Comparative Efficacy Study of 10 mg Dequalinium Chloride (Fluomizin) in the Treatment of Vulvovaginal Candidiasis

Vulvovaginal Candidiasis Clinical Trial

Official title:

Comparative Study of the Efficacy of 10.0 mg Dequalinium Chloride (Fluomizin®) and 100 mg Clotrimazole (Canesten®) for the Treatment of Vulvovaginal Candidiasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02242695
• Other study ID #: Flu-380112
• Status: Completed
• Phase: Phase 4
• First received: October 23, 2013
• Last updated: September 14, 2016
• Start date: November 2014
• Est. completion date: April 2016

Study information

• Verified date: July 2015
• Source: Medinova AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A clinical study to compare the clinical efficacy of vaginal tablets containing 10mg dequalinium chloride (Fluomizin) with the clinical efficacy of 100mg clotrimazole in patients suffering from vulvovaginal candidiasis, to assess safety of the two medications during the treatment, and to evaluate women's satisfaction with the two treatments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Clinical signs and symptoms of vulvovaginal candididiasis as Total Severity Score, Total Severity Score of at least 4 (0-15: vaginal itching (0-3), vaginal burning or soreness (0-3), abnormal vaginal discharge (0-3),vulvo/vaginal erythema or edema(0-3), vulvar excoriation or fissure formation (0-3).

• Direct microscopy (Wet smear) positive for yeast forms (hyphae/pseudohyphae) or budding yeasts.

• normal vaginal pH (higher than 4.5) at baseline.

• Women aged 18 - 45 years old.

• Women can comply with all clinical trial instructions, and can return to all follow-up visits.

• Signed Written Informed Consent to participate in this study.

Exclusion Criteria:

• Recurrent vulvovaginal candidiasis(4 episodes of VVC in the last 12 months).

• Women with other cause of vaginal infections, e.g. bacterial vaginosis, aerobic vaginitis, trichomoniasis, and mixed infections

• Women using oral or vaginal antifungals within 2 weeks prior to enrolment and during the study.

• Women using any intra-vaginal products, also vaginal douches containing soaps and other anionic, surface-active substances, within 2 weeks prior to enrolment and during the study.

• Women using any antibiotic or anti-infective within 2 weeks prior to enrolment.

• Cervicitis, abnormal PAP smear in the last 6 month.

• Severe systemic diseases (HIV infection, diabetes mellitus, cancer, tuberculosis, autoimmune diseases, severe psychiatric conditions, etc.).

• Women with confirmed Neisseria gonorrhoea or Chlamydia trachomatis.

• Women having menstruation bleeding at enrolment.

• Known or suspected hypersensitivity to one of the study medications, inclusive their excipients.

• Participation of patient in another investigational drug study concomitantly or within 30 days prior to entry in the study.

• Patient is relative of, or staff directly reporting to, the investigator.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Vulvovaginal Candidiasis

Intervention

Drug:
• Fluomizin vaginal tablets
One vaginal tablet for 6 days and 1 placebo tablet on day 7
• Canesten vaginal tablets
one vaginal tablet for 7 days

Locations

Country	Name	City	State
Thailand	Siriraj Gynaecologic ID and Female STD Unit, Department of Obstetrics & Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok	Bangkok Noi district

Sponsors (2)

Lead Sponsor	Collaborator
Medinova AG	Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical cure rate	Clinical cure rate is defined as Total Severity Score (TSC) = 2	Control 1 at day 4 after therapy end	No
Secondary	Microbiological cure rate	Negative microscopy for showing yeast forms (hyphae/pseudohyphae) or budding yeasts and Negative Candida culture	Control 1 at 4 days after therapy end	No
Secondary	Therapeutic cure rate	Clinically and microbiologically cured	Control 1 at 4 days after therapy end	No
Secondary	Individual clinical signs and symptoms	4-point rating scale for vaginal itching, vaginal burning or soreness, vulvo/vaginal erythema or edema, and vulvar excoriation ofr fissure formation	Control 1 at 4 days after therapy end	No
Secondary	Presence of dyspareunia	yes/no	Control 1 at 4 days after therapy end	No
Secondary	Direct microscopy (wet smear)	Presence or absence of Candida hyphea or spores	Control 1 at 4 days after therapy end	No
Secondary	vaginal pH		Control 1 at 4 days after therapy end	No
Secondary	Candida culture	positive / negative for Candida spp	Control 1 at 4 days after therapy end	No
Secondary	Global assessment of efficacy	4-point rating scale assessed by investigator and patient	Control 1 at 4 days after therapy end	No
Secondary	Patient Satisfaction	presence of vaginal discomfort, increased discharge, burning sensation	Control 1 at 4 days after therapy end	No
Secondary	Adverse event	Number of participants experiencing an adverse event	Control 1 at 4 days after therapy end	Yes
Secondary	Global assessment of tolerability	4-point rating scale by investigator and patient	Control 1 at 4 days after therapy end	Yes
Secondary	Clinical cure rate	Clinical cure rate defined as Total Symptom Score TSC = 2	Control 2 at 6 weeks after therapy end	No
Secondary	Presence of external dysuria	yes/no	Control 1 at 4 days after therapy end	No
Secondary	Microbiological cure rate	Negative microscopy for showing yeast forms (hyphae/pseudohyphae) or budding yeasts and Negative Candida culture	Control 2 at 6 weeks after therapy end	No
Secondary	Therapeutic cure rate	Clinically and microbiologically cured	Control 2 at 6 weeks after therapy end	No
Secondary	Individual clinical signs and symptoms	4-point rating scale for vaginal itching, vaginal burning or soreness, vulvo/vaginal erythema or edema, and vulvar excoriation ofr fissure formation	Control 2 at 6 weeks after therapy end	No
Secondary	Presence of dyspareunia	yes/no	Control 2 at 6 weeks after therapy end	No
Secondary	Direct microscopy (wet smear)	Presence or absence of Candida hyphea or spores	Control 2 at 6 weeks after therapy end	No
Secondary	vaginal pH		Control 2 at 6 weeks after therapy end	No
Secondary	Candida culture	positive / negative for Candida spp	Control 2 at 6 weeks after therapy end	No
Secondary	Global assessment of efficacy	4-point rating scale assessed by investigator and patient	Control 2 at 6 weeks after therapy end	No
Secondary	Patient Satisfaction	presence of vaginal discomfort, increased discharge, burning sensation	Control 2 at 6 weeks after therapy end	No
Secondary	Adverse event	Number of participants experiencing an adverse event	Control 2 at 6 weeks after therapy end	Yes
Secondary	Global assessment of tolerability	4-point rating scale by investigator and patient	Control 2 at 6 weeks after therapy end	Yes
Secondary	Presence of external dysuria	yes/no	Control 2 at 6 weeks after therapy end	No