Clinical Benefits and Safety of Combined Polynucleotides and Hyaluronic Acid - Newest - for Acne … (NCT05936437) | Clinical Trial Compass
CompletedNot Applicable
Clinical Benefits and Safety of Combined Polynucleotides and Hyaluronic Acid - Newest - for Acne Scars Treatment
Italy30 participantsStarted 2023-11-16
Plain-language summary
This clinical study wants to evaluate the efficacy and safety of a medical device combining "Polynucleotide Highly Purified Technology" (PN-HPT™) and hyaluronic acid (Newest-Mastelli S.r.l) for treating moderate-to-severe atrophic post-acne scars.
Who can participate
Age range
20 Years – 60 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
. Men and women, with age ≥ 20 and ≤ 60 years with an approximately symmetric number of atrophic acne scars on the whole face;
. Subject presenting a grade 3 to 4 according to Goodman classification corresponding to moderate-to-severe atrophic post-acne facial scars;
. Scar lesions have not be active
. Subject who never underwent surgical or laser face treatment for acne scars;
. Subjects with prior administration of oral steroids and/or isotretinoin should have interrupted this therapy at least 6 months before study kick off.
. Subject who agree to discontinue all dermatological treatment and procedures during the study;
. Subject willing to provide signed informed consent to clinical investigation participation;
. Subject able to communicate adequately with the Investigator and to comply with the requirements for the entire study
Exclusion criteria
. Patients younger than 20 or older than 60 years;
. Subjects with mild atrophic acne scars according to the Goodman classification (grade 1-2);
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.
1This trial used a combination of polynucleotides and hyaluronic acid to treat atrophic acne scars — is this type of combination treatment something my doctor thinks could be appropriate for my specific type and depth of scarring?
2The trial measured improvement using something called the Goodman Baron score — can my doctor explain what that scoring system looks at and whether my scars would be assessed the same way to track any treatment progress?
3Since this trial is already completed, has my doctor seen or reviewed any of the published results, and do the findings suggest this combination approach performed meaningfully better than treatments I might already be considering?
4This trial was listed as Phase NA, which often applies to studies of already-approved substances or devices — does that mean there's a different safety and evidence standard compared to a traditional drug trial, and how should that affect how I weigh the results?
5Are there standard or established treatments for atrophic acne scars — like laser therapy, microneedling, or fillers — that my doctor would recommend I consider alongside or before exploring a polynucleotide and hyaluronic acid combination like the one studied here?
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.
. Systemic or local illnesses that might affect wound healing
. Severe solar elastosis or scarring;
. Concomitant intake of anticoagulant or antiplatelet medications;
. Subjects who have followed a washout period of 2 weeks from topical corticosteroids, antibiotics, benzoyl-peroxide, azelaic acid, hydroxy acids, topical retinoids;
. History of autoimmune disease or chronic drug or alcohol abuse