A Prospective, Single-Arm, Open-Label Pilot Clinical Study to Evaluate Efficacy and Safety of Topical 10% 35 kDa Hyaluronan (HA35) Gel for Ultra-Rapid Relief of Diverse Etiology Skin Pruritus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Skin Pruritus NRS Score (0-10)
研究概览
简要总结
This is a prospective, single-arm, open-label, pilot clinical study to evaluate the efficacy and safety of topical 10% high-concentration 35 kDa hyaluronan (HA35) gel for ultra-rapid relief of moderate-to-severe skin pruritus from diverse etiologies (eczema, neurodermatitis, insect bites, urticaria, postoperative wound itch). Eligible participants will receive a single topical application of HA35 gel. The primary objective is to assess pruritus relief at 10 seconds, 45 minutes, 8 hours, 12 hours, and 24 hours post-application. Safety and local skin tolerability will be evaluated throughout the observation period. This is a minimal-risk, non-pharmacological, non-invasive intervention.
详细描述
This prospective, single-center, single-arm, open-label pilot clinical study investigates the ultra-rapid antipruritic efficacy and safety of topical 10% high-concentration 35 kDa hyaluronan (HA35) gel for managing moderate-to-severe skin pruritus caused by various conditions including eczema, neurodermatitis, insect bites, urticaria, and postoperative wound pruritus.
Eligible subjects will receive a single topical application of HA35 gel evenly spread over the pruritic skin area. Pruritus intensity will be assessed using a 0-10 Numeric Rating Scale (NRS) at baseline, 10 seconds, 45 minutes, 8 hours, 12 hours, and 24 hours after application. Changes in associated erythema, swelling, and wheals will also be observed.
Local skin irritation, allergic reactions, and adverse events will be monitored continuously for safety assessment.
This is a non-invasive, non-pharmacological topical intervention with minimal risk to participants. All procedures will be conducted in accordance with the Declaration of Helsinki, and written informed consent will be obtained from all subjects prior to enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years, male or female
- •Moderate-to-severe skin pruritus (NRS ≥6) due to eczema, neurodermatitis, insect bites, urticaria, or postoperative wound itch
- •Able to understand and complete NRS assessments independently
- •Signed written informed consent
排除标准
- •Topical corticosteroid/antihistamine use within 2 weeks
- •Infected, broken, or exudative skin lesions at the application site
- •Known hypersensitivity to hyaluronan or gel components
- •Severe systemic disease or immune dysfunction
- •Pregnant or lactating women
研究组 & 干预措施
HA35 Topical Gel Intervention Group
Participants receive a single topical application of 10% high-concentration 35 kDa HA35 gel to the pruritic skin area. Efficacy on ultra-rapid pruritus relief, duration of effect, and safety will be evaluated.
干预措施: 10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Anti-Pruritic Gel (Device)
结局指标
主要结局
Change in Skin Pruritus NRS Score (0-10)
时间窗: Baseline to 10 seconds, 45 minutes, 8 hours, 12 hours, and 24 hours after application
Change in pruritus intensity measured by 0-10 NRS, 0 = no itching, 10 = worst imaginable itching.
次要结局
- Onset time of clinically significant pruritus relief(Within 10 seconds after application)
- Duration of pruritus relief(Up to 24 hours)
- Change in Skin Erythema Severity (0-10 NRS Score)(Baseline to 45 minutes and 24 hours after application)
- Change in Local Skin Swelling Severity (0-10 NRS Score)(Baseline to 45 minutes and 24 hours after application)
- Change in Urticarial Wheal Severity (0-10 NRS Score)(Baseline to 45 minutes and 24 hours after application)