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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic Duration | Up to 24 hours after application |
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Inclusion Criteria:
Exclusion Criteria:
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|
|
| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| D051474 | Neuralgia, Postherpetic |
| D009437 | Neuralgia |
| D059787 | Acute Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
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