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

University of Chile

Status and phase: Unknown; Phase 2

Conditions: Oral Ulcer; Epidermolysis Bullosa

Treatments: Combination Product: Dentoxol mouthrinse dosages

Study type: Interventional

Funder types: Other

Identifiers

NCT05288478

PRI-ODO 2021/16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

100 participants in 4 patient groups

Group A

Active Comparator group

Description:

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

Treatment:

Combination Product: Dentoxol mouthrinse dosages

Group A, second period

Active Comparator group

Description:

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.

Treatment:

Combination Product: Dentoxol mouthrinse dosages

Group B

Active Comparator group

Description:

First 6 weeks they will use the mouthrinse twice a day, following 4 week washout period

Treatment:

Combination Product: Dentoxol mouthrinse dosages

Group B, second period

Active Comparator group

Description:

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.

Treatment:

Combination Product: Dentoxol mouthrinse dosages