Treatment for acne scars using a combination of polynucleotides and hyaluronic acid

An Open-label Study Evaluating the Clinical Benefits and Safety of Combined Polynucleotides and Hyaluronic Acid - Newest - for Acne Scars Treatment

This study is testing a new treatment that combines special ingredients to see if it can help reduce moderate-to-severe acne scars in people.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 20 Years to 60 Years
• Sex: All
• Sponsor: Mastelli S.r.l (industry)
• Locations: 1 site (Roma)
• Trial ID: NCT05936437 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the efficacy and safety of a medical device that combines Polynucleotide Highly Purified Technology (PN-HPT™) and hyaluronic acid for treating moderate-to-severe atrophic post-acne scars. Conducted at Fatebenefratelli Hospital in Rome, Italy, the study involves a prospective, open-label design with a sample size of 30 patients. Participants will undergo assessments at multiple time points over six months to measure improvements in scar characteristics using the Goodman Baron scale. The study aims to demonstrate a significant reduction in acne scar severity following treatment.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 20 to 60 with moderate to severe atrophic acne scars who have not undergone previous surgical or laser treatments.

Not a fit: Patients with mild atrophic acne scars or those who have had prior surgical or laser treatments for acne scars may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the appearance of acne scars for patients suffering from moderate to severe atrophic scars.

How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. Men and women, with age ≥ 20 and ≤ 60 years with an approximately symmetric number of atrophic acne scars on the whole face;
2. Subject presenting a grade 3 to 4 according to Goodman classification corresponding to moderate-to-severe atrophic post-acne facial scars;
3. Scar lesions have not be active
4. Subject who never underwent surgical or laser face treatment for acne scars;
5. Subjects with prior administration of oral steroids and/or isotretinoin should have interrupted this therapy at least 6 months before study kick off.
6. Subject who agree to discontinue all dermatological treatment and procedures during the study;
7. Subject willing to provide signed informed consent to clinical investigation participation;
8. Subject able to communicate adequately with the Investigator and to comply with the requirements for the entire study

Exclusion Criteria:

1. Patients younger than 20 or older than 60 years;
2. Subjects with mild atrophic acne scars according to the Goodman classification (grade 1-2);
3. Pregnancy or breastfeeding women;
4. Systemic or local illnesses that might affect wound healing
5. Severe solar elastosis or scarring;
6. Concomitant intake of anticoagulant or antiplatelet medications;
7. Subjects who have followed a washout period of 2 weeks from topical corticosteroids, antibiotics, benzoyl-peroxide, azelaic acid, hydroxy acids, topical retinoids;
8. History of autoimmune disease or chronic drug or alcohol abuse

Where this trial is running

Roma

• Fatebenefratelli Hospital — Roma, Italy (RECRUITING)

Study contacts

• Principal investigator: Emanuele Bartoletti, MD — Director of the International School of Aesthetic Medicine of the Fatebenefratelli Foundation
• Study coordinator: Cristina Iaru, MD

Conditions: Atrophic Scar, Post-acne atrophic scars, Polynucleotides, Hyaluronic acid, Mastelli, Acne scars, Newest