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COMPLETED
NCT07568548
NA

Efficacy and Safety of High-Concentration 35 kDa Hyaluronan Gel for Chronic Nasopharyngitis

Sponsor: Nakhia Impex LLC

View on ClinicalTrials.gov

Summary

This is a prospective, single-arm, open-label, pilot clinical study to evaluate the efficacy and safety of nasopharyngeal administration of 13.6% high-concentration 35 kDa hyaluronan (HA35) care gel in subjects with chronic rhinitis and chronic pharyngitis. Eligible participants will receive the study gel twice daily for 10 consecutive days. The primary objectives are to assess rapid changes in nasopharyngeal discomfort, posterior pharyngeal discomfort, and nasal obstruction within 30 minutes after the first administration. Secondary objectives include evaluation of overall symptom improvement at day 10, changes in subjective mental clarity, and safety and tolerability throughout the treatment period. This is a minimal-risk, non-pharmacological supportive care intervention.

Official title: A Prospective, Single-Arm, Open-Label Pilot Clinical Study to Evaluate Efficacy and Safety of Topical 10% 35 kDa Hyaluronan (HA35) Gel for Ultra-Rapid Relief of Skin Pruritus

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-05-01

Completion Date

2026-07-01

Last Updated

2026-09-23

Healthy Volunteers

No

Interventions

DEVICE

13.6% High-Concentration 35 kDa Hyaluronan (HA35) Nasopharyngeal Care Gel

A topical, non-pharmacological nasopharyngeal care gel containing 13.6% high-concentration 35 kDa hyaluronan. It is designed to support mucosal hydration and reduce inflammation in the nasopharynx. Administration is via direct nasopharyngeal application, twice daily for 10 consecutive days.

Locations (1)

Qingdao Hynaut Laboratory

Qingdao, Shandong, China