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

ConditionsHerpes Zoster Zoster-Associated Pain Postherpetic Neuralgia Neuropathic Pain Acute 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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

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

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: HA35 Topical Gel Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Change in Pain Intensity NRS Score (0-10)

Change in zoster-associated pain intensity measured by 0-10 Numeric Rating Scale (NRS), 0 = no pain, 10 = worst imaginable pain.

Time frame

Baseline to 2 minutes, 20 minutes, 4 hours, 8 hours, 12 hours, and 24 hours after single topical application

Secondary outcomes

Analgesic Duration

Time frame

Up to 24 hours after application

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nakhia Impex LLC

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: