Efficacy, Safety LactiSal 1% Gel, LactSal 50 mg, Clotrimazole 100 mg Tablet in Treatment Vulvovaginal Candidiasis

Comparative Study of the Efficacy and Safety of LactiSal 1% Vaginal Gel and LactSal 50 mg Vaginal Tablet Versus Clotrimazole 100 mg Vaginal Tablet in the Treatment of Vulvovaginal Candidiasis (VVC)

The purpose of this study is to compare the efficacy and safety of LactiSal 1%vaginal gel and LactiSal 50 mg vaginal tablet with the standart treatment of clotrimazole 100 mg vaginal tablet in woman with vulvovaginal candidiasis (VVC)

Study Overview

• Status: Withdrawn
• Conditions: Vulvovaginal Candidiasis
• Intervention / Treatment: Device: LactiSal vaginal gel 1%; Device: LactiSal vaginal tablet 50mg; Drug: Clotrimazole vaginal tablet 100mg

Detailed Description

National multicenter,randomized, open-label, active-controlled with three parallel groups.Eligible patients are randomized to receive LactiSal 1% vaginal gel, LactiSal 50 mg vaginal tablet or clotrimazole 100 mg vaginal tablet for 6 days. Control examaminations are performed 10 after entry and 4 weeks after control visit 1.

The study investigates the clinical efficacy and safety of Lactisal 1% vaginal gel and LactiSal 50mg vaginal tablets in the intended use, i.e. vaginal application, and the following intended claims:

• Treatment of vaginal yeast vaginitis
• Relieves vaginal itching, burning, redness and discharge in case of yeast vaginitis
• Inhibition of yeast colonization in the vagina in case of yeast vaginitis. The study is designed to compare the clinical efficacy and safety of Lactisal 1% vaginal gel and LactiSal 50 mg vaginal tablets to a current standard drug therapy, i.e. clotrimazole 100 mg vaginal tablets.

While LactiSal is classified as medical device class IIa, the comparator is a medicinal (pharmaceutical) product. The study represents a "mixed" study, comparing the efficacy of a medical device with a pharmaceutical product.

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Clinical signs & symptoms of VVC as Total Severity Score, TSC 4 (range 0-15):

   • vaginal itching (range 0-3) ,
   • vaginal burning or soreness (range 0-3),
   • abnormal vaginal discharge (range 0-3),
   • vulvo/vaginal erythema or oedema (range 0-3),
   • vulvar excoriation or fissure formation (range 0-3).
2. Direct microscopy (Wet smear) positive for yeast forms (hyphae, pseudohyphae) or budding yeasts
3. Normal vaginal pH (≤4.5)
4. Age: 18 years and older
5. Signed Written Informed Consent to participate in this study.

Exclusion Criteria:

• Recurrent VVC (4 episodes of VVC in the past 12 months).
• Women with other vaginal infections, e.g. bacterial vaginosis, aerobic vaginitis, trichomoniasis, and mixed infections.
• Women using oral or vaginal antifungals within 2 weeks prior to enrolment.
• Women using any intra-vaginal products, also vaginal douches containing soaps and other anionic, surface-active substances, within 2 weeks prior to enrolment.
• Women using any antibiotic or anti-infective within 2 weeks prior to enrolment.
• Women having menstruation bleeding at enrolment
• Cervicitis, cervical erosions, and malignant tumours in the genital tract
• Pregnancy or lactation.
• Women not consenting to be sexually abstinent during the treatment, not taking oral contraceptive or not having an IUD for contraception
• Woman using intravaginal pessaries, rings, sponges or diaphragms
• Severe systemic diseases (diabetes mellitus, cancer, tuberculosis, autoimmune diseases, severe psychiatric conditions, etc.).
• Women with confirmed or suspected STD (HIV infection, gonorrhoea, syphilis, chlamydiasis, etc.).
• Known or suspected hypersensitivity to one of the study medications, inclusive their excipients.
• Participation of patient in another clinical study concomitantly or within 30 days prior to enrolment
• Patient is relative of, or staff directly reporting to, the investigator.

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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LactiSal vaginal gel 1%; 5g of 1%LactiSal Gel vaginal gel once daily for 6 days	Device: LactiSal vaginal gel 1%; to be administered daily intravaginally for 6 days
Experimental: LactiSal vaginal tablet 50 mg; 50 mg of LactiSal vaginal tablet daily for 6 days	Device: LactiSal vaginal tablet 50mg; to be administered daily intravaginally for 6 days
Active Comparator: Clotrimazole vaginal tablet 100mg; 100 mg Clotrimazole vaginal tablet daily for 6 days	Drug: Clotrimazole vaginal tablet 100mg; to be administered daily intravaginally for 6 days; Other Names: Candibene

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical cure rate	Clinical cure is defined as patient having a Total Severity Score of less than 3. The Total Severity Score (TSC) is assessed by the Investigator, examining and interviewing the patient. The TSC is the sum score of the 5 individual signs symptoms - vaginal itching, vaginal burning or soreness, abnormal vaginal discharge, vulvovaginal erythema or oedema and vulval excoriation or fissure formation. Each sign and symptom is assessed with a score from 0 to 3, resulting in total score for TSC of 0 to 15.	10 days after entry (C1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical cure rate	Clinical cure is defined as patient having a Total Severity Score of less than 3. The Total Severity Score (TSC) is assessed by the Investigator, examining and interviewing the patient. The TSC is the sum score of the 5 individual signs symptoms - vaginal itching, vaginal burning or soreness, abnormal vaginal discharge, vulvovaginal erythema or oedema and vulval excoriation or fissure formation. Each sign and symptom is assessed with a score from 0 to 3, resulting in total score for TSC of 0 to 15.	4 weeks after control visit 1
Microbiological cure rate	Negative for Candida in microscopy and culture	10 days after entry visit and 4 weeks after control visit 1
Therapeutic cure rate	Clinically and microbiologically cure combined	10 days after entry visit and 4 weeks after control visit 1
The Total Severity Score (TSC) Individual clinical signs and symptoms	The TCS assessed by the investigator; vaginal itching (range 0-3); vaginal burning or soreness (range 0-3); abnormal vaginal discharge (range 0-3); vulvo/vaginal erythema or oedema (range 0-3); vulvar excoriation or fissure formation (range 0-3)	10 days after entry visit and 4 weeks after control visit 1
Dyspareunia and external dysuria	Presence of dyspareunia and external dysuria (yes/no)	10 days after entry visit and 4 weeks after control visit 1
Direct microscopy (Wet smear)	Number of positive findings in Direct microscopy (Wet smear) in comparison to visit E	10 days after entry visit and 4 weeks after control visit 1
pH	Mean vaginal pH in comparison to visit E	10 days after entry visit and 4 weeks after control visit 1
Candida culture	Number of positive Candida cultures in comparison to visit E	10 days after entry visit and 4 weeks after control visit 1
Efficacy assessment	Global assessment of efficacy by patient and investigator	10 days after entry visit and 4 weeks after control visit 1
Patients diary	Assessment clinical symptoms from patient?s diary	10 days after entry visit and 4 weeks after control visit 1
Patient's satisfaction	Patient will be asked how satisfied she was with the treatment received based on 8 standardized questions.	10 days after entry visit and 4 weeks after control visit 1

Collaborators and Investigators

• Sponsor: Medinova AG
• Investigators: Principal Investigator: Michael Halaška, MD, Nemocnice Bulovka, 1. LF UK

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: September 23, 2015
• First Submitted That Met QC Criteria: September 14, 2016
• First Posted (Estimate): September 20, 2016

Study Record Updates

• Last Update Posted (Actual): March 8, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: LactiSal; Vaginal therapy
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Vulvovaginitis; Candidiasis; Candidiasis, Vulvovaginal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Clotrimazole; Miconazole
• Other Study ID Numbers: LacS011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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