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

Sponsor
Nakhia Impex LLC
Study ID
NCT07569978
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
May 6, 2026
Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
Jun 10, 2026
Completion
Jul 10, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: HA35 Topical Gel Intervention Group
    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.

Primary Outcome Measure

Change in Pain Intensity NRS Score (0-10) [ Time Frame: Baseline to 2 minutes, 20 minutes, 4 hours, 8 hours, 12 hours, and 24 hours after single topical application ]

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