Hyaluronic Acid in the Treatment of Hyposalivation

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Patient-reported pain connected with oral dryness using Visual Analog Scale (VAS) — Baseline
  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.
• Patient-reported pain connected with oral dryness using Visual Analog Scale (VAS) — 8 weeks following the baseline
  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.
• Improvement in patients-reported oral dryness score using an auctorial questioner — Baseline
  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.
• Improvement in patients-reported oral dryness score using an auctorial questioner — 8 weeks following the baseline.
  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.

Trial sites (1)

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