Cosmetic and Plastic Surgeon, Aesthetic Medicine Department, Tor Vergata University, Rome, Italy.
Cosmetic and Plastic Surgeon, San Giovanni Evangelista Hospital, Tivoli, Italy.
J Cosmet Dermatol. 2023 Jan;22(1):146-155. doi: 10.1111/jocd.15064. Epub 2022 May 26.
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.
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.
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.
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.
随着年龄的增长，下颌轮廓会逐渐消瘦，鼻唇沟（NLFs）加深。透明质酸（HA）能有效控制组织的水合作用和对小分子和大分子的通透性。NLFs 是公认的 HA 靶点；与此同时，另一类药物，PN-HPT®（多核苷酸高度纯化技术）在美容医学领域的认可度也在不断提高。这项探索性、前瞻性研究探讨了将 PN-HPT® 作为一种首先作用于皮肤的初级启动剂，然后再注射 HA 真皮填充剂来纠正中重度 NLFs 的合理性。
根据严格的纳入和排除标准，作者筛选了年龄在 40-65 岁之间、有中重度 NLFs 的白种门诊女性，并为每位入组女性随机选择了两条 NLFs。由于研究纯属探索性，作者最初计划招募不超过 10 名女性。根据分割面设计，右侧选定的 NLFs 在初始启动阶段接受 4ml 的 PN-HPT®皮内注射（“NLF Rx 组”）；左侧选定的 NLFs 接受 4ml 的生理盐水（安慰剂）（“NLF Lx 组”）。3 周和 6 周后，所有患者均在双侧 NLF 区域接受 2ml 交联透明质酸皮下注射（共 4ml）。第一次注射后 6 个月进行总研究随访，采用 Antera 3D®和 Vectra H2®皮肤成像技术进行定性和定量评估，分别在 6 周、3 个月和 6 个月后进行。
由于早期结果良好，作者允许在 2020 年 1 月至 6 月期间继续招募，共招募了 20 名女性和 40 条 NLFs。所有接受治疗的女性均完成了 6 个月的随访，无不良反应报告，甚至无临床轻微不良反应报告。Antera 3D®设备显示，与基线相比，NLF Rx 在 6 周（单药治疗阶段）和 3 个月和 6 个月（PN-HPT®启动+HA 阶段）时皱纹和皮肤纹理显著改善。右侧 NLFs 中使用定量 Vectra H2®评估技术测量的 HA 水平在 3 个月和 6 个月时均明显高于对侧。
尽管该研究仅被设想为一项探索性研究，但证实了 PN-HPT®单药治疗可能是一种有价值且有效的选择，可快速改善中度至重度 NLFs 个体的皮肤真皮质地和质量。PN-HPT®作为皮肤的初级启动剂，可延长交联透明质酸的临床疗效。在更大的治疗组中进行精心设计的试验有望证实这些早期有希望的结果。
