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Polynucleotides High Purification Technology: A Real-World Prospective Study in a Hospital Outpatient Setting
Emanuele Bartoletti1, Gloria Trocchi1, Ilenia Fiorini1
1Clinical Trial Center, Servizio Ambulatoriale di Medicina Estetica e del Benessere Psicofisico nella Patologia (SAMEst), Gemelli Isola Hospital, Rome, Italy.
Introduction:
A double-blind, placebo-controlled trial demonstrated that Polynucleotides High Purification Technology (PN HPT) are an effective regenerative medicine treatment for moderate-to-severe atrophic post-acne scars. This prospective cohort study combined PN HPT with hyaluronic acid to confirm the previously reported highly controlled results in real-world outpatients.
Methods:
The study, conducted in a hospital outpatient setting, included 30 women and men aged 20 to 60 years who sought treatment for moderate-to-severe post-acne atrophic scars (Goodman-Baron grades 3-4). Treatment: PN HPT 10 mg/mL, hyaluronic acid sodium salt 10 mg/mL, and mannitol in an isotonic, buffered, viscoelastic hydrogel (CE-marked Class III Newest® medical device, Mastelli Srl, Sanremo, Italy; 30 microdrops or 0.1-0.2 mL per injection site) at baseline (T0) and after 2, 4, and 6 weeks (T1, T2, and T3, respectively). Primary endpoint: Blinded assessment of changes in scar characteristics using the 4-grade Goodman-Baron scale for acne scar assessment at post-treatment follow-up visits after three (FU3) and six months (FU6), compared to T0. Secondary endpoints: Optional objective assessment of skin quality in scarred skin surface areas (using Antera 3D or QuantifiCARE) and aesthetic impact assessed by the Global Aesthetic Improvement Scale (GAIS) questionnaire.
Results:
The mean scar area decreased from 106.6±26.34 to 93.1±20.98 at FU6 (p=0.0012; 25 of 30 subjects). The mean Goodman-Baron scores declined by 18.8% at FU3 (p=0.0012) and by 22.12% at FU6 (p<0.0001). However, the Goodman-Baron classification did not improve in 30% of subjects at FU6. GAIS scores for patients and investigators at FU3 were 2.6±0.68 and 2.4±0.68, respectively.
Conclusion:
This prospective real-world cohort study supports the clinical benefit of combining PN HPT with hyaluronic acid to reduce atrophic post-acne scar area in most treated subjects. The results confirm prior studies and suggest that this regenerative approach may be effective in an outpatient setting for moderate-to-severe post-acne scarring.
