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

NCT05288478 | Unknown Phase 2

• 1 other identifier: PRI-ODO 2021/16
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Epidermolysis Bullosa; Oral Ulcer

Keywords

Epidermolysis Bullosa; Oral ulcer; Oral blisters; Dentoxol mouthrinse

Outcome Measures

Primary Outcomes (1)

• 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.

  Epidermolysis Bullosa Oral Health Questionnaire (EBOHQ)

  16 weeks

Secondary Outcomes (10)

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

  16 weeks

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

  16 weeks

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

  16 weeks

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

  16 weeks

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

  16 weeks

Study Arms (4)

Group A

ACTIVE COMPARATOR

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

Combination Product: Dentoxol mouthrinse dosages

Group A, second period

ACTIVE COMPARATOR

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

Group B

ACTIVE COMPARATOR

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

Combination Product: Dentoxol mouthrinse dosages

Group B, second period

ACTIVE COMPARATOR

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

Interventions

Dentoxol mouthrinse dosages COMBINATION_PRODUCT

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.

Group A; Group A, second period; Group B; Group B, second period

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chile: lead
• Fundación DEBRA Chile, Niños Piel de Cristal: collaborator

Study Sites (1)

Facultad de Odontología, Universidad de Chile

Santiago, Santiago Metropolitan, 8380491, Chile

Location

Related Publications (20)

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• Has C, Liu L, Bolling MC, Charlesworth AV, El Hachem M, Escamez MJ, Fuentes I, Buchel S, Hiremagalore R, Pohla-Gubo G, van den Akker PC, Wertheim-Tysarowska K, Zambruno G. Clinical practice guidelines for laboratory diagnosis of epidermolysis bullosa. Br J Dermatol. 2020 Mar;182(3):574-592. doi: 10.1111/bjd.18128. Epub 2019 Aug 9.

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• Sindici E, Astesano S, Fazio L, Dragonetti A, Pugliese M, Scully C, Carossa S, Broccoletti R, Arduino PG. Treatment of Oral Lesions in Dystrophic Epidermolysis Bullosa: A Case Series of Cord Blood Platelet Gel and Low-level Laser Therapy. Acta Derm Venereol. 2017 Mar 10;97(3):383-384. doi: 10.2340/00015555-2512. No abstract available.

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• Kramer S, Lucas J, Gamboa F, Penarrocha Diago M, Penarrocha Oltra D, Guzman-Letelier M, Paul S, Molina G, Sepulveda L, Araya I, Soto R, Arriagada C, Lucky AW, Mellerio JE, Cornwall R, Alsayer F, Schilke R, Antal MA, Castrillon F, Paredes C, Serrano MC, Clark V. Clinical practice guidelines: Oral health care for children and adults living with epidermolysis bullosa. Spec Care Dentist. 2020 Nov;40 Suppl 1(Suppl 1):3-81. doi: 10.1111/scd.12511.

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• Rojas P, Kramer S, Veliz S, Seguel M, Alsayer F, Sepulveda L. Dentoxol Mouthwash for People With Epidermolysis Bullosa: A Qualitative Study of Self-Perceived Symptoms and Quality of Life. Spec Care Dentist. 2025 Mar-Apr;45(2):e70036. doi: 10.1111/scd.70036.

  PMID: 40268883 DERIVED

MeSH Terms

Conditions

Epidermolysis Bullosa; Oral Ulcer

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vesiculobullous; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Susanne Kramer, MsC

  University of Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 100 subjects with EB will be recruited, divided into groups according to their mayor type of EB and subtype, they will use Dentoxol® mouthrinse twice a day or 5 times each day. 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. 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 Record Dates

• First Submitted: November 24, 2021
• First Posted: March 21, 2022
• Study Start: April 6, 2022
• Primary Completion: August 1, 2022
• Study Completion: March 1, 2023
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

CL (1)