NCT04206826

Tolerance and Efficiency of an Intrabuccal Biological Film to Enhance Oral Dryness Sensation: The "PREDELFI" Clinical Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Xerostomia affects at least a quarter of the population. This prevalence is increased in postmenopausal women and people over 65 years of age. Associated with age are systemic diseases such as Sjögren's Syndrome, diabetes, Parkinson's disease or cancer. It handicaps the patient in his social life, but also in terms of his well-being by the consequences it generates in the oral cavity. This dryness may be the consequence of taking certain medications, head and neck radiotherapy, but also being a symptom of an underlying pathology whose screening will allow early treatment and avoid complications. Today, no single therapeutic solution is enough and patients are waiting for new therapeutic innovations in this area. This study proposes to evaluate the tolerance of an adhesive film containing prebiotics by comparing it to a placebo control film.

Detailed description

The purpose of this study is to evaluate the tolerance of an adhesive film containing prebiotics on the improvement of signs and symptoms related to dry mouth by comparing it to a placebo film. The primary endpoint is the assessment of tolerability assessed using a visual analogue scale (VAS) from 0 to 100 at the end of the 1-month period of both treatment periods (D30 and D90). In this study, the efficacy and tolerance of the adhesive film containing prebiotics will be analyzed. Each participant in this study will receive two galenic forms of the medical device whose allocation order was previously defined by a randomization list.

Conditions

• Sicca Syndrome
• Xerostomia

Interventions

Type	Name	Description
DEVICE	PREDELFI	It's a natural film which contains a concentrated alpha-GOS (alpha-galacto-oligosaccharide) soy extract, a milk protein concentrate containing caseins and whey proteins and vegetable glycerin
DEVICE	CONTROL	It's a natural film which is devoided of active ingredient. It contains sodium alginate; vegetable glycerin, caramel, beta carotene and water.

Timeline

• Start date: 2020-06-25
• Primary completion: 2021-04-23
• Completion: 2021-04-23
• First posted: 2019-12-20
• Last updated: 2025-02-05

Locations

1 site across 1 country: France