By InvitationPhase 1/2

Hyaluronic Acid in the Treatment of Hyposalivation

Poland100 participantsStarted 2025-07-01

Plain-language 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.

Who can participate

Age range

38 Years – 78 Years

Sex

ALL

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: * subjective feeling of dry mouth caused by a lack of saliva for at least 3 month, * informed consent sing by patient, * other complains including difficulty during eating, speaking or swallowing, taste disorders, trouble wearing dentures, the sensation that the tongue is stuck to the palate, bad breath and insomnia, feeling dry mouth at night, which made it difficult or impossible to sleep. Exclusion Criteria: * smoking, * alkohol drinking, * pregnancy, * breast feeding, * diabetes, * immunosuppressive treatment, * neoplastic diseases, * Sjögren disease, * active inflammation in the oral cavity, * participation in other clinical trial in within the last 3 months, * allergy or hipersensitivity to hyaluronic acid or amino acides, * no planned hospital stay during the study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient-reported pain connected with oral dryness using Visual Analog Scale (VAS)

Timeframe: Baseline

Patient-reported pain connected with oral dryness using Visual Analog Scale (VAS)

Timeframe: 8 weeks following the baseline

Improvement in patients-reported oral dryness score using an auctorial questioner

Timeframe: Baseline

Improvement in patients-reported oral dryness score using an auctorial questioner

Timeframe: 8 weeks following the baseline.

Trial details

NCT IDNCT07309588

SponsorPoznan University of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-19

View on ClinicalTrials.gov More Xerostomia Due to Hyposecretion of Salivary Gland trials

Plain-language summary

Who can participate

Age range

38 Years – 78 Years

Sex

ALL

See this in plain English?

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

What they're measuring

Patient-reported pain connected with oral dryness using Visual Analog Scale (VAS)

Timeframe: Baseline

Patient-reported pain connected with oral dryness using Visual Analog Scale (VAS)

Timeframe: 8 weeks following the baseline

Improvement in patients-reported oral dryness score using an auctorial questioner

Timeframe: Baseline

Improvement in patients-reported oral dryness score using an auctorial questioner

Timeframe: 8 weeks following the baseline.