Status:
UNKNOWN
Dose-ranging Study of Dentoxol® Mouthrinse for Managing Oral Symptoms in People With Epidermolysis Bullosa.
Lead Sponsor:
University of Chile
Collaborating Sponsors:
Fundación DEBRA Chile, Niños Piel de Cristal
Conditions:
Epidermolysis Bullosa
Oral Ulcer
Eligibility:
All Genders
6+ years
Phase:
PHASE2
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 an...
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 or...
Eligibility Criteria
Inclusion
- People living with Inherited Epidermolysis Bullosa, including all types and subtypes, registered at Debra Foundation at the country of the study.
Exclusion
- 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.
Key Trial Info
Start Date :
April 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05288478
Start Date
April 6 2022
End Date
March 1 2023
Last Update
April 14 2022
Active Locations (1)
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1
Facultad de Odontología, Universidad de Chile
Santiago, Santiago Metropolitan, Chile, 8380491