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Efficacy and Safety of HA35 Gel for Ultra-Rapid Skin Pruritus Relief (HA35-ITCH)

2026年5月5日 更新者：Nakhia Impex LLC

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

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

30

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
设备：10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Anti-Pruritic Gel
Topical skin gel containing 10% high-concentration 35 kDa hyaluronan fragment. Applied topically to pruritic areas to provide ultra-rapid relief of skin itching and improve associated inflammatory signs.
其他名称：
  • HA35 Itch Relief Gel
  • Rapid Itch Relief HA35 Gel

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Skin Pruritus NRS Score (0-10)
大体时间：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.
Baseline to 10 seconds, 45 minutes, 8 hours, 12 hours, and 24 hours after application

次要结果测量

结果测量
措施说明
大体时间
Onset time of clinically significant pruritus relief
大体时间：Within 10 seconds after application
Within 10 seconds after application
Duration of pruritus relief
大体时间：Up to 24 hours
Up to 24 hours
Change in Skin Erythema Severity (0-10 NRS Score)
大体时间：Baseline to 45 minutes and 24 hours after application
Change in skin erythema severity at the application site, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no erythema and 10 = maximum redness.
Baseline to 45 minutes and 24 hours after application
Change in Local Skin Swelling Severity (0-10 NRS Score)
大体时间：Baseline to 45 minutes and 24 hours after application
Change in local skin swelling severity at the application site, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no swelling and 10 = maximum swelling.
Baseline to 45 minutes and 24 hours after application
Change in Urticarial Wheal Severity (0-10 NRS Score)
大体时间：Baseline to 45 minutes and 24 hours after application
Change in urticarial wheal severity at the application site, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no wheals and 10 = maximum wheal size and spread.
Baseline to 45 minutes and 24 hours after application

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Nakhia Impex LLC

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月20日

初级完成 (估计的)

2026年7月20日

研究完成 (估计的)

2026年8月20日

研究注册日期

首次提交

2026年4月29日

首先提交符合 QC 标准的

2026年5月5日

首次发布 (实际的)

2026年5月12日

研究记录更新

最后更新发布 (实际的)

2026年5月12日

上次提交的符合 QC 标准的更新

2026年5月5日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • HA35202608

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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