Not Yet RecruitingNot Applicable

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

30 participantsStarted 2026-05-01

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Pain Intensity NRS Score (0-10)

Timeframe: Baseline to 2 minutes, 20 minutes, 4 hours, 8 hours, 12 hours, and 24 hours after single topical application

Trial details

NCT IDNCT07569978

SponsorNakhia Impex LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-10

View on ClinicalTrials.gov More Herpes Zoster trials