Clinical Studies

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Clinical Evaluation of the Efficacy of “Hyaluronan” Formulation for dry mouth in patients with Type 2 diabetes.

Xerostomia (dry mouth) has been reported to be a common complaint of patients with diabetes, Without adequate saliva production, both hard and soft tissues of the mouth can be severely damaged and become more susceptible to infections. An IRB approved, double blind, cross over, placebo controlled study was conducted in the Division of Endocrinology and Metabolism, Saint Louis University. In this study it was tested a novel Hyaluronic Acid solution for treatment of dry mouth and its tolerability in type 2 diabetes patients with symptomatic oral dryness. The data obtained from the just concluded study is being analyzed.

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Clinical Evaluation of the efficacy of an intra oral spray on speech production in patients using Invisalign.

One common concern of those undergoing invisalign treatment, is the development of speech impairment upon invisalign tray delivery. There is a need for an oral care product to make these patients more comfortable. In this study, we propose to test a novel mouth lubrication solution for the improvement of articulation problem during invisalign treatment. This 21 day randomized, single center, crossover study is being done at School of Orthodontics, Brooks Rehabilitation College of Healthcare Sciences, Jacksonville University.

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Clinical Evaluation of the Efficacy of Hyalouran Formulation for Vaginal Dryness and irritation

Estrogen levels decline during the menopause transition and after menopause. One of the consequences of this normal decline in estrogen is vaginal atrophy, which in many women causes symptoms of dryness, lack of lubrication and dyspareunia. The IRB approved double blind, placebo controlled crossover study at University at Buffalo will test a novel lubricating solution for treatment and tolerability in women with symptomatic vaginal dryness.

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CLINICAL EVALUATION OF THE EFFICACY OF HYALURONAN FORMULATION FOR DRY MOUTH WITH SLEEP APNEA PATIENTS

This cross-over group, randomized, single center, study will enroll subjects to evaluate the safety and efficacy of an HA formulation in people suffering from dry mouth due to CPAP therapy. Subjects from the sleep clinic of Veterans Affairs Medical Center in Buffalo, NY will be recruited under the IRB approved study. Patients will be included in this study when one or more of the symptoms of dry mouth of moderate to severe nature is present.  The duration of the study is 9 weeks and at the end of each treatment day, week and study, the participants will be asked to answer survey questions pertaining to the use of the test sprays. Adverse experiences will be noted and recorded during the study. Study is ongoing and enrollment is open.

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Efficiency of Hyaluronan ”Formulation” for dry skin relief.

Individuals with dry skin experience itching because the sensory nerves in the lower layer of the skin are directly subjected to the external stimuli by the collapsing skin barrier function. If one is prone to develop atopic dermatitis, excessive dryness can lead to activation of the disease, causing redness, cracking and inflammation. Dry skin may crack, allowing bacteria to enter, causing infections. Dry skin decreases a person’s quality of life because of the discomfort associated with tight and dry skin. The IRB approved randomized study will investigate the tolerability of a novel lubricating solution in patients with symptomatic skin dryness and its efficacy in minimizing the symptoms associated with dry skin. The objectives of this study are to evaluate patients’ perception of efficacy of a dry skin spray containing Hyaluronic Acid, compared to a placebo in reducing dry skin and atopic dermatitis.

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DETERMINATION OF THE SAFETY AND EFFECTIVENESS OF AN ORAL RINSE IN THE REDUCTION OF MEDICATION-ASSOCIATED METALLIC TASTE

The primary intent of this ongoing study is to determine the effectiveness of the oral rinse in reducing the metallic taste in the mouth associated with various reasons, including chemotherapeutic agents. This is a randomized, double-blind, parallel design study with a placebo as the control. The duration of the study will be 1 month. Oral examinations will be done during the study visits. Also at these visits, subjects will be asked about their relief obtained from the medication-associated metallic taste in their mouth and the degree of relief of metallic taste. They will also be asked about the taste and consistency of the mouth rinse. Gingival health will be measured using the Modified Gingival Index (MGI). Safety of the study drug will be monitored through oral soft tissue examinations, including an evaluation of gingival health, tooth and restoration surfaces, and adverse event reporting. The primary response variable will be the relief from medication-associated metallic taste. Study enrollment is open.