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Efficacy and Safety of High-Concentration 35 kDa Hyaluronan Gel for Herpes Zoster-Associated Pain
Sponsor: Nakhia Impex LLC
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-05-01
Completion Date
2026-07-10
Last Updated
2026-05-08
Healthy Volunteers
No
Interventions
10% 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.