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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNakhia Impex LLC

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

Treatment groups

30 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators