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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Hacnmlcp Uzwskqdjrr Cfunczz Hbyxudqd Helsinki Finland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Finland Finland
Not yet recruiting
01.01.2022

Trial locations

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.

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 ID:
2024-518793-14-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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