背景：

敏感性皮肤作为全球性皮肤问题，影响着约40%-70%的人群。该疾病的发生与多个因素有关，包括皮肤屏障功能的损害、神经感觉的异常以及血管反应能力的增强等。当前临床管理多聚焦于屏障修复和抗炎治疗，但对即刻症状缓解和长期耐受性改善仍存在局限性。医用敷料作为新兴的辅助治疗手段，其安全性和有效性亟需循证依据支持。本研究针对主要成分为透明质酸钠的医用创面敷料开展临床观察，通过标准化的主观症状评估和客观指标监测，探讨其对敏感性皮肤的即时舒缓效应和持续修复作用。研究采用自身前后对照设计，结合受试者自我评价问卷与医生临床评估，系统分析该产品在改善皮肤敏感状态方面的临床价值，为敏感性皮肤管理提供新的循证医学依据。

目的：

评估含透明质酸钠医用创面敷料在缓解皮肤敏感与修复屏障方面的疗效与安全性。

方法：

1、本研究为前瞻性、自身前后对照临床试验。招募2022年9月至2023年2月期间在中国医学科学院皮肤病医院门诊就诊，且符合《中国敏感性皮肤诊疗专家共识（2017年）》诊断标准的敏感性皮肤患者。

2、使用频率：前14天每隔1天使用1次透明质酸钠医用创面敷料（第1、3、5、7、9、11、13天），后14天每隔两天使用1次（第15、18、21、24、27天），全程共28天。使用方法：洁面后取敷料覆盖于双面颊部，敷贴20分钟后去除，清水洗净，恢复常规护肤。研究期间受试者的护肤、化妆、防晒等日用产品须保持不变，不得加入其他外用产品或抗敏药物。

3、主要观察指标包括：皮肤屏障功能评估：采用水分检测仪和TEWL测定仪于基线、第14天和第28天分别检测双侧面颊角质层含水量和经皮水分丢失量；受试者评估：受试者完成主观症状自评问卷，量化紧绷、干燥、灼热、刺痛、瘙痒、脱屑、红斑等不适感；研究者评估：研究者结合VISIA-CR等设备评估面部可见红斑和潮红区域变化。安全性评估包括干预期间不良反应记录及耐受性综合评价。统计学方法采用t检验及重复测量方差分析，P<0.05为差异有统计学意义。

结果：

全体30例受试者均严格按照方案完成28天干预及随访，期间无一例因不良反应退出研究，受试者年龄22~55岁，平均年龄37.93±4.6岁。

干预14天后，皮肤屏障功能显示，双侧面颊皮肤含水量及TEWL与基线相比无统计学差异（P>0.05）；28天后，皮肤含水量略有下降，TEWL略有升高（均P>0.05）。受试者问卷调查显示紧绷、干燥、鳞屑、灼热、刺痛、瘙痒、泛红、红斑及毛细血管扩张等不适症状显著改善（P<0.05）。研究者评估显示，受试者面部潮红及红斑较基线明显改善（P<0.05）。在整个研究过程中，未发现相关不良反应，包括水肿、丘疹、水疱等。全部受试者使用产品过程舒适，未见明显刺激性或致敏风险，综合显示本产品具有良好耐受性和安全性。

结论：

含有透明质酸钠的医用敷料可以有效缓解敏感性皮肤患者的主观症状，减轻每日生活中的不适与困扰，且具有良好的安全性和耐受性。该产品作为敏感性皮肤的辅助治疗和日常养护推荐选项，具有积极意义。未来可结合发病机制、客观标志物分型等方面进一步完善评价体系，为精准化个体干预提供参考。

Background:

Sensitive skin, affecting 40%-70% of the global population, represents a multifaceted dermatological concern characterized by impaired barrier function, neurosensory abnormalities, and vascular hyperreactivity. Current therapeutic strategies predominantly focus on barrier restoration and anti-inflammatory interventions, yet challenges persist in achieving immediate symptom relief and sustained tolerance. The emerging application of medical dressings as adjuvant therapy necessitates robust clinical validation. This self-controlled clinical study evaluates the efficacy of La Roche-Posay’s medical wound dressing in managing sensitive skin. Utilizing a comprehensive assessment protocol that incorporates both subjective symptom scoring (11 indicators including stinging, burning, and erythema) and objective clinical parameters, the research investigates the product’s immediate soothing effects and long-term reparative benefits. The study design features a longitudinal approach with baseline (week 0) and follow-up (week 4) evaluations through validated patient-reported outcome measures and physician assessments. By employing rigorous statistical analysis of symptom severity scales and adverse reaction monitoring, this investigation aims to establish evidence-based insights into the product’s clinical performance. The findings are expected to contribute novel perspectives on the role of specialized dressings in sensitive skin management, addressing current gaps in non-pharmacological intervention strategies while providing guidance for optimizing skincare regimens in clinical practice.

Objective:

To evaluate the efficacy and safety of a sodium hyaluronate medical wound dressing in alleviating skin sensitivity and repairing the skin barrier in patients with sensitive skin.

Methods:

1. Study Design 

This was a prospective, self-controlled, before-after clinical trial. Participants were recruited from the outpatient department of the Institute of Dermatology, Chinese Academy of Medical Sciences between September 2022 and February 2023. All subjects met the diagnostic criteria outlined in the Chinese Expert Consensus on Diagnosis and Treatment of Sensitive Skin (2017).

2. Intervention Protocol

The application regimen comprised two phases: during the first 14 days, sodium hyaluronate medical wound dressing was applied every other day (on days 1, 3, 5, 7, 9, 11, and 13), followed by applications every three days during the subsequent 14 days (on days 15, 18, 21, 24, and 27), totaling 28 days. Post-cleansing, the dressing was applied bilaterally on the cheeks for 20 minutes before removal and rinsing with water, after which participants resumed their routine skincare. Throughout the study, subjects maintained their original skincare, cosmetic, and sun protection products, with no additional topical agents or anti-allergy medications permitted.

3. Outcome Measures

Primary endpoints included: (1) Skin barrier function: Stratum corneum hydration and transepidermal water loss (TEWL) were measured bilaterally using a corneometer and TEWL analyzer at baseline, day 14, and day 28. (2) Patient-reported outcomes: Participants completed symptom severity questionnaires quantifying subjective sensations (tightness, dryness, burning, stinging, pruritus, desquamation, erythema). (3) Investigator assessments: Facial erythema and flushing were evaluated using VISIA-CR imaging system. Safety evaluation encompassed adverse event monitoring and comprehensive tolerance assessments. Statistical analyses employed paired t-tests and repeated-measures ANOVA, with P < 0.05 considered statistically significant.

Results:

All 30 participants strictly adhered to the protocol and completed the 28-day intervention and follow-up, with no dropouts due to adverse reactions. The age of participants ranged from 22 to 55 years, with an average of 37.93±4.6 years.

After 14 days of treatment, there were no statistically significant differences in skin hydration or TEWL of both cheeks compared to baseline (P>0.05); after 28 days, skin hydration slightly decreased and TEWL slightly increased (both P>0.05). Participant self-assessment showed significant improvement in discomfort symptoms such as tightness, dryness, desquamation, burning, stinging, itching, flushing, erythema, and capillary dilation (P<0.05). Investigator assessments also indicated significant improvement in flushing and erythema compared to baseline (P<0.05). Throughout the study, no related adverse reactions such as edema, papules, or blisters were observed. The majority of participants and investigators rated the product as comfortable to use, with no obvious irritation or sensitization risk, collectively indicating good tolerability and safety of the product.

Conclusion:

Sodium hyaluronate-containing medical dressing can effectively alleviate subjective symptoms in patients with sensitive skin, reduce daily discomfort and distress, and has good safety and tolerability. As an adjunctive treatment and daily care option for sensitive skin, this product holds positive significance. Future studies may further improve the evaluation system by integrating pathogenesis and objective biomarker-based subtyping, providing a reference for more precise individualized interventions.