Oral UlcerPhase 1PHENO-FILMNCT07890428
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
A Phase 1 study testing 1% Phenytoin Mucoadhesive Film and Blank Mucoadhesive Film in people with Oral Ulcer and Oral Mucositis, run by Misr University for Science and Technology at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if a new 1% Phenytoin mucoadhesive film is safe and works to treat oral ulcers in healthy adult volunteers and patients with oral ulcers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Ulcer, Oral Mucositis, Aphthous Stomatitis
- What is being tested?
- 1% Phenytoin Mucoadhesive Film and Blank Mucoadhesive Film
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2026to 20 Jan 2027
- Phase
- Phase 1
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female adults aged 18 to 50 years.
- General good health, confirmed by medical history, physical examination, vital signs, and clinical laboratory tests (hematology, biochemistry, urinalysis).
- Body Mass Index (BMI) between 18.5 and 30 kg/m².
- For patients with existing ulcers: Clinical diagnosis of at least one oral ulcer (e.g., recurrent aphthous stomatitis) with a diameter between 3 mm and 10 mm at baseline.
- For healthy volunteers: no current oral lesions.
- Ability to understand and provide written informed consent.
- Willingness to comply with all study procedures, including daily clinic visits and application of the film for 7 consecutive days.
- Women of childbearing potential must have a negative pregnancy test at screening and agree to use highly effective contraception during the study.
Who cannot join
- Known hypersensitivity or allergy to phenytoin, other hydantoins, or any excipients in the mucoadhesive film.
- Clinically significant cardiovascular, hepatic, renal, gastrointestinal, hematologic, or psychiatric disease.
- Presence of severe oral pathology, oral candidiasis, or active oral infection (e.g., herpes simplex) that could confound ulcer assessments.
- Use of any systemic or topical medication for oral ulcers (e.g., corticosteroids, anesthetics) within 7 days prior to enrollment.
- Use of drugs known to interact with phenytoin (e.g., warfarin, folic acid, certain antibiotics, and antifungals) within 30 days prior to enrollment.
- History of heavy smoking (more than 10 cigarettes/day) or alcohol abuse, as these impair wound healing.
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- Pregnant or breastfeeding women.
- Participation in another investigational drug or device study within 30 days prior to screening.
- Immunocompromised status (e.g., HIV positive, chronic hepatitis, or current immunosuppressive therapy).
- Any condition that, in the opinion of the Investigator, would compromise the safety of the participant or the quality of the study data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Misr University For Science and Technology
Giza, Cairo Governorate, 21634
yassmine farouk, 01005080494, mdiaah47@gmail.com
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Tolerability of 1% Phenytoin Mucoadhesive Film in Healthy Adult Volunteers
The goal of this clinical trial is to learn if a new 1% Phenytoin mucoadhesive film is safe and works to treat oral ulcers in healthy adult volunteers and patients with oral ulcers.
The main questions it aims to answer are the following:
Read more
Is the 1% Phenytoin film safe and well-tolerated when placed on oral ulcers? Does the film reduce pain and improve ulcer healing compared to a blank film?
Researchers will compare participants receiving the 1% Phenytoin mucoadhesive film to those receiving a blank (placebo) film to see if the active film improves healing and reduces pain.
Participants will:
Have the assigned film placed directly over their oral ulcer once daily for 7 consecutive days.
Attend regular clinic visits for check-ups, including blood tests and monitoring of ulcer appearance, body weight, and food intake.
Report any pain, discomfort, or changes in their condition to the research team.
Read the detailed description
Background and Rationale:
Oral ulcers and oral mucositis are painful conditions that significantly impact patients' quality of life. Current topical treatments, such as mouthwashes, often have limited efficacy due to short contact time with the oral mucosa. Phenytoin has been shown to promote wound healing by enhancing fibroblast proliferation, collagen deposition, and angiogenesis while reducing inflammation. The development of a mucoadhesive film formulation is expected to enhance local drug retention, providing sustained release and improving therapeutic outcomes compared to conventional mouthwashes. This study aims to translate these preclinical findings into a human clinical setting.
Study Design and Methodology:
This is a Phase I, single-center, randomized, controlled clinical trial. A total of 10 healthy adult volunteers and patients with oral ulcers will be enrolled. Participants will be randomized into two parallel groups:
- Test Group:Participants will receive a 1% Phenytoin mucoadhesive film.
- Control Group:Participants will receive a blank (placebo) mucoadhesive film.
The assigned film will be placed directly over the ulcerated buccal mucosa once daily for 7 consecutive days. Participants will be closely monitored for safety and tolerability throughout the treatment period.
Objectives:
Primary Objective:To evaluate the safety, tolerability, and systemic absorption of the 1% Phenytoin mucoadhesive film in humans.
Secondary Objectives:To assess preliminary efficacy signals of the film in reducing ulcer size, alleviating pain, and accelerating healing time compared to the placebo film.
Safety Monitoring and Assessments:
Participants will undergo daily clinical evaluations, including assessment of ulcer appearance, vital signs, local irritation, and behavioral changes. Adverse events will be recorded. If systemic absorption is detected, monitoring will include standard hematological and biochemical parameters. All findings will be recorded in standardized laboratory data sheets, and any severe adverse reactions will be managed according to institutional human welfare guidelines.
Statistical Analysis:
Due to the small sample size (N=10), this study is primarily descriptive and not powered to detect statistically significant differences in efficacy. Demographic, safety, and efficacy data will be summarized using descriptive statistics (means, standard deviations, medians, and ranges for continuous variables; frequencies and percentages for categorical variables). Exploratory comparisons between the test and control groups may be performed using non-parametric tests (e.g., Mann-Whitney U test) where appropriate, but results should be interpreted with caution due to the limited sample size. All findings, including negative or inconclusive results, will be reported in accordance with good clinical practice.
- Conditions
- Oral Ulcer, Oral Mucositis, Aphthous Stomatitis
- Being tested
- 1% Phenytoin Mucoadhesive Film, Blank Mucoadhesive Film
- Keywords
- Phenytoin, Mucoadhesive Film, Oral Ulcer, Oral Mucositis, Phase I Clinical Trial, Wound Healing, Safety and Tolerability, Placebo-Controlled
- Medical subject headings
- Oral Ulcer, Stomatitis, Stomatitis, Aphthous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% Phenytoin Mucoadhesive FilmDrug
A novel mucoadhesive film formulation containing 1% Phenytoin as the active pharmaceutical ingredient. The film is designed to adhere directly to the buccal mucosa over an oral ulcer, providing sustained local release of the drug to promote wound healing and reduce inflammation. It is applied topically once daily for 7 consecutive days. This formulation differs from standard phenytoin mouthwashes by providing prolonged mucosal contact time, thereby enhancing drug retention at the site of the ulcer
Blank Mucoadhesive FilmDrug
A blank (placebo) mucoadhesive film that is identical in physical appearance, size, and application method to the active 1% Phenytoin film but contains no active pharmaceutical ingredient. It is designed to serve as a negative control to assess the true therapeutic effect of the Phenytoin film. Like the active film, it is applied directly to the oral ulcer once daily for 7 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| 1% Phenytoin Mucoadhesive Film | Experimental | Participants will receive a 1% Phenytoin mucoadhesive film placed directly over the oral ulcer once daily for 7 consecutive days Receives: Drug: 1% Phenytoin Mucoadhesive Film |
| Blank Mucoadhesive Film | Placebo comparator | Participants will receive a blank (placebo) mucoadhesive film placed directly over the oral ulcer once daily for 7 consecutive days Receives: Drug: Blank Mucoadhesive Film |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Incidence, severity, and type of local and systemic adverse events (AEs), including local irritation at the application site, changes in vital signs, body weight, and abnormal clinical laboratory findings
Measured: From baseline (Day 1) through the end of the 7-day treatment period
Secondary outcomes (3)
Change in Oral Ulcer Size
Measurement of the reduction in ulcer diameter (in millimeters) from baseline to the end of treatment
Measured: Baseline Day 1 to Day 7
Change in Oral Ulcer Pain Intensity
Assessment of pain using a Visual Analog Scale (VAS) or Numeric Rating Scale (NRS) reported by the participant daily
Measured: Baseline Day 1 to Day 7
Time to Complete Ulcer Healing
The number of days required for complete re-epithelialization (healing) of the oral ulcer
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion20 Nov 2026 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral UlcerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Misr University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Diaa, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890428
- Sponsor's protocol ID
- PTREC 37A
- Acronym
- PHENO-FILM
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No