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 in Subjects With Herpes Zoster-Associated Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Change in Pain Intensity 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 in subjects with herpes zoster-associated pain (ZAP). Eligible participants will receive a single topical application of the study gel. The primary objective is to assess rapid pain reduction within 2 minutes and 24hours after application. Secondary objectives include evaluation of analgesic duration, local tolerability, erythema improvement, and overall safety throughout the observation period. This is a minimal-risk, non-pharmacological supportive care intervention.
详细描述
This prospective, single-center, single-arm, open-label pilot clinical study investigates the analgesic efficacy and safety of topical 10% high-concentration 35 kDa hyaluronan (HA35) gel for the management of herpes zoster-associated pain (ZAP), including acute zoster pain and postherpetic neuralgia (PHN).
Eligible subjects will receive a single topical application of HA35 gel to the affected skin area. Pain intensity will be evaluated using a 0-10 Numeric Rating Scale (NRS) at baseline, 2 minutes, 20 minutes, 4 hours, 8 hours, 12 hours, and 24 hours after application.
Local skin reactions, erythema, swelling, and all adverse events will be monitored for safety assessment.
This study uses 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85 years, male or female
- •Clinically diagnosed with herpes zoster-associated pain (acute ZAP or PHN)
- •Baseline pain NRS score ≥5
- •Ability to understand and complete NRS assessments
- •Signed written informed consent
排除标准
- •Acute bacterial skin infection at the application site
- •Use of topical analgesics or antiviral therapy within 24 hours
- •Systemic analgesic use within 6 hours
- •Known hypersensitivity to hyaluronan or gel components
- •Pregnant or lactating women
- •Severe systemic disease or malignant tumor
研究组 & 干预措施
HA35 Topical Gel Intervention Group
Participants will receive a single topical application of 10% high-concentration 35 kDa hyaluronan (HA35 gel) to the affected skin area. Pain intensity, analgesic onset, duration, and local safety will be evaluated.
干预措施: 10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Analgesic Gel (Device)
结局指标
主要结局
Change in Pain Intensity NRS Score (0-10)
时间窗: Baseline to 2 minutes, 20 minutes, 4 hours, 8 hours, 12 hours, and 24 hours after single topical application
Change in zoster-associated pain intensity measured by 0-10 Numeric Rating Scale (NRS), 0 = no pain, 10 = worst imaginable pain.
次要结局
- Analgesic Duration(Up to 24 hours after application)