About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- 10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Anti-Pruritic Gel