Evaluation of Fluconazole and Cefalexin Monohydrate in the Antimicrobial Management of Laryngeal Leukoplakia in Adult Patients

The primary objective of this study is to evaluate the efficacy of **antimicrobial treatment** in patients with **laryngeal leukoplakia**. This condition is characterized by white patches on the larynx, which can potentially progress to malignancy. The study aims to determine the therapeutic impact of two antimicrobial agents, **fluconazole** and **cefalexin monohydrate**, administered orally. The clinical relevance of this objective lies in the potential to provide an effective treatment strategy that could prevent the progression of laryngeal leukoplakia to more severe conditions, thereby improving patient outcomes and reducing the risk of malignancy.

The clinical trial focuses on the **antimicrobial treatment** of **laryngeal leukoplakia**. The study population includes both male and female participants, with an age range that spans from young adults to older adults. The trial does not specifically target a vulnerable population. Participants were selected based on the presence of laryngeal leukoplakia, as this is a principal inclusion criterion. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet, physical activity, or habits. The trial aims to evaluate the efficacy of the treatment in a diverse group of individuals affected by this condition.

The clinical trial is designed to evaluate the **antimicrobial treatment** of **laryngeal leukoplakia** using two pharmaceutical products: Diflucan 100 mg hard capsules containing **fluconazole** and Kefexin 500 mg film-coated tablets containing **cefalexin monohydrate**. This is a Phase IV, randomized, double-blind, controlled trial. The trial is expected to run from January 1, 2022, to December 30, 2029, with an estimated duration of participant involvement of up to six months. The primary endpoint is the disappearance of leukoplakia.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on the principal inclusion criterion of having laryngeal leukoplakia. Following successful screening, participants will be randomized to receive either Diflucan or Kefexin, administered orally. The trial includes regular follow-up visits to monitor the participants' response to treatment and to ensure adherence to the study protocol. These visits will also serve to collect data on any adverse events and to adjust dosages if necessary, within the maximum daily dose limits of 100 mg for fluconazole and 1500 mg for cefalexin monohydrate.

The end-of-study visit will occur at the conclusion of the treatment period, where final assessments will be conducted to evaluate the primary endpoint. Participants may be withdrawn from the study early if they experience significant adverse effects, fail to comply with the study protocol, or if the investigator deems it necessary for the participant's safety. The trial is not classified as a low-intervention study, and all procedures will adhere to the highest standards of clinical research to ensure the safety and well-being of participants.

The clinical trial involves the use of two experimental medications for the treatment of **laryngeal leukoplakia**. The first medication is **Diflucan 100 mg**, which is presented in the form of a hard capsule. The active substance in Diflucan is **fluconazole**, a chemical compound classified under the ATC code J02AC01. The medication is administered orally, with a maximum daily dose of 100 mg and a total maximum dose of 4200 mg over a treatment period of up to 6 weeks. The capsules are manufactured by Pfizer Oy and are not formulated for pediatric use. Participant compliance with the dosing schedule will be monitored throughout the trial.

The second experimental medication is **Kefexin 500 mg**, available as a film-coated tablet. The active ingredient in Kefexin is **cefalexin monohydrate**, also a chemical substance. This medication is administered orally, with a maximum daily dose of 1500 mg and a total maximum dose of 63000 mg over a treatment period of up to 6 weeks. Kefexin is produced by Orion Corporation and, similar to Diflucan, is not intended for pediatric use. The trial will ensure adherence to the dosing regimen through regular monitoring of participant compliance.

No non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatments, are specified for this study. The trial focuses solely on the administration and effects of the experimental medications, Diflucan and Kefexin, in the context of treating laryngeal leukoplakia.

Efficacy in the clinical trial titled "Antimicrobial treatment of laryngeal leukoplakia" will be assessed primarily through the evaluation of the **disappearance of leukoplakia**. This endpoint serves as the primary measure of treatment success. The trial involves the use of two medicinal products: Diflucan 100 mg capsules containing the active substance **fluconazole**, and Kefexin 500 mg film-coated tablets containing **cefalexin monohydrate**. Both products are administered orally. The maximum treatment period for each product is six months. The trial is categorized as a Phase IV study, focusing on the use of authorized medicinal products. The assessment of efficacy will be conducted at specified intervals throughout the treatment period, with the primary endpoint being the complete resolution of leukoplakia. Data collection and analysis will be performed in accordance with standard clinical trial protocols to ensure the reliability and validity of the results.