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

NCT07569978 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-08

No results posted yet for this study

Summary

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.

Conditions

  • Herpes Zoster
  • Zoster-Associated Pain
  • Postherpetic Neuralgia
  • Neuropathic Pain
  • Acute Pain

Interventions

DEVICE

10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Analgesic Gel

A topical, non-pharmacological gel containing 10% high-concentration 35 kDa hyaluronan fragment. It is applied topically to the affected skin area to relieve herpes zoster-associated pain, reduce inflammation, and improve local tolerability.

Sponsors & Collaborators

  • Nakhia Impex LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-06-10
Completion
2026-07-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07569978 on ClinicalTrials.gov