Vulvovaginal Candidiasis
Conditions
Keywords
vulvovaginal candidiasis, vulvovaginal candidosis, mycotic vaginal infection, dequalinium chloride, Fluomizin, clotrimazole, canesten
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.
Interventions
DRUGFluomizin vaginal tablets
One vaginal tablet for 6 days and 1 placebo tablet on day 7
DRUGCanesten vaginal tablets
one vaginal tablet for 7 days
Sponsors
Mahidol University
Medinova AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical cure rate | Control 1 at day 4 after therapy end | Clinical cure rate is defined as Total Severity Score (TSC) ≤ 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global assessment of efficacy | Control 1 at 4 days after therapy end | 4-point rating scale assessed by investigator and patient |
| Patient Satisfaction | Control 1 at 4 days after therapy end | presence of vaginal discomfort, increased discharge, burning sensation |
| Microbiological cure rate | Control 1 at 4 days after therapy end | Negative microscopy for showing yeast forms (hyphae/pseudohyphae) or budding yeasts and Negative Candida culture |
| Therapeutic cure rate | Control 1 at 4 days after therapy end | Clinically and microbiologically cured |
| Individual clinical signs and symptoms | Control 1 at 4 days after therapy end | 4-point rating scale for vaginal itching, vaginal burning or soreness, vulvo/vaginal erythema or edema, and vulvar excoriation ofr fissure formation |
| Presence of dyspareunia | Control 1 at 4 days after therapy end | yes/no |
| Candida culture | Control 1 at 4 days after therapy end | positive / negative for Candida spp |
| vaginal pH | Control 1 at 4 days after therapy end | — |
| Adverse event | Control 1 at 4 days after therapy end | Number of participants experiencing an adverse event |
| Global assessment of tolerability | Control 1 at 4 days after therapy end | 4-point rating scale by investigator and patient |
| Clinical cure rate | Control 2 at 6 weeks after therapy end | Clinical cure rate defined as Total Symptom Score TSC ≤ 2 |
| Presence of external dysuria | Control 1 at 4 days after therapy end | yes/no |
| Direct microscopy (wet smear) | Control 1 at 4 days after therapy end | Presence or absence of Candida hyphea or spores |
Countries
Thailand
Outcome results
None listed