About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- 10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Analgesic Gel
Treatment groups
Locations
Sponsors and collaborators
Nakhia Impex LLC
Lead sponsor