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

Nakhia Impex

Status: Not yet enrolling

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

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07580911

HA35202608

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

HA35 Topical Gel Intervention Group

Experimental group

Description:

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.

Treatment:

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