NCT05936437

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

November 16, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2025

Completed
Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

1.7 years

First QC Date

June 13, 2023

Last Update Submit

August 7, 2025

Conditions

Atrophic Scar

Keywords

Post-acne atrophic scarsPolynucleotidesHyaluronic acidMastelliAcne scarsNewest

Outcome Measures

Primary Outcomes (1)

  • Goodman Baron score

    The primary end-point of the study is the blinded assessment of variations of scar characteristics evaluated through the Goodman Baron score at scheduled visits versus baseline visit (T1)

    6 months

Secondary Outcomes (3)

  • Skin quality difference

    6 months

  • Global Aesthetic Improvement Scale

    6 months

  • Adverse events (AE)

    6 months

Study Arms (1)

Study arm

EXPERIMENTAL

Eligible subjects aged 20 to 60 years and in good general health, with grade 3 to 4 moderate-to-severe atrophic post-acne scars according to the Goodman Baron classification

Device: Subjects treated with Newest medical device

Interventions

Subjects treated with Newest medical deviceDEVICE

Newest is a sterile, non-pyrogenic, viscoelastic gel for single use for intradermal infiltrations. Newest is a medical device containing 2ml of the original association of polynucleotides (10mg/ml) and hyaluronic acid (10mg/ml). Total number of treatments will consist in 4 Newest administrations: at T0 - basal, at T1- 2 weeks, at T2 - 4 weeks, at T3- 6 weeks.

Study arm

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatebenefratelli Hospital

Roma, Italy

Location

Related Publications (1)

  • Araco A, Araco F. Preliminary Prospective and Randomized Study of Highly Purified Polynucleotide vs Placebo in Treatment of Moderate to Severe Acne Scars. Aesthet Surg J. 2021 Jun 14;41(7):NP866-NP874. doi: 10.1093/asj/sjab125.

    PMID: 33755110BACKGROUND

Study Officials

  • Emanuele Bartoletti, MD

    Director of the International School of Aesthetic Medicine of the Fatebenefratelli Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2023

First Posted

July 7, 2023

Study Start

November 16, 2023

Primary Completion

July 24, 2025

Study Completion

July 24, 2025

Last Updated

August 12, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)