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Hyaluronic Acid in the Treatment of Hyposalivation

NCT07309588 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-12-30

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if drug containing non-crosslinked hyaluronic acid and amino acids solution (Sunecos-200) works to treat hyposalivation in adults. It will also learn about the safety of drug Sunecos-200. The main questions it aims to answer are:

* Does Sunecos-200 improve the saliva secretion and improve a life comfort?
* What medical problems do participants have when taking Sunecos-200? Researchers will compare drug containing non-crosslinked hyaluronic acid and amino acids solution (Sunecos-200) to a control group (without intervention) to see if drug Sunecos-200 works to treat hyposalivation.

Participants will:

* Take drug Sunecos-200 by into oral mucosa injection or nothing every two weeks for 4 times.
* Visit the clinic once every 2 weeks for checkups and tests
* Keep a diary of their symptoms after injection and fill out a primary and final questionary.

Conditions

  • Xerostomia Due to Hyposecretion of Salivary Gland

Interventions

COMBINATION_PRODUCT

Sunecos-200 Injectable Hyaluronic acid and amino acids solution

In the study group with intervention a total of 2 mL (1 mL on each side) of Sunecos-200 solution (HA and AAs) were injected into the buccal mucosa four times at two-week intervals. The distance between the points of the injections was approximately 10 mm. The total number of injection points per side was 5. Cosmetic syringes (1 ml) and needles 30 G 4 mm were used for injection.

Sponsors & Collaborators

  • Poznan University of Medical Sciences

    lead OTHER

Principal Investigators

  • Marzena Liliana Wyganowska, Professor · Poznan University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
38 Years
Max Age
78 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2025-12-19
Completion
2026-01-19

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07309588 on ClinicalTrials.gov