Dose-ranging Study of Dentoxol® Mouthrinse for Managing Oral Symptoms in People With Epidermolysis Bullosa.

April 6, 2022 updated by: Susanne Kramer, University of Chile

Phase II Dose-ranging Study of Dentoxol® Mouthrinse for Managing Oral Symptoms in Epidermolysis Bullosa.

Inherited Epidermolysis Bullosa (EB) is a disorder that causes skin fragility and blistering in skin and mucous membranes, including the mouth. Recurrent oral blisters and ulcer result in oral pain and discomfort.

Dentoxol® is a mouthrinse that has anti-inflammatory, antimicrobial and analgesic effects. It has significant potential to reduce EB related oral symptoms.

This study includes people living with Inherited Epidermolysis Bullosa aged 6 and above; and is aimed at determining the efficacy of two different dose regimens of Dentoxol mouthrinse in reducing oral symptoms.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Inherited Epidermolysis Bullosa (EB) is a group of genetic disorders with skin fragility and blistering. In addition to the skin, it can affect the mucous membranes, causing oral symptoms including oral pain and discomfort due to recurrent oral blisters, ulcers and erosions. Dentoxol® is a proprietary mouthrinse that has anti-inflammatory, antimicrobial and analgesic effects. This three-pronged strategy therefore has significant potential to reduce EB related oral symptoms.

Preliminary reports of Dentoxol® mouthrinse have suggested that it is safe and effective in reducing the EB related oral symptoms.Therefore, a well-controlled Phase II study is now warranted.

This study will include people living with Inherited Epidermolysis Bullosa aged 6 and over, and seeks to determinate the efficacy of two different dose regimens of Dentoxol mouthrinse in reducing the symptoms mentioned above.

Methods: 100 subjects with EB will be recruited and will be given Dentoxol® mouthrinse for two periods of 6 weeks using different dose regimes.

Subjects will have a dose regimen assigned randomly, group A: first 6 weeks will be asked to rinse 5 times a day, followed by a 4 weeks washout period and the second 6 weeks period: twice a day. Group B: first 6 weeks 2 times a day, second 6 weeks period: 5 times a day, both with a 4 week washout period in between.

On week 0, 1, 3 and 6 of each regime patients living in the metropolitan area will be examined by the Oral Medicine specialist.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile, 8380491
        • Facultad de Odontología, Universidad de Chile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • People living with Inherited Epidermolysis Bullosa, including all types and subtypes, registered at Debra Foundation at the country of the study.

Exclusion Criteria:

  • Unable to give written informed consent / assent.
  • Have used a mouth rinse aimed at managing oral ulcers in the last 4 weeks.
  • Known allergy/intolerance to any component of the study rinse.
  • Planning to use any of the following contraindicated medications during the study period (pain medications are allowed)
  • Any agent marketed for oral mucositis
  • Steroids
  • Antibiotics (eg, tetracyclines) (Note: topical antifungals are allowed)
  • Povidone iodine
  • Sucralfate and other coating agents such as Gelclair, MuGard, etc.
  • Caphosol
  • Chlorhexidine Gluconate (Oralgene, Perioaid, Peridex, Periogard)
  • Diphenhydramine (Benadryl)
  • Laser therapy for oral mucositis
  • Any other anti-inflammatory agent
  • Any other investigative agent
  • *Note: "Miracle / Magic" rinse preparations containing viscous lidocaine are allowed, however, diphenhydramine and other excluded agents should not be added.
  • Age below 6 years
  • Pregnant or nursing
  • Unable to rinse the mouth due to limited oral functioning.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
First 6 weeks they will use the mouthrinse 5 times a day, following 4 week washout period.
Combination product: Dentoxol mouthrinse dosages
Subjects will have a dose regimen assigned randomly, group A: first 6 weeks 5 times a day, following 6 weeks twice a day, and group B: first 6 weeks 2 times a day following 6 weeks 5 times a day, both with a 4 week washout period in between.
Active Comparator: Group A, second period

After the washout period, the next 6 weeks the will use the mouthrinse twice a day.

On week 0, 1, 3 and 6 of each regime patients living in the metropolitan area will be examined by the Oral Medicine specialist.
Combination product: Dentoxol mouthrinse dosages
Subjects will have a dose regimen assigned randomly, group A: first 6 weeks 5 times a day, following 6 weeks twice a day, and group B: first 6 weeks 2 times a day following 6 weeks 5 times a day, both with a 4 week washout period in between.
Active Comparator: Group B
First 6 weeks they will use the mouthrinse twice a day, following 4 week washout period
Combination product: Dentoxol mouthrinse dosages
Subjects will have a dose regimen assigned randomly, group A: first 6 weeks 5 times a day, following 6 weeks twice a day, and group B: first 6 weeks 2 times a day following 6 weeks 5 times a day, both with a 4 week washout period in between.
Active Comparator: Group B, second period

After the washout period, the next 6 weeks they will use the mouthrinse 5 times a day.

On week 0, 1, 3 and 6 of each regime patients living in the metropolitan area will be examined by the Oral Medicine specialist.
Combination product: Dentoxol mouthrinse dosages
Subjects will have a dose regimen assigned randomly, group A: first 6 weeks 5 times a day, following 6 weeks twice a day, and group B: first 6 weeks 2 times a day following 6 weeks 5 times a day, both with a 4 week washout period in between.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in oral symptoms associated to oral bullae, erosions and ulcerations in adults and children over the age of 6 living with Epidermolysis Bullosa with two different dose regimes of Dentoxol® mouthrinse and compare both effects.
Time Frame: 16 weeks
Epidermolysis Bullosa Oral Health Questionnaire (EBOHQ)
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the duration of the lesions with two different dose regimes of Dentoxol® mouthrinse and compare both effects.
Time Frame: 16 weeks
Epidermolysis Bullosa Oral Health Questionnaire (EBOHQ) (Validated Questionnaire)
16 weeks
Change in the frequency of the lesions with two different dose regimes of Dentoxol® mouthrinse and compare both effects.
Time Frame: 16 weeks
Epidermolysis Bullosa Oral Health Questionnaire (EBOHQ) (Validated Questionnaire)
16 weeks
Change in the recurrence of the lesions with two different dose regimes of Dentoxol® mouthrinse and compare both effects.
Time Frame: 16 weeks
Epidermolysis Bullosa Oral Health Questionnaire (EBOHQ) (Validated Questionnaire)
16 weeks
Change in the size of the lesions with two different dose regimes of Dentoxol® mouthrinse and compare both effects.
Time Frame: 16 weeks
Epidermolysis Bullosa Oral Health Questionnaire (EBOHQ) (Validated Questionnaire)
16 weeks
Change in the number of the lesions with two different dose regimes of Dentoxol® mouthrinse and compare both effects.
Time Frame: 16 weeks
Epidermolysis Bullosa Oral Health Questionnaire (EBOHQ) (Validated Questionnaire)
16 weeks
Change in the distribution of the lesions with two different dose regimes of Dentoxol® mouthrinse and compare both effects.
Time Frame: 16 weeks
Epidermolysis Bullosa Oral Health Questionnaire (EBOHQ) (Validated Questionnaire)
16 weeks
Change in oral pain with two different dose regimes of Dentoxol® mouthrinse and compare both effects.
Time Frame: 16 weeks
Epidermolysis Bullosa Oral Health Questionnaire (EBOHQ) (Validated Questionnaire)
16 weeks
Improve the oral health related quality of life and oral functioning with two different dose regimes of Dentoxol® mouthrinse and compare both effects.
Time Frame: 16 weeks
Epidermolysis Bullosa Oral Health Questionnaire (EBOHQ) (Validated Questionnaire)
16 weeks
Patients compliance with treatment.
Time Frame: 16 weeks
Daily record of mouthrinse use.
16 weeks
Patients acceptance of mouthrinse use
Time Frame: 16 weeks
Mouthrinse Acceptance Form (Validated Questionnaire)
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chile

Collaborators

Fundación Debra Chile

Investigators

  • Principal Investigator: Susanne Kramer, MsC, University of Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2022

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

November 24, 2021

First Submitted That Met QC Criteria

March 10, 2022

First Posted (Actual)

March 21, 2022

Study Record Updates

Last Update Posted (Actual)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRI-ODO 2021/16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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