Efficacy of Slow Release Clotrimazole Varnish Treating De... | NCT00835029

Studies
Efficacy of Slow Release Clotrimazole Varnish Treating Denture Stomatitis Comparing to Traditional Treatment of Troches

NCT00835029

Sponsor

Hadassah Medical Organization

Status

Completed

Last Update Posted

Mar 25, 2015Estimated

Enrollment

13Actual

Phase

Phase 2

Conditions

Oral Candidiasis
Denture Stomatitis

Interventions

Clotrimazole varnish
Clotrimazole troches

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Feb 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

Feb 1, 2009

First Submission Date that Met QC Criteria

Feb 2, 2009

First Posted Date

Feb 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2015

Last Update Posted Date

Mar 25, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Czerninski Rakefet, Dr, Oral diseases clinic, Hadassah Medical OrganizationPrincipal Investigator

Lead Sponsor

Hadassah Medical OrganizationOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Background: Oral candidiasis is most frequently found among the elderly .It is accompanied with oral pain, irritation, burning sensation. In addition, the altered taste sensation may cause nutrition compromise, which may affect ones diet. Management of superficial oral Candida is usually achieved by treatment with clotrimazole, a fungi static drug which is given five times per day with instruction to slowly suck on it with out the dentures.

Working hypothesis and aims: Management of oral candidiasis is feasible. The major disadvantage of the mode of action now days is the substantively of the drug in the oral cavity and patient compliance. A sustained release varnish which is easily applied on the dentures, which also release the anti fungal drug for at least a day, may overcome some of the pit falls of the treatment applied today.

Based on our past experience, in developing local sustained release varnishes for dental use, we anticipate that we can also formulate a special anti fungal sustained release varnish which will fit the special and unique needs of the elderly population.

Methods: Sustained release varnish will be developed in our laboratory. The kinetics of release (using HPLC) and antifungal activity (Bioassays) will be examined in vitro. The formulation showing the optimal results will be tested on human subjects with oral candidiasis. The efficacy of the varnish will be examined clinically (reduction in symptoms), microbiology (reduction of oral fungal), pharmaceutically (release kinetics in vivo).

Expected results: The clinical out come of one time varnish application will be improved compared to the five times application of lozenges (used today). The severity of the disease should decrease and the healing period should be shorten drastically.

Importance: This is a novel pharmaceutical development of a local application of a dental varnish designed specially to the elderly population

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Clotrimazole varnish	Active Comparator	Clotrimazole in a slow release varnish treatment	Drug: Clotrimazole varnish
Clotrimazole troches	Active Comparator	Clotrimazole troches 10 mgx5 day for treatment of denture associated candiad infection	Drug: Clotrimazole troches

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clotrimazole varnish	Drug	Each patient will receive 14 syringes (with no needle, equivalent to 50 mg of Clotrimazole in each one) . The varnish will be applied on a dried denture at the inner side by means of a soft brush and left to dry for 60 sec for 14 days.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Microbial evidence of reduced candida infection		one and two weeks after inevention

Secondary Outcomes

Measure	Description	Time Frame
Clinical evidence for candida infection		One and two weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adults
removable denture in mouth
diagnosed oral candida

Exclusion Criteria:

allergy to clotrimazole
immunosuppressed
using other antifungi treatment
have an active oral ulcerative disease
impaired kidny or live functions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rakefet Czerninski, DMD	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hdassah medical Organization,		Jerusalem			Israel

Condition Browse Module

MeSH Terms

ID	Term
D002180	Candidiasis, Oral
D013282	Stomatitis, Denture
C536972	Torulopsis

Ancestor Terms

ID	Term
D002177	Candidiasis
D009181	Mycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

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Browse Branches

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