Efficacy and Safety of High-Concentration 35 kDa Hyaluronan Gel for Herpes Zoster-Associated Pain: A Pilot Clinical Study

NCT07569978 | Not Yet Recruiting

• 1 other identifier: HA35202602
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Hyaluronan; 35 kDa Hyaluronan; HA35; Topical Gel; Herpes Zoster; Zoster Pain; Postherpetic Neuralgia; Neuropathic Pain; Analgesia; Non-pharmacological Intervention; Pilot Clinical Study

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• Analgesic Duration

  Up to 24 hours after application

Study Arms (1)

HA35 Topical Gel Intervention Group

EXPERIMENTAL

Participants will receive a single topical application of 10% high-concentration 35 kDa hyaluronan (HA35 gel) to the affected skin area. Pain intensity, analgesic onset, duration, and local safety will be evaluated.

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

Interventions

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.

Also known as: HA35 Zoster Pain Gel, HA35 Analgesic Gel

HA35 Topical Gel Intervention Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Signed written informed consent

You may not qualify if:

• 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
• Pregnant or lactating women
• Severe systemic disease or malignant tumor

Sponsors & Collaborators

• Nakhia Impex LLC: lead

MeSH Terms

Conditions

Herpes Zoster; Neuralgia, Postherpetic; Neuralgia; Acute Pain; Agnosia

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 6, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 10, 2026
• Study Completion (Estimated): July 10, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04