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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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 Vulvovagina

Brief 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)

Detailed Summary:

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.


Sponsor: Medinova AG

Current Primary Outcome: Clinical cure rate [ Time Frame: 10 days after entry (C1) ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical cure rate [ Time Frame: 4 weeks after control visit 1 ]
    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.
  • Microbiological cure rate [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]
    Negative for Candida in microscopy and culture
  • Therapeutic cure rate [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]
    Clinically and microbiologically cure combined
  • The Total Severity Score (TSC) Individual clinical signs and symptoms [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]

    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)
  • Dyspareunia and external dysuria [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]
    Presence of dyspareunia and external dysuria (yes/no)
  • Direct microscopy (Wet smear) [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]
    Number of positive findings in Direct microscopy (Wet smear) in comparison to visit E
  • pH [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]
    Mean vaginal pH in comparison to visit E
  • Candida culture [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]
    Number of positive Candida cultures in comparison to visit E
  • Efficacy assessment [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]
    Global assessment of efficacy by patient and investigator
  • Patients diary [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]
    Assessment clinical symptoms from patient?s diary
  • Patient's satisfaction [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]
    Patient will be asked how satisfied she was with the treatment received based on 8 standardized questions.


Original Secondary Outcome: Same as current

Information By: Medinova AG

Dates:
Date Received: September 23, 2015
Date Started: May 2017
Date Completion: July 2018
Last Updated: September 14, 2016
Last Verified: September 2016