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

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Brief Title

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

Official Title

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

Brief Summary

      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.
    

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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

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.

Secondary Outcome

 Change in the duration of the lesions with two different dose regimes of Dentoxol® mouthrinse and compare both effects.

Condition

Epidermolysis Bullosa

Intervention

Dentoxol mouthrinse dosages

Study Arms / Comparison Groups

 Group A
Description:  First 6 weeks they will use the mouthrinse 5 times a day, following 4 week washout period.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Combination Product

Estimated Enrollment

100

Start Date

April 6, 2022

Completion Date

March 2023

Primary Completion Date

August 2022

Eligibility Criteria

        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.
      

Gender

All

Ages

6 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Susanne Kramer, MsC, , 

Location Countries

Chile

Location Countries

Chile

Administrative Informations


NCT ID

NCT05288478

Organization ID

PRI-ODO 2021/16


Responsible Party

Principal Investigator

Study Sponsor

University of Chile

Collaborators

 Fundación Debra Chile

Study Sponsor

Susanne Kramer, MsC, Principal Investigator, University of Chile


Verification Date

April 2022