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.
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
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
Single group
10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Anti-Pruritic Gel
DeviceTopical 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.
Change in Skin Pruritus NRS Score (0-10)
Change in pruritus intensity measured by 0-10 NRS, 0 = no itching, 10 = worst imaginable itching.
Onset time of clinically significant pruritus relief
Duration of pruritus relief
Change in Skin Erythema Severity (0-10 NRS Score)
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)
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.
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