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-HPTâ„¢) and hyaluronic acid (Newest-Mastelli S.r.l) for treating moderate-to-severe atrophic post-acne scars.
Who can participate
Age range20 Years – 60 Years
SexALL
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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);
✕. Pregnancy or breastfeeding women;
✕. Systemic or local illnesses that might affect wound healing
✕. 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