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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07569978
Acronym
HA35-HZ
Enrollment
30
Registered
2026-05-06
Start date
2026-05-01
Completion date
2026-07-10
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Detailed description

This prospective, single-center, single-arm, open-label pilot clinical study investigates the analgesic efficacy and safety of topical 10% high-concentration 35 kDa hyaluronan (HA35) gel for the management of herpes zoster-associated pain (ZAP), including acute zoster pain and postherpetic neuralgia (PHN). Eligible subjects will receive a single topical application of HA35 gel to the affected skin area. Pain intensity will be evaluated using a 0-10 Numeric Rating Scale (NRS) at baseline, 2 minutes, 20 minutes, 4 hours, 8 hours, 12 hours, and 24 hours after application. Local skin reactions, erythema, swelling, and all adverse events will be monitored for safety assessment. This study uses a non-invasive, non-pharmacological topical intervention with minimal risk to participants. All procedures will be conducted in accordance with the Declaration of Helsinki, and written informed consent will be obtained from all subjects prior to enrollment.

Interventions

DEVICE10% 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

Nakhia Impex LLC
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Pain Intensity NRS Score (0-10)Baseline to 2 minutes, 20 minutes, 4 hours, 8 hours, 12 hours, and 24 hours after single topical applicationChange in zoster-associated pain intensity measured by 0-10 Numeric Rating Scale (NRS), 0 = no pain, 10 = worst imaginable pain.

Secondary

MeasureTime frame
Analgesic DurationUp to 24 hours after application

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026