Efficacy and Safety of High-Concentration 35 kDa Hyaluronan Gel for Herpes Zoster-Associated Pain

Study acronym: HA35-HZ
StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Minor Completed without a posted recruiting period
    • Eligibility criteria expanded, about 11 words
  2. Minor Study title shortened, about 4 wordsv2
  3. 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 in subjects with herpes zoster-associated pain (ZAP). Eligible participants will receive a single topical application of the study gel. The primary objective is to assess rapid pain reduction within 2 minutes and 24hours after application. Secondary objectives include evaluation of analgesic duration, local tolerability, erythema improvement, and overall safety throughout the observation period. This is a minimal-risk, non-pharmacological supportive care intervention.
Trial Details
NCT Number NCT07569978
Lead Sponsor Nakhia Impex LLC
Conditions
(from sponsor)
Herpes Zoster, Zoster-Associated Pain, Postherpetic Neuralgia, Neuropathic Pain, Acute Pain
Related terms Acute Pain, Agnosia, Herpes Zoster, Neuralgia, Neuralgia, Postherpetic
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov