Clinical trial NCT02242695: Comparative Efficacy Study of 10 mg Dequalinium Chloride (Fluomizin) in the Treatment of Vulvovaginal Candidiasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vulvovaginal Candidiasis
Keywords: vulvovaginal candidiasis
vulvovaginal candidosis
mycotic vaginal infection
dequalinium chloride
Fluomizin
clotrimazole
canesten
Lead sponsor: Medinova AG
Sponsor class: INDUSTRY
Collaborators: name: Mahidol University
First posted: 2014-09-17
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical cure rate
timeFrame: Control 1 at day 4 after therapy end
Secondary outcomes:
measure: Microbiological cure rate
timeFrame: Control 1 at 4 days after therapy end
measure: Therapeutic cure rate
timeFrame: Control 1 at 4 days after therapy end
measure: Individual clinical signs and symptoms
timeFrame: Control 1 at 4 days after therapy end
measure: Presence of dyspareunia
timeFrame: Control 1 at 4 days after therapy end
measure: Direct microscopy (wet smear)
timeFrame: Control 1 at 4 days after therapy end
measure: vaginal pH
timeFrame: Control 1 at 4 days after therapy end
measure: Candida culture
timeFrame: Control 1 at 4 days after therapy end
measure: Global assessment of efficacy
timeFrame: Control 1 at 4 days after therapy end
measure: Patient Satisfaction
timeFrame: Control 1 at 4 days after therapy end
measure: Adverse event
timeFrame: Control 1 at 4 days after therapy end
measure: Global assessment of tolerability
timeFrame: Control 1 at 4 days after therapy end
measure: Clinical cure rate
timeFrame: Control 2 at 6 weeks after therapy end
measure: Presence of external dysuria
timeFrame: Control 1 at 4 days after therapy end
measure: Microbiological cure rate
timeFrame: Control 2 at 6 weeks after therapy end
measure: Therapeutic cure rate
timeFrame: Control 2 at 6 weeks after therapy end
measure: Individual clinical signs and symptoms
timeFrame: Control 2 at 6 weeks after therapy end
measure: Presence of dyspareunia
timeFrame: Control 2 at 6 weeks after therapy end
measure: Direct microscopy (wet smear)
timeFrame: Control 2 at 6 weeks after therapy end
measure: vaginal pH
timeFrame: Control 2 at 6 weeks after therapy end
measure: Candida culture
timeFrame: Control 2 at 6 weeks after therapy end
measure: Global assessment of efficacy
timeFrame: Control 2 at 6 weeks after therapy end
measure: Patient Satisfaction
timeFrame: Control 2 at 6 weeks after therapy end
measure: Adverse event
timeFrame: Control 2 at 6 weeks after therapy end
measure: Global assessment of tolerability
timeFrame: Control 2 at 6 weeks after therapy end
measure: Presence of external dysuria
timeFrame: Control 2 at 6 weeks after therapy end
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Gynaecologic ID and Female STD Unit, Department of Obstetrics & Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University
state: Bangkok Noi district
Study officials:
affiliation: Siriraj Gynaecologic ID and Female STD Unit, Mahidol University
name: Manopchai Thamkhantho, Prof MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thamkhantho M, Chayachinda C. Vaginal tablets of dequalinium chloride 10 mg versus clotrimazole 100 mg for vaginal candidiasis: a double-blind, randomized study. Arch Gynecol Obstet. 2021 Jan;303(1):151-160. doi: 10.1007/s00404-020-05784-z. Epub 2020 Sep 17.