Acute Pain, Herpes Zoster, Neuropathic Pain, Postherpetic Neuralgia, Zoster-Associated Pain
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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 application | Change in zoster-associated pain intensity measured by 0-10 Numeric Rating Scale (NRS), 0 = no pain, 10 = worst imaginable pain. |
Secondary
| Measure | Time frame |
|---|---|
| Analgesic Duration | Up to 24 hours after application |