthetic Performance and Tolerance of an Injective Intradermal Treatment for the Skin Roughness and Laxity of Back of the Hands
Italy51 participantsStarted 2022-11-07
Plain-language summary
People lose collagen all over the body, not just in the face; skin roughness and laxity of the dorsum of the hands can result from chrono and photo-aging. This skin roughness and laxity can range from very mild to severe; injection procedures can provide new tone and firmness to the skin of the hand dorsum. Dermal fillers are the most used non-permanent injectable materials available today to correct skin flaccidity and roughness on the dorsum of the hands. They give immediate aesthetic effect due to elastic gel matrix injected and impart longer term effects due to bio stimulation, promoting new collagen formation. The objective of this study is to investigate the aesthetic performance of the Hyaluronic acid (HA)- based dermal filler Profhilo® Body injected by a blunt tip microcannula (25G or 22G, preferably 22G), with fanning technique through a single entry point performing 5 passages and injecting 0,3 ml per passage, 1,5 ml for each hand. Volunteers of both sexes, aged 18-65 years with mild-moderate skin roughness and laxity at the level of hand dorsum are to be treated.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
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: Will be included in the study volunteers with the following characteristics:
* female and male sex, not necessarily 1:1 ratio;
* age 18-65 years;
* asking for hands 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 hands;
* accepting not to expose their hands to strong UV irradiation (UV session, or sun bathes) during the entire duration of the study, without appropriate sun protection;
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;
* Body Mass Index (BMI) variation (± 1) during the study period;
* performing non-surgical skin aesthetic procedures for hands in the 6 months prior to the study start;
* aesthetic surgical procedure for the hands in the past;
* change in the normal habits regarding food, physical activity, cosmetic products and cleansing for the hands 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.)
* presence of cutaneous disease on the tested area, as …
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
1
Change from Baseline of Skin Roughness and flaccidity at 30 days and at 120 days post-injection
Timeframe: Day 0, Day 30, Day 120
2
Change from Baseline of Skin density (profilometry) at 30 days and at 120 days post-injection
Timeframe: Day 0, Day 30, Day 120
3
Change from Baseline of Superficial and deep skin plastoelasticity at 30 days and at 120 days post-injection
Timeframe: Day 0, Day 30, Day 120
4
Change from Baseline of Tissue dielectric constant value of superficial and deep skin layers at 30 days and at 120 days post-injection
Timeframe: Day 0, Day 30, Day 120
5
Change from Baseline of Photographic evaluation at 30 days and at 120 days post-injection