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NCT04206826 | COMPLETED | Sicca Syndrome

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

University Hospital, Brest

Brief 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.

Condition or disease

Sicca Syndrome

Xerostomia

Intervention/treatment

PREDELFI

CONTROL

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 10 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : Tolerance and Efficiency of an Intrabuccal Biological Film to Enhance Oral Dryness Sensation: The "PREDELFI" Clinical Pilot Study
Actual Study Start Date : 2020-06-25
Estimated Primary Completion Date : 2021-04-23
Estimated Study Completion Date : 2021-04-23

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Men or women aged 18 or over
  • * Complaining of xerostomia and validated by a standardized question
  • * With hyposialia diagnosed by the measurement of stimulated salivary flow (DSS) and unstimulated (DNS)
  • * Patient having signed a consent
  • * Registered with Social Security
Exclusion Criteria
  • * The patient having known sensitivity to any of the products or components of the biofilms (milk protein, soy derivatives, sodium alginate, vegetable glycerin, caramel and beta carotene)
  • * Allergic to birch and / or peanut
  • * Having an ethyl intoxication (\> 2 glasses of wine / day), smoking (\> 10 cigarettes / day)
  • * Unable to complete self-assessment questionnaires or to follow study protocol procedures (unable to read and / or write).
  • * Participant in another clinical study at the time of inclusion or having participated in the 30 days preceding recruitment in this study
  • * Having a life-threatening condition for the duration of the study
  • * Treated with sialogogues (pilocarpine hydrochloride) within 30 days prior to inclusion
  • * Using salivary substitutes
  • * Protected persons within the law (articles L1121-5 to L1121-8)
Tolerance and Efficiency of an Intrabuccal Biological Film to Enhance Oral Dryness Sensation: The "PREDELFI" Clinical Pilot Study

Location Details

NCT04206826

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How to Participate

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Locations

Not yet recruiting

France,

Chru Brest

Brest, France, 29609