A Phase 1 interventional study of 1% Phenytoin Mucoadhesive Film and Blank Mucoadhesive Film in Oral Ulcer, Oral Mucositis and Aphthous Stomatitis, sponsored by Misr University for Science and Technology. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Misr University for Science and Technology · Phase 1, Interventional, and Treatment
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:
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.
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:
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.
43 studies on the registry are indexed under Oral Ulcer; 8 are open to participants now.
This study's planned enrollment of 10 is below the median of 47 across 38 interventional studies indexed under Oral Ulcer.
Browse Oral Ulcer studies →Misr University for Science and Technology is the lead sponsor of 38 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Participants will receive a 1% Phenytoin mucoadhesive film placed directly over the oral ulcer once daily for 7 consecutive days
Drug: 1% Phenytoin Mucoadhesive Film
Participants will receive a blank (placebo) mucoadhesive film placed directly over the oral ulcer once daily for 7 consecutive days
Drug: Blank Mucoadhesive Film
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
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
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
Time frame: From baseline (Day 1) through the end of the 7-day treatment period
Change in Oral Ulcer Size
Measurement of the reduction in ulcer diameter (in millimeters) from baseline to the end of treatment
Time frame: 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
Time frame: 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
Time frame: Up to 7 days
Start is estimated for Oct 2026; primary completion for Nov 2026, 1 month later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Misr University for Science and Technology