Eczema Itch, Insect Bite Itch, Itch, Neurodermatitis, Postoperative Wound Pruritus, Skin Pruritus, Urticaria
Conditions
Keywords
Hyaluronan, 35 kDa Hyaluronan, HA35, Topical Gel, Skin Pruritus, Itch Relief, Ultra-Rapid Relief, Anti-Pruritus, Non-Steroidal, Pilot Clinical Study
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.
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
DEVICE10% 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.
Sponsors
Nakhia Impex LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Skin Pruritus NRS Score (0-10) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 skin erythema severity at the application site, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no erythema and 10 = maximum redness. |
| Change in Local Skin Swelling Severity (0-10 NRS Score) | 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. |
| Change in Urticarial Wheal Severity (0-10 NRS Score) | 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. |
Outcome results
None listed