Epidermolysis BullosaPhase 2NCT05288478
Dose-ranging Study of Dentoxol® Mouthrinse for Managing Oral Symptoms in People With Epidermolysis Bullosa.
A Phase 2 study testing Dentoxol mouthrinse dosages in people with Epidermolysis Bullosa and Oral Ulcer, run by University of Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Epidermolysis Bullosa, Oral Ulcer
- What is being tested?
- Dentoxol mouthrinse dosages
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChile
- Study dates
- 6 Apr 2022to Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- People living with Inherited Epidermolysis Bullosa, including all types and subtypes, registered at Debra Foundation at the country of the study.
Who cannot join
- 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
Show all 19Show fewer
- 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 locations and contacts
1 site in 1 country.
Chile1 site
Facultad de Odontología, Universidad de Chile
Santiago, Santiago Metropolitan, 8380491
About this study
Official title: 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.
Read the 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.
- Conditions
- Epidermolysis Bullosa, Oral Ulcer
- Being tested
- Dentoxol mouthrinse dosages
- Keywords
- Epidermolysis Bullosa, Oral ulcer, Oral blisters, Dentoxol mouthrinse
- Medical subject headings
- Epidermolysis Bullosa, Oral Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dentoxol mouthrinse dosagesCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | First 6 weeks they will use the mouthrinse 5 times a day, following 4 week washout period. Receives: 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. Receives: 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 Receives: 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. Receives: Combination Product: Dentoxol mouthrinse dosages |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 16 weeks
Secondary outcomes (10)
Change in the duration of the lesions with two different dose regimes of Dentoxol® mouthrinse and compare both effects.
Epidermolysis Bullosa Oral Health Questionnaire (EBOHQ) (Validated Questionnaire)
Measured: 16 weeks
Change in the frequency of the lesions with two different dose regimes of Dentoxol® mouthrinse and compare both effects.
Epidermolysis Bullosa Oral Health Questionnaire (EBOHQ) (Validated Questionnaire)
Measured: 16 weeks
Change in the recurrence of the lesions with two different dose regimes of Dentoxol® mouthrinse and compare both effects.
Epidermolysis Bullosa Oral Health Questionnaire (EBOHQ) (Validated Questionnaire)
Measured: 16 weeks
Change in the size of the lesions with two different dose regimes of Dentoxol® mouthrinse and compare both effects.
Epidermolysis Bullosa Oral Health Questionnaire (EBOHQ) (Validated Questionnaire)
Measured: 16 weeks
Change in the number of the lesions with two different dose regimes of Dentoxol® mouthrinse and compare both effects.
Epidermolysis Bullosa Oral Health Questionnaire (EBOHQ) (Validated Questionnaire)
Measured: 16 weeks
Change in the distribution of the lesions with two different dose regimes of Dentoxol® mouthrinse and compare both effects.
Epidermolysis Bullosa Oral Health Questionnaire (EBOHQ) (Validated Questionnaire)
Measured: 16 weeks
Change in oral pain with two different dose regimes of Dentoxol® mouthrinse and compare both effects.
Epidermolysis Bullosa Oral Health Questionnaire (EBOHQ) (Validated Questionnaire)
Measured: 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.
Epidermolysis Bullosa Oral Health Questionnaire (EBOHQ) (Validated Questionnaire)
Measured: 16 weeks
Patients compliance with treatment.
Daily record of mouthrinse use.
Measured: 16 weeks
Patients acceptance of mouthrinse use
Mouthrinse Acceptance Form (Validated Questionnaire)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start6 Apr 2022
- Primary completionAug 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Epidermolysis BullosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación DEBRA Chile, Niños Piel de Cristal
- Responsible party
- Principal investigator, Susanne Kramer, University of Chile
- Investigators
- Susanne Kramer, MsC, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288478
- Sponsor's protocol ID
- PRI-ODO 2021/16
- Status last verified
- Apr 2022
- First submitted
- 24 Nov 2021
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Has C, Bauer JW, Bodemer C, Bolling MC, Bruckner-Tuderman L, Diem A, Fine JD, Heagerty A, Hovnanian A, Marinkovich MP, Martinez AE, McGrath JA, Moss C, Murrell DF, Palisson F, Schwieger-Briel A, Sprecher E, Tamai K, Uitto J, Woodley DT, Zambruno G, Mellerio JE. Consensus reclassification of inherited epidermolysis bullosa and other disorders with skin fragility. Br J Dermatol. 2020 Oct;183(4):614-627. doi: 10.1111/bjd.18921. Epub 2020 Mar 11.
PubMed 32017015Uitto J. Toward treatment and cure of epidermolysis bullosa. Proc Natl Acad Sci U S A. 2019 Dec 26;116(52):26147-26149. doi: 10.1073/pnas.1919347117. Epub 2019 Dec 11. No abstract available.
PubMed 31826952Has 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.
PubMed 31090061Korolenkova MV. [Dental treatment in children with dystrophic form of epidermolysis bullosa]. Stomatologiia (Mosk). 2015;94(2):34-36. doi: 10.17116/stomat201594234-36. Russian.
PubMed 26145475Puliyel D, Chiu CH, Habibian M. Restorative and periodontal challenges in adults with dystrophic epidermolysis bullosa. J Calif Dent Assoc. 2014 May;42(5):313-8.
PubMed 25087349Mello BZ, Neto NL, Kobayashi TY, Mello MB, Ambrosio EC, Yaedu RY, Machado MA, Oliveira TM. General anesthesia for dental care management of a patient with epidermolysis bullosa: 24-month follow-up. Spec Care Dentist. 2016 Jul;36(4):237-40. doi: 10.1111/scd.12170. Epub 2016 Mar 2.
PubMed 26936632Pekiner FN, Yucelten D, Ozbayrak S, Sezen EC. Oral-clinical findings and management of epidermolysis bullosa. J Clin Pediatr Dent. 2005 Fall;30(1):59-65. doi: 10.17796/jcpd.30.1.y503845545kn78x7.
PubMed 16302602Oliveira TM, Sakai VT, Candido LA, Silva SM, Machado MA. Clinical management for epidermolysis bullosa dystrophica. J Appl Oral Sci. 2008 Jan-Feb;16(1):81-5. doi: 10.1590/s1678-77572008000100016.
PubMed 19089295Kummer TR, Nagano HC, Tavares SS, Santos BZ, Miranda C. Oral manifestations and challenges in dental treatment of epidermolysis bullosa dystrophica. J Dent Child (Chic). 2013 May-Aug;80(2):97-100.
PubMed 24011299Marini I, Vecchiet F. Sucralfate: a help during oral management in patients with epidermolysis bullosa. J Periodontol. 2001 May;72(5):691-5. doi: 10.1902/jop.2001.72.5.691.
PubMed 11394407Fortuna G, Lozada-Nur F, Pollio A, Aria M, Cepeda-Valdes R, Marinkovich MP, Bruckner AL, Salas-Alanis JC. Patterns of oral mucosa lesions in patients with epidermolysis bullosa: comparison and agreement between oral medicine and dermatology. J Oral Pathol Med. 2013 Nov;42(10):733-40. doi: 10.1111/jop.12094. Epub 2013 Jun 15.
PubMed 23772832Fortuna G, Aria M, Cepeda-Valdes R, Pollio A, Moreno-Trevino MG, Salas-Alanis JC. Clinical features of gingival lesions in patients with dystrophic epidermolysis bullosa: a cross-sectional study. Aust Dent J. 2015 Mar;60(1):18-23. doi: 10.1111/adj.12264.
PubMed 25721275Brun J, Chiaverini C, Devos C, Leclerc-Mercier S, Mazereeuw J, Bourrat E, Maruani A, Mallet S, Abasq C, Phan A, Vabres P, Martin L, Bodemer C, Lagrange S, Lacour JP; Research Group of the French Society of Pediatric Dermatology. Pain and quality of life evaluation in patients with localized epidermolysis bullosa simplex. Orphanet J Rare Dis. 2017 Jun 28;12(1):119. doi: 10.1186/s13023-017-0666-5.
PubMed 28659151Stellingsma C, Dijkstra PU, Dijkstra J, Duipmans JC, Jonkman MF, Dekker R. Restrictions in oral functions caused by oral manifestations of epidermolysis bullosa. Eur J Dermatol. 2011 May-Jun;21(3):405-9. doi: 10.1684/ejd.2011.1356.
PubMed 21609900Wright JT. Comprehensive dental care and general anesthetic management of hereditary epidermolysis bullosa. A review of fourteen cases. Oral Surg Oral Med Oral Pathol. 1990 Nov;70(5):573-8. doi: 10.1016/0030-4220(90)90401-d.
PubMed 2146579
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Dose-ranging Study of Dentoxol® Mouthrinse for Managing Oral Symptoms in Epidermolysis Bullosa.
- ClinicalTrials.gov ID
- NCT05288478
- Acronym / sponsor ID
- PRI-ODO 2021/16
- Conditions
- Epidermolysis Bullosa, Oral Ulcer
- Keywords
- Epidermolysis Bullosa, Oral ulcer, Oral blisters, Dentoxol mouthrinse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Fundación DEBRA Chile, Niños Piel de Cristal
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Combination Product: Dentoxol mouthrinse dosagesFirst 6 weeks they will use the mouthrinse 5 times a day, following 4 week washout period. |
| Group A, second period | Active comparator | Combination Product: Dentoxol mouthrinse dosagesAfter 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. |
| Group B | Active comparator | Combination Product: Dentoxol mouthrinse dosagesFirst 6 weeks they will use the mouthrinse twice a day, following 4 week washout period |
| Group B, second period | Active comparator | Combination Product: Dentoxol mouthrinse dosagesAfter 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. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- People living with Inherited Epidermolysis Bullosa, including all types and subtypes, registered at Debra Foundation at the country of the study.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dentoxol mouthrinse dosagesSubjects 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. | Combination product | Group A, Group A, second period, Group B, Group B, second period |
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.
Time frame: 16 weeks
Epidermolysis Bullosa Oral Health Questionnaire (EBOHQ)
10 secondary outcomes
Change in the duration of the lesions with two different dose regimes of Dentoxol® mouthrinse and compare both effects.
Time frame: 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
Change in the recurrence of the lesions with two different dose regimes of Dentoxol® mouthrinse and compare both effects.
Time frame: 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
Change in the number of the lesions with two different dose regimes of Dentoxol® mouthrinse and compare both effects.
Time frame: 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
Change in oral pain with two different dose regimes of Dentoxol® mouthrinse and compare both effects.
Time frame: 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
Patients compliance with treatment.
Time frame: 16 weeks
Patients acceptance of mouthrinse use
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Background: PubMed 32017015Has C, Bauer JW, Bodemer C, Bolling MC, Bruckner-Tuderman L, Diem A, Fine JD, Heagerty A, Hovnanian A, Marinkovich MP, Martinez AE, McGrath JA, Moss C, Murrell DF, Palisson F, Schwieger-Briel A, Sprecher E, Tamai K, Uitto J, Woodley DT, Zambruno G, Mellerio JE. Consensus reclassification of inherited epidermolysis bullosa and other disorders with skin fragility. Br J Dermatol. 2020 Oct;183(4):614-627. doi: 10.1111/bjd.18921. Epub 2020 Mar 11.
- Background: PubMed 31826952Uitto J. Toward treatment and cure of epidermolysis bullosa. Proc Natl Acad Sci U S A. 2019 Dec 26;116(52):26147-26149. doi: 10.1073/pnas.1919347117. Epub 2019 Dec 11. No abstract available.
- Background: PubMed 31090061Has 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.
- Background: PubMed 26145475Korolenkova MV. [Dental treatment in children with dystrophic form of epidermolysis bullosa]. Stomatologiia (Mosk). 2015;94(2):34-36. doi: 10.17116/stomat201594234-36. Russian.
- Background: PubMed 25087349Puliyel D, Chiu CH, Habibian M. Restorative and periodontal challenges in adults with dystrophic epidermolysis bullosa. J Calif Dent Assoc. 2014 May;42(5):313-8.
- Background: PubMed 26936632Mello BZ, Neto NL, Kobayashi TY, Mello MB, Ambrosio EC, Yaedu RY, Machado MA, Oliveira TM. General anesthesia for dental care management of a patient with epidermolysis bullosa: 24-month follow-up. Spec Care Dentist. 2016 Jul;36(4):237-40. doi: 10.1111/scd.12170. Epub 2016 Mar 2.
- Background: PubMed 16302602Pekiner FN, Yucelten D, Ozbayrak S, Sezen EC. Oral-clinical findings and management of epidermolysis bullosa. J Clin Pediatr Dent. 2005 Fall;30(1):59-65. doi: 10.17796/jcpd.30.1.y503845545kn78x7.
- Background: PubMed 19089295Oliveira TM, Sakai VT, Candido LA, Silva SM, Machado MA. Clinical management for epidermolysis bullosa dystrophica. J Appl Oral Sci. 2008 Jan-Feb;16(1):81-5. doi: 10.1590/s1678-77572008000100016.
- Background: PubMed 24011299Kummer TR, Nagano HC, Tavares SS, Santos BZ, Miranda C. Oral manifestations and challenges in dental treatment of epidermolysis bullosa dystrophica. J Dent Child (Chic). 2013 May-Aug;80(2):97-100.
- Background: PubMed 11394407Marini I, Vecchiet F. Sucralfate: a help during oral management in patients with epidermolysis bullosa. J Periodontol. 2001 May;72(5):691-5. doi: 10.1902/jop.2001.72.5.691.
- Background: PubMed 23772832Fortuna G, Lozada-Nur F, Pollio A, Aria M, Cepeda-Valdes R, Marinkovich MP, Bruckner AL, Salas-Alanis JC. Patterns of oral mucosa lesions in patients with epidermolysis bullosa: comparison and agreement between oral medicine and dermatology. J Oral Pathol Med. 2013 Nov;42(10):733-40. doi: 10.1111/jop.12094. Epub 2013 Jun 15.
- Background: PubMed 25721275Fortuna G, Aria M, Cepeda-Valdes R, Pollio A, Moreno-Trevino MG, Salas-Alanis JC. Clinical features of gingival lesions in patients with dystrophic epidermolysis bullosa: a cross-sectional study. Aust Dent J. 2015 Mar;60(1):18-23. doi: 10.1111/adj.12264.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne Kramer, MsC principal investigator
University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dentoxol mouthrinse dosages in people with Epidermolysis Bullosa and Oral Ulcer, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05288478, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.