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

Study acronym: HA35-ITCH
StatusCompleted
PhaseNot applicable
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Completed without a posted recruiting period
    • Eligibility criteria expanded, about 9 words
  2. Minor Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07580911
Lead Sponsor Nakhia Impex LLC
Conditions
(from sponsor)
Skin Pruritus, Itch, Eczema Itch, Neurodermatitis, Insect Bite Itch, Urticaria, Postoperative Wound Pruritus
Related terms Neurodermatitis, Pruritus, Urticaria
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov