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

Vulvovaginal Candidiasis Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02907307
• Other study ID #: LacS011
• Status: Withdrawn
• Phase: Phase 3
• Start date: December 2018
• Est. completion date: July 2020

Study information

• Verified date: December 2017
• Source: Medinova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Vulvovaginal Candidiasis

Intervention

Device:
• LactiSal vaginal gel 1%
to be administered daily intravaginally for 6 days
• LactiSal vaginal tablet 50mg
to be administered daily intravaginally for 6 days

Drug:
• Clotrimazole vaginal tablet 100mg
to be administered daily intravaginally for 6 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medinova AG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Microbiological cure rate	Negative for Candida in microscopy and culture	10 days after entry visit and 4 weeks after control visit 1
Secondary	Therapeutic cure rate	Clinically and microbiologically cure combined	10 days after entry visit and 4 weeks after control visit 1
Secondary	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
Secondary	Dyspareunia and external dysuria	Presence of dyspareunia and external dysuria (yes/no)	10 days after entry visit and 4 weeks after control visit 1
Secondary	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
Secondary	pH	Mean vaginal pH in comparison to visit E	10 days after entry visit and 4 weeks after control visit 1
Secondary	Candida culture	Number of positive Candida cultures in comparison to visit E	10 days after entry visit and 4 weeks after control visit 1
Secondary	Efficacy assessment	Global assessment of efficacy by patient and investigator	10 days after entry visit and 4 weeks after control visit 1
Secondary	Patients diary	Assessment clinical symptoms from patient?s diary	10 days after entry visit and 4 weeks after control visit 1
Secondary	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