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Study on Fluconazole and Cefalexin Monohydrate for Treating Laryngeal Leukoplakia in Adults

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on the treatment of laryngeal leukoplakia, a condition characterized by white patches on the vocal cords, which can potentially lead to more serious health issues if left untreated. The study will explore the effectiveness of two medications: Diflucan (fluconazole) and Kefexin (cefalexin monohydrate). Diflucan is administered as a hard capsule, while Kefexin is provided as a film-coated tablet. Both medications are taken orally.

The purpose of this study is to determine whether these antimicrobial treatments can help in the disappearance of leukoplakia. Participants in the study will receive either one of the medications or a placebo. The study will last for a maximum of six months, during which participants will be monitored for changes in their condition.

Throughout the study, participants will be required to take the medication as prescribed and attend regular check-ups to assess their progress. The ultimate goal is to see if these treatments can effectively reduce or eliminate the white patches associated with laryngeal leukoplakia, thereby improving the health and quality of life for those affected by this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be informed about the purpose of the trial, which is the antimicrobial treatment of laryngeal leukoplakia.

    The patient will be assessed to ensure they meet the inclusion criteria, specifically having a diagnosis of laryngeal leukoplakia.

  2. Step 2

    Medication administration

    The patient will begin treatment with two medications: Diflucan 100 mg and Kefexin 500 mg.

    Diflucan is administered as a hard capsule taken orally.

    Kefexin is administered as a film-coated tablet taken orally.

  3. Step 3

    Treatment schedule

    The patient will take Diflucan 100 mg once daily.

    The patient will take Kefexin 500 mg twice daily.

    The duration of the treatment will be determined by the study protocol and will continue until the primary endpoint is reached.

  4. Step 4

    Monitoring and evaluation

    The patient's progress will be monitored regularly to assess the disappearance of leukoplakia.

    Regular check-ups will be scheduled to evaluate the effectiveness of the treatment and to monitor any side effects.

  5. Step 5

    Completion of the study

    The study is estimated to end by December 30, 2029.

    Upon completion, the patient's condition will be evaluated to determine the success of the treatment.

Who can join the trial?

4 criteria

  • The patient must have a condition called laryngeal leukoplakia. This is a condition where there are white patches on the voice box.
  • The patient must be within a certain age range, specifically between 18 and 64 years old.
  • Both male and female patients can participate in the study.
  • The patient should not be part of a vulnerable population, meaning they should not have additional factors that make them more at risk.

Who cannot join the trial?

3 criteria

  • Individuals who are not within the specified age range for the study.
  • Individuals who have medical conditions other than laryngeal leukoplakia, which is a condition where white patches form on the voice box.
  • Individuals who are part of a vulnerable population, meaning they might need special protection or care.
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Investigated drugs

Antimicrobial Treatment is used in this clinical trial to treat laryngeal leukoplakia. This therapy involves using medications that help fight infections caused by bacteria or other microorganisms. The goal is to reduce or eliminate the white patches in the larynx, which are characteristic of leukoplakia, by targeting any underlying microbial causes.

What is already known about the treatment

Antimicrobial Treatment – This medication is administered orally or topically, depending on the specific formulation used in the treatment of laryngeal leukoplakia. Currently, it is under investigation in clinical trials to assess its effectiveness and safety for this condition. The main therapeutic indication is the treatment of laryngeal leukoplakia, a condition characterized by white patches on the larynx that can potentially lead to cancer. The medication works by targeting and eliminating harmful microorganisms that may contribute to the development or persistence of these patches. It is classified pharmacologically as an antimicrobial agent, which means it is designed to combat bacterial, viral, or fungal infections.

Investigated diseases

Laryngeal Leukoplakia – Laryngeal leukoplakia is a condition characterized by the formation of white patches on the mucous membranes of the larynx. These patches are caused by an abnormal growth of cells and can vary in size and thickness. The condition is often associated with irritation from smoking, alcohol use, or other environmental factors. Over time, the patches may become more pronounced and can potentially lead to changes in voice quality or discomfort in the throat. The progression of laryngeal leukoplakia can vary, with some cases remaining stable while others may develop further complications. Regular monitoring is important to assess any changes in the condition.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518793-14-00Estimated enrolment90 patientsSponsorHUS-yhtymae

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).