The Effect of Medical Grade Honey Formulation (L-Mesitran) Administration on Recurrent Vulvovaginal Candidiasis Symptoms

A Randomized Controlled Trial: the Effect of a Medical Grade Honey Formulation (L-Mesitran) on Clinical Symptoms of Recurrent Vulvovaginal Candidiasis

The aim of the study is to investigate the efficacy of Fluconazol versus L-Mesitran in the treatment of patients with recurrent vulvovaginal candidiasis. Vaginal swabs will be analyzed after 1, 6 and 12 months. The study ends after 252 included patients completed the study.

Study Overview

• Status: Recruiting
• Conditions: Candidiasis, Vulvovaginal; Recurrent Candidiasis of Vagina
• Intervention / Treatment: Drug: Fluconazole; Device: L-Mesitran

Detailed Description

The purpose of this study is to investigate the vaginal culture (positive or negative) after the application of a Medical Grade Honey formulation (L-Mesitran ®) in relation to the current standard of care (Fluconazole) 1 month after starting treatment in patients with RVCC. As a secondary outcome, the effects on symptoms, including redness, irritation, itching, dysuria, dyspareunia and vaginal discharge will be analyzed. In addition, the vaginal culture after 6 months maintenance application and the number of relapses within 12 months will be investigated. Moreover, information about side effects, discomfort, and quality of life will be collected and compared. The study ends after 252 included patients completed the study.

• Study Type: Interventional
• Enrollment (Anticipated): 252
• Phase: Phase 3

Contacts and Locations

Study Locations

• Netherlands
  • Heerlen, Netherlands
    • Recruiting
    • Zuyderland Medical Centre
    • Contact: Senna van Riel, MD; Phone Number: +31884599702; Email: honing@zuyderland.nl
  • Maastricht, Netherlands
    • Recruiting
    • MaastrichtUMC
    • Contact: Celine Lardenoije, MD; Phone Number: +31433874800; Email: honing.gyn@mumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women of at least 18 years old
• Recurrent vulvovaginal candidiasis (At least 3 episodes of clinical symptoms during the last year)
• Clinical and microbiological diagnosis of (recurrent) vulvovaginal candidiasis at time of consultation
• Capacity to understand, consent, and comply with the trial procedures

Exclusion Criteria:

• Mixed vaginal infections
• Pregnancy or the intention to become pregnant during the study period
• Women using systemic or topical antifungal medication during the last 2 weeks prior to inclusion
• Known allergies or contra-indications for Fluconazole or honey
• Candida with resistance for Fluconazole
• Women giving breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fluconazole; Way of administration: oral capsules. One capsule at the same day of the week. Dosage: As treatment for active RVVC- in the first week on day 1 one capsule 150 mg Fluconazole, on day 4 one capsule 150 mg Fluconazole and on day 7 one capsule 150 mg Fluconazole. As prophylaxis to prevent a new RVVC episode: one capsule Fluconazol 150 mg per week for a duration of 6 months.	Drug: Fluconazole; Way of administration: oral capsules. One capsule at the same day of the week. Dosage: As treatment for active RVVC- in the first week on day 1 one capsule 150 mg Fluconazole, on day 4 one capsule 150 mg Fluconazole and on day 7 one capsule 150 mg Fluconazole. As prophylaxis to prevent a new RVVC episode: one capsule Fluconazol 150 mg per week for a duration of 6 months.; Other Names: diflucan
Experimental: L-Mesitran; Way of administration: intra-vaginal application using an applicator. Dosage: As treatment for active RVVC - Single daily application (5 grams) for 1 month. As prophylaxis to prevent a new RVVC episode: Single weekly (5 grams) application for 5 months.	Device: L-Mesitran; Way of administration: intra-vaginal application using an applicator. Dosage: As treatment for active RVVC - Single daily application (5 grams) for 1 month. As prophylaxis to prevent a new RVVC episode: Single weekly (5 grams) application for 5 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vaginal swab	The main study parameter is the mycological cure rate after one month of therapy for both the treatment (L-Mesitran) and control (Diflucan) groups. The vaginal swab will be analyzed in the laboratory to determine the presence or absence of microorganisms and thus the mycological cure rate.	1 month
vaginal swab	The main study parameter is the mycological cure rate after one month of therapy for both the treatment (L-Mesitran) and control (Diflucan) groups. However, the long term cure (after 6 months) will also be evaluated using vaginal swabs in which the presence or absence of microorganisms will be analyzed in the laboratory (mycological cure).	6 months
vaginal swab	The main study parameter is the mycological cure rate after one month of therapy for both the treatment (L-Mesitran) and control (Diflucan) groups. However, the long term cure (after 6 months) will also be evaluated using vaginal swabs in which the presence or absence of microorganisms will be analyzed in the laboratory (mycological cure).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life will be determined with questionnaires	The secondary objectives are to investigate the effects of both treatments on the symptoms, including redness, irritation, itching, dysuria, dyspareunia, vaginal discharge, after 1, 6, 9, and 12 months of therapy. In addition, the prophylactic activity after 6 months maintenance treatment, and the long-term efficacy as number of relapses within 12 months will be investigated. These parameters will be evaluated using the questionnaires asking the severity, frequency and duration of each parameter.	1 month
Quality of life will be determined with questionnaires	The secondary objectives are to investigate the effects of both treatments on the symptoms, including redness, irritation, itching, dysuria, dyspareunia, vaginal discharge, after 1, 6, 9, and 12 months of therapy. In addition, the prophylactic activity after 6 months maintenance treatment, and the long-term efficacy as number of relapses within 12 months will be investigated. These parameters will be evaluated using the questionnaires asking the severity, frequency and duration of each parameter.	6 months
Quality of life will be determined with questionnaires	The secondary objectives are to investigate the effects of both treatments on the symptoms, including redness, irritation, itching, dysuria, dyspareunia, vaginal discharge, after 1, 6, 9, and 12 months of therapy. In addition, the prophylactic activity after 6 months maintenance treatment, and the long-term efficacy as number of relapses within 12 months will be investigated. These parameters will be evaluated using the questionnaires asking the severity, frequency and duration of each parameter.These parameters will be evaluated using the questionnaires asking the severity, frequency and duration of each parameter.	9 months
Quality of life will be determined with questionnaires	The secondary objectives are to investigate the effects of both treatments on the symptoms, including redness, irritation, itching, dysuria, dyspareunia, vaginal discharge, after 1, 6, 9, and 12 months of therapy. In addition, the prophylactic activity after 6 months maintenance treatment, and the long-term efficacy as number of relapses within 12 months will be investigated. These parameters will be evaluated using the questionnaires asking the severity, frequency and duration of each parameter.	12 months
Side effects of medication will be determined with questionnaires	Information about side effects, discomfort, quality of life and therapy compliance for both treatments will be collected and compared. These parameters will be evaluated using the questionnaires (open questions).	1 month
Side effects of medication will be determined with questionnaires	Information about side effects, discomfort, quality of life and therapy compliance for both treatments will be collected and compared. These parameters will be evaluated using the questionnaires (open questions).	6 months
Side effects of medication will be determined with questionnaires	Information about side effects, discomfort, quality of life and therapy compliance for both treatments will be collected and compared. These parameters will be evaluated using the questionnaires (open questions).	9 months
Side effects of medication will be determined with questionnaires	Information about side effects, discomfort, quality of life and therapy compliance for both treatments will be collected and compared. These parameters will be evaluated using the questionnaires (open questions).	12 months

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Zuyderland Medical Centre

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2022
• Primary Completion (Anticipated): April 22, 2026
• Study Completion (Anticipated): April 22, 2027

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: L-Mesitran; Fluconazol; vaginal swabs; medical grade honey; antifungal activity
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Bacterial Infections and Mycoses; Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Vulvovaginitis; Candidiasis; Recurrence; Candidiasis, Vulvovaginal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Fluconazole
• Other Study ID Numbers: NL73974.068.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data and conclusions that emerge from the study will be described in one or more articles in international peer-reviewed journal(s) and will follow the CCMO guidelines. In addition, the data may also be submitted for presentation at medical congresses. Data and reprints may be shared upon reasonable request. Individual participant data after deidentification may be shared with researchers who provide a methodologically sound proposal. Proposals should be addressed to the principal investigators or corresponding authors within 36 months following article publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No