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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
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 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.

Eligibility criteria

Qualifiers

Age 18-85 years, male or female

Clinically diagnosed with herpes zoster-associated pain (acute ZAP or PHN)

Baseline pain NRS score ≥5

Ability to understand and complete NRS assessments

Disqualifiers

Acute bacterial skin infection at the application site

Use of topical analgesics or antiviral therapy within 24 hours

Systemic analgesic use within 6 hours

Known hypersensitivity to hyaluronan or gel components

Trial design

Treatments tested in this trial

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

Treatment groups

30 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators