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NCT Number: NCT07580911

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

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.

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Key information

Conditions

Skin Pruritus Dermatitis Eczema Itch Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Insect Bite Itch Itch Neurodermatitis Pathological Conditions, Signs and Symptoms Postoperative Wound Pruritus Pruritus Signs and Symptoms Skin Diseases Skin Diseases, Eczematous Skin Diseases, Vascular Skin Manifestations Skin and Connective Tissue Diseases Urticaria

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Anti-Pruritic Gel

Device

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.

Other names: HA35 Itch Relief Gel, Rapid Itch Relief HA35 Gel

Primary outcomes

  1. 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

    Change in pruritus intensity measured by 0-10 NRS, 0 = no itching, 10 = worst imaginable itching.

Secondary outcomes

  1. Onset time of clinically significant pruritus relief

    Time frame: Within 10 seconds after application

  2. Duration of pruritus relief

    Time frame: Up to 24 hours

  3. Change in Skin Erythema Severity (0-10 NRS Score)

    Time frame: 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.

  4. Change in Local Skin Swelling Severity (0-10 NRS Score)

    Time frame: 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.

  5. Change in Urticarial Wheal Severity (0-10 NRS Score)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nakhia Impex LLC

Industry

Registry information

Official study 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

Acronym: HA35-ITCH

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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