Hyaluronic Acid in the Treatment of Hyposalivation

NCT07309588 | Enrolling By Invitation Phase 1

• 1 other identifier: PUMS-Hyposalivation-2025-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

hyaluronic acid; amino acids; dry mouth

Outcome Measures

Primary Outcomes (4)

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

  The Visual Analogue Scale (VAS) assess the pain intensity on a scale from 0 to 10, where 0 indicates no pain; 1-3 - indicates mild pain; 4-6 - indicates moderate pain; 7-9 - indicates severe pain; and 10 - indicates unbearable pain.

  Baseline

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

  The Visual Analogue Scale (VAS) assess the pain intensity on a scale from 0 to 10, where 0 indicates no pain; 1-3 - indicates mild pain; 4-6 - indicates moderate pain; 7-9 - indicates severe pain; and 10 - indicates unbearable pain.

  8 weeks following the baseline

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

  The auctorial questioner conteins 10 questions based on Xerostomia Inventory test. The 5 stages Likert scale is used for answer: 1-never, 2-rarely, 3-sometimes, 4-often, 5-always. The score 11-20 means mild dryness; 21-35 means moderate dryness; 36-50 severe dryness. The change of 5 points or more in the score is considered a clinically significant outcome, indicatig the success of treatment.

  Baseline

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

  The auctorial questioner conteins 10 questions based on Xerostomia Inventory test. The 5 stages Likert scale is used for answer: 1-never, 2-rarely, 3-sometimes, 4-often, 5-always. The score 11-20 means mild dryness; 21-35 means moderate dryness; 36-50 severe dryness. The change of 5 points or more in the score is considered a clinically significant outcome, indicatig the success of treatment.

  8 weeks following the baseline.

Secondary Outcomes (10)

• Changes in unstimulated saliva before HA and AAs injections - mirror test

  Baseline

• Changes in unstimulated saliva after HA and AAs injections - mirror test.

  8 weeks following the baseline

• Consistency changes in unstimulated saliva before HA and AAs injections.

  Baseline

• Consistency changes in unstimulated saliva after HA and AAs injections.

  8 weeks following the baseline

• pH changes in unstimulated saliva before HA and AAs injections.

  Baseline

Study Arms (2)

Study group with intervention of Sunecos-200; injectable HA and AA solution

EXPERIMENTAL

50 patients (age 38-78) with hyposalivation and syptoms of dry mouth were randomly selected, and the treatment protocol was applied. Exclusion criteria: smoking, pregnancy, breast feeding, diabetes, immunosuppressive treatment and neoplastic diseases. Sjögren disease and active inflammation in the oral cavity were also ruled out. In the study group Sunecos-200; HA and AAs solution were used as an intervention four times in 2 weeks intervals. At the beginning (qualification visit) and the end of study (2 weeks after the last intervention) the patients completed auctorial questionnaire. The pain level was measured with VAS scale. Patients also completed ( on the qualification and final visit) intraoral examination, including a "mirror test" to evaluate unstimulated saliva flow. To evaluate both unstimulated and stimulated saliva characteristic, a Saliva-Check Buffer GC test kit was used. Patients were asked to not change hygienic protocol and not use a saliva stimulants.

Combination Product: Sunecos-200 Injectable Hyaluronic acid and amino acids solution

Control group without intervention

NO INTERVENTION

50 patients (age 38-78) with hyposalivation and syptoms of dry mouth were randomly selected as a control group. Exclusion criteria: smoking, pregnancy, breast feeding, diabetes, immunosuppressive treatment and neoplastic diseases. Sjögren disease and active inflammation in the oral cavity were also ruled out.At the beginning (qualification visit) and the end of study (2 weeks after the last intervention in study group with intervention) the patients completed auctorial questionnaire. The pain level was measured with VAS scale. Patients also completed (on the qualification and final visit) intraoral examination, including a "mirror test" to evaluate unstimulated saliva flow. To evaluate both unstimulated and stimulated saliva characteristic, a Saliva-Check Buffer GC test kit was used. Patients were asked to not change hygienic protocol and discontinue the use of saliva stimulants.

Interventions

Sunecos-200 Injectable Hyaluronic acid and amino acids solution COMBINATION_PRODUCT

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.

Study group with intervention of Sunecos-200; injectable HA and AA solution

Eligibility Criteria

• Age: 38 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Department of Periodontology and Oral Mucosa Diseases, Poznan University of Medical Sciences

Poznan, Greater Poland Voivodeship, 60-812, Poland

Location

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Marzena Liliana Wyganowska, Professor

  Poznan University of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: no masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical investigation for new indication of medical device. In this protocol the investigators use medical device class III, not a registerd drug. Study Model: Interventional, Open-label, Controlled

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 30, 2025
• Study Start: July 1, 2025
• Primary Completion: December 19, 2025
• Study Completion: January 19, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 month after publication of the main resultsand ending 5 years thereafter.
• Access Criteria: Data will shared with researchers who provide a methodically sound proposal approved by the study sponsor. Request should be directed to wyganowska@ump.edu.pl or sklewinsteinbock@ump.edu.pl

Locations

PL (1)