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Not yet recruiting NCT07580911

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

No phase Interventional Skin Pruritus Itch Eczema Itch Neurodermatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Anti-Pruritic Gel.
Who it may be relevant to
Registry conditions: Skin Pruritus, Itch, Eczema Itch, Neurodermatitis. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Device 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.

Primary outcome measures

  • Change in Skin Pruritus NRS Score (0-10) [Time frame: Baseline to 10 seconds, 45 minutes, 8 hours, 12 hours, and 24 hours after application]
Secondary outcome measures (5)
  • Onset time of clinically significant pruritus relief [Time frame: Within 10 seconds after application]
  • Duration of pruritus relief [Time frame: Up to 24 hours]
  • Change in Skin Erythema Severity (0-10 NRS Score) [Time frame: Baseline to 45 minutes and 24 hours after application]
  • Change in Local Skin Swelling Severity (0-10 NRS Score) [Time frame: Baseline to 45 minutes and 24 hours after application]
  • Change in Urticarial Wheal Severity (0-10 NRS Score) [Time frame: Baseline to 45 minutes and 24 hours after application]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07580911 · HA35202608

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗