Clinical Benefits and Safety of Combined Polynucleotides and Hyaluronic Acid - Newest - for Acne Scars Treatment
Launched by MASTELLI S.R.L · Jun 30, 2023
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment for acne scars using a combination of polynucleotides and hyaluronic acid, which are substances that may help improve the appearance of scars on the face. The goal is to see how effective and safe this treatment is for people with moderate to severe atrophic acne scars, which are depressed scars that can occur after acne heals.
To participate, you need to be between 20 and 60 years old and have a specific type of acne scar that falls into a moderate to severe category. You should not have had any recent treatments like surgery or laser therapy for your scars, and you must be willing to pause any other skin treatments during the study. If you qualify and choose to join, you will receive the new treatment and be monitored for its effects and any potential side effects. This trial is actively looking for participants, so it's a great opportunity if you're looking for new options to address acne scars.
Gender
ALL
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
About Mastelli S.R.L
Mastelli S.r.l. is a dynamic clinical trial sponsor dedicated to advancing healthcare through innovative research and development. With a focus on a diverse range of therapeutic areas, Mastelli S.r.l. designs and conducts rigorous clinical trials to evaluate the safety and efficacy of novel treatments. The organization is committed to upholding the highest standards of ethical practices and regulatory compliance, ensuring the integrity of its research and the well-being of participants. Leveraging a team of experienced professionals and state-of-the-art methodologies, Mastelli S.r.l. strives to contribute significantly to medical science and improve patient outcomes globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Roma, , Italy
Patients applied
Trial Officials
Emanuele Bartoletti, MD
Principal Investigator
Director of the International School of Aesthetic Medicine of the Fatebenefratelli Foundation
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported