Minor Recurrent Aphthous Stomatitis LesionsEarly Phase 1NCT02142543
The Effect of 2-DeNT Oral Topical Powder on Minor Recurrent Aphthous Ulcer
A Early Phase 1 study testing 2-DeNT powder in people with Minor Recurrent Aphthous Stomatitis Lesions, run by Texas A&M University at 1 site in United States.
Trial summary
This is a prospective, randomized, blinded, placebo-controlled, crossover clinical trial to evaluate the efficacy of 2-DeNT oral topical powder in the treatment of recurrent aphthous stomatitis (RAS). To be included in the study, subjects must have had minor RAS ulcers of less than 48 hours duration. Read more about this study
- Who is it for?
- Ages 12 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Minor Recurrent Aphthous Stomatitis Lesions
- What is being tested?
- 2-DeNT powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Dec 2012
- Phase
- Early Phase 1
- 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 12 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- a history of minor recurrent aphthous stomatitis (RAS) lesions occurring at least 3-4 time/ year, and usually requiring 5 or more days to resolve
- presence of an active ulcer of less than 48 hours duration on either the buccal or labial mucosa (making them more easily accessible for powder application)
- willing and able to give informed consent
Who cannot join
- pregnant or lactating
- if ulcers were manifestations of a systemic disease process such as ulcerative colitis, Crohn's disease, Behcet's syndrome, or anemia;
- concurrent clinical conditions that could either pose a health risk to the patient by being involved in the study or potentially influence the outcome of the study
- hypersensitivity to dexamethasone, diphenhydramine, tetracycline, metronidazole, nystatin, karaya gum, or zinc oxide
- having used corticosteroids, oral retinoids, or other immunomodulatory agents within one month of participation in the study; non-steroidal anti-inflammatory agents (e.g., aspirin, ibuprofen, etc.), acetaminophen, or oral antihistamines chronically within one month of participation in the study or any use within five days of participation in the study; topical medication (including steroids, retinoids, and anti-microbial drugs) within two weeks of participation in the study, systemic antibiotics within two weeks of participation in the study; any preparation or medication (OTC or prescription) applied to the ulcer within 48 hours of participation in the study
- history of drug or alcohol abuse
Show all 9Show fewer
- having had any dental work within 2 weeks of study entry
- having had any orthodontic or oral appliances (that could cause oral trauma) within 1 cm of the ulcer or any recollection of trauma in the area of the ulcer
- participating in any other study involving investigational or marketed products within 1 month of study entry or plans to participate in such an investigation during this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas A&M Baylor College of Dentisry
Dallas, Texas, 75246
About this study
This is a prospective, randomized, blinded, placebo-controlled, crossover clinical trial to evaluate the efficacy of 2-DeNT oral topical powder in the treatment of recurrent aphthous stomatitis (RAS). To be included in the study, subjects must have had minor RAS ulcers of less than 48 hours duration. It was randomly determined which powder was used first; all subjects used both the 2-DeNT powder and the placebo powder. Subjects applied the powder twice daily and maintained a daily log recording the size of the ulcer, its erythema score, and their level of pain. The subjects continued applying the 2-DeNT powder until the ulcer was resolved.
- Being tested
- 2-DeNT powder, Placebo Comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-DeNT powderDrug
powder included dexamethasone, diphenhydramine, tetracycline, metronidazole, nystatin, zinc oxide, and karaya gum
Placebo ComparatorDrug
Also called placebo powder containing zinc oxide, karaya gum, and yellow dye, which was added to imitate the color of the original powder
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | placebo powder containing zinc oxide, karaya gum, and yellow dye, which was added to imitate the color of the original powder, applied twice a day until the ulcer had resolved, an expected average of 3-5 days Receives: Drug: Placebo Comparator |
| 2-DeNT powder | Experimental | 2-DeNT powder containing dexamethasone, diphenhydramine, tetracycline, metronidazole, nystatin, zinc oxide, and karaya gum, applied twice a day until the ulcer had resolved, applied twice a day until the ulcer had resolved, in an expected average of 3 to 5 days Receives: Drug: 2-DeNT powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcer size
Size was measured from the outside edge of the white border to the outside edge of the opposite white border. If the ulcer was oval in shape, its longest dimension was measured.
Measured: From time of randomization until ulcer was healed, an expected average of 3 to 5 days
Secondary outcomes (1)
Erythema
Erythema levels were recorded on a scale of 0 to 4 (0= no redness, 1= faint redness, 2= light red/pink, 3= moderate redness, 4= severe redness) using a guide that provided both picture and word descriptions of the degree of redness associated with each number on the scale
Measured: From time of randomization until ulcer was healed, an expected average of 3 to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startMar 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minor Recurrent Aphthous Stomatitis LesionsStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142543
- Sponsor's protocol ID
- BCDOrtho1
- Other IDs
- 2011-23-BCD
- Status last verified
- Jun 2014
- First submitted
- 24 Apr 2014
- Last updated
- 6 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 2-DeNT Oral Topical Powder on Minor Recurrent Aphthous Ulcer
- ClinicalTrials.gov ID
- NCT02142543
- Acronym / sponsor ID
- BCDOrtho1
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 May 2014 (estimated)
- 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.
This is a prospective, randomized, blinded, placebo-controlled, crossover clinical trial to evaluate the efficacy of 2-DeNT oral topical powder in the treatment of recurrent aphthous stomatitis (RAS). To be included in the study, subjects must have had minor RAS ulcers of less than 48 hours duration. It was randomly determined which powder was used first; all subjects used both the 2-DeNT powder and the placebo powder. Subjects applied the powder twice daily and maintained a daily log recording the size of the ulcer, its erythema score, and their level of pain. The subjects continued applying the 2-DeNT powder until the ulcer was resolved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placebo Comparatorplacebo powder containing zinc oxide, karaya gum, and yellow dye, which was added to imitate the color of the original powder, applied twice a day until the ulcer had resolved, an expected average of 3-5 days |
| 2-DeNT powder | Experimental | Drug: 2-DeNT powder2-DeNT powder containing dexamethasone, diphenhydramine, tetracycline, metronidazole, nystatin, zinc oxide, and karaya gum, applied twice a day until the ulcer had resolved, applied twice a day until the ulcer had resolved, in an expected average of 3 to 5 days |
Who may qualify
- Ages
- 12 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- a history of minor recurrent aphthous stomatitis (RAS) lesions occurring at least 3-4 time/ year, and usually requiring 5 or more days to resolve
- presence of an active ulcer of less than 48 hours duration on either the buccal or labial mucosa (making them more easily accessible for powder application)
- willing and able to give informed consent
Key exclusion criteria (9 listed)
- pregnant or lactating
- if ulcers were manifestations of a systemic disease process such as ulcerative colitis, Crohn's disease, Behcet's syndrome, or anemia;
- concurrent clinical conditions that could either pose a health risk to the patient by being involved in the study or potentially influence the outcome of the study
- hypersensitivity to dexamethasone, diphenhydramine, tetracycline, metronidazole, nystatin, karaya gum, or zinc oxide
- having used corticosteroids, oral retinoids, or other immunomodulatory agents within one month of participation in the study; non-steroidal anti-inflammatory agents (e.g., aspirin, ibuprofen, etc.), acetaminophen, or oral antihistamines chronically within one month of participation in the study or any use within five days of participation in the study; topical medication (including steroids, retinoids, and anti-microbial drugs) within two weeks of participation in the study, systemic antibiotics within two weeks of participation in the study; any preparation or medication (OTC or prescription) applied to the ulcer within 48 hours of participation in the study
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 |
|---|---|---|
| 2-DeNT powderpowder included dexamethasone, diphenhydramine, tetracycline, metronidazole, nystatin, zinc oxide, and karaya gum | Drug | 2-DeNT powder |
| Placebo ComparatorAlso: placebo powder containing zinc oxide, karaya gum, and yellow dye, which was added to imitate the color of the original powder | Drug | placebo |
Primary outcome
Ulcer size
Time frame: From time of randomization until ulcer was healed, an expected average of 3 to 5 days
Size was measured from the outside edge of the white border to the outside edge of the opposite white border. If the ulcer was oval in shape, its longest dimension was measured.
1 secondary outcome
Erythema
Time frame: From time of randomization until ulcer was healed, an expected average of 3 to 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 2-DeNT powder in people with Minor Recurrent Aphthous Stomatitis Lesions, run by Texas A&M University at 1 site in United States.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 6 Jun 2014. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ulcer size (time frame: From time of randomization until ulcer was healed, an expected average of 3 to 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2014.