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

NCT07580911 | Not Yet Recruiting

• 1 other identifier: HA35202608
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Skin Pruritus; Itch; Eczema Itch; Neurodermatitis; Insect Bite Itch; Urticaria; Postoperative Wound Pruritus

Keywords

Hyaluronan; 35 kDa Hyaluronan; HA35; Topical Gel; Skin Pruritus; Itch Relief; Ultra-Rapid Relief; Anti-Pruritus; Non-Steroidal; Pilot Clinical Study

Outcome Measures

Primary Outcomes (1)

• Change in Skin Pruritus NRS Score (0-10)

  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

Secondary Outcomes (5)

• 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

Study Arms (1)

HA35 Topical Gel Intervention Group

EXPERIMENTAL

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.

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

Interventions

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.

Also known as: HA35 Itch Relief Gel, Rapid Itch Relief HA35 Gel

HA35 Topical Gel Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nakhia Impex LLC: lead

MeSH Terms

Conditions

Pruritus; Neurodermatitis; Urticaria

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dermatitis; Skin Diseases, Eczematous; Skin Diseases, Vascular; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): June 20, 2026
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-04