Clinical efficacy and safety of polynucleotides highly purified technology (<scp>PN‐HPT</scp>®) and cross‐linked hyaluronic acid for moderate to severe nasolabial folds: A prospective, randomized, exploratory study

Abstract

INTRODUCTION: The mandibular profile undergoes progressive wasting with aging, and the deepening of nasolabial folds (NLFs) has a leading role. Hyaluronic acid (HA) efficiently controls tissue hydration and permeability to small and large molecules. NLFs are an acknowledged HA target; at the same time, another class of agents, PN-HPT® (Polynucleotides Highly Purified Technology), enjoy growing acknowledgement in aesthetic medicine. This exploratory, prospective study probed the rationale of sequentially associating PN-HPT® as a first priming agent acting in the skin followed by HA dermal filler injections for correcting moderate to severe NLFs. METHODS: Following strict inclusion and exclusion criteria, the authors screened Caucasian ambulatory women aged 40-65 with moderate to severe NLFs and randomly selected two NLFs for each enrolled woman. Due to the purely explorative nature of the study, the authors initially planned to enroll no >10 women. According to a split-face design, the selected right-side NLFs received 4 ml of PN-HPT® intradermally in the initial priming phase ("NLF Rx group"); the selected left-side NLFs received 4 ml of saline (placebo) ("NLF Lx group"). After 3 and 6 weeks, all patients received 2 ml of subdermal cross-linked HA over both NLF areas (4 ml overall). The total study follow-up was 6 months after the first injection, with objective assessments, based on the qualitative and quantitative Antera 3D® and Vectra H2® skin imaging technologies, after 6 weeks and 3 and 6 months. RESULTS: Because of the favorable early outcomes, the authors let enrollment progress between January and June 2020 up to a total of 20 women and 40 NLFs. All treated women completed the six-month follow-up without reporting side effects, even clinically minor. The Antera 3D® device demonstrated that wrinkles and skin texture significantly improved in the NLF Rx after 6 weeks (monotherapy phase) and 3 and 6 months (PN-HPT® priming + HA phase) compared with baseline. HA levels, measured with the quantitative Vectra H2® assessment technology in the right NLFs, were significantly higher than contralaterally at both 3 and 6 months. CONCLUSIONS: Although conceived only as an exploratory investigation, the study confirmed that PN-HPT® monotherapy might be a valuable and effective option to rapidly improve the skin dermis texture and quality in individuals with moderate to severe NLFs. Acting as a priming agent in the skin, PN-HPT® prolong the clinical efficacy of cross-linked HA. Well-designed trials in larger treatment groups will hopefully confirm these early promising results.

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