In short
Clinical trials are investigating Albaconazole in women with acute Candida vulvovaginitis, also called acute vulvovaginal candidiasis. The studies aim to evaluate how well it works, how safe it is, and how the body handles it. They also compare Albaconazole with fluconazole and placebo.
Key points
- Albaconazole is being studied in a completed Phase 2 trial for acute vulvovaginal candidiasis, a Candida yeast infection of the vagina and surrounding area. The study compares Albaconazole with fluconazole and placebo. It is a double-blind, randomised, dose-finding trial, so treatment assignment was planned by chance and kept hidden during the study. The main outcome is clinical cure, measured by a vulvovaginal score sum of 0 at the final visit. The trial enrolled 702 participants.
Trial overview
The available study of Albaconazole was designed to assess its efficacy, safety, and pharmacokinetics in acute Candida vulvovaginitis. Acute Candida vulvovaginitis is also called acute vulvovaginal candidiasis, which is a yeast infection affecting the vulva and vagina.
This was a Phase 2 study, which means it was a mid-stage clinical trial focused on learning more about whether the treatment works while still monitoring safety.
Study design and treatment groups
The trial was described as double-blind and randomised, meaning treatment groups were assigned by chance and neither the participants nor the study team knew who received which treatment during the study.
It was also a dose-finding trial, so the study aimed to assess different Albaconazole doses, listed as XX, YY, and ZZ in the source data, against comparison groups.
The study compared Albaconazole with fluconazole and placebo, and the source also lists placebo groups for both Albaconazole and fluconazole. A placebo is a look-alike treatment with no active medicine, used to help show whether the study drug has an effect beyond no active treatment.
Who could participate
The trial focused on subjects with acute vulvovaginal candidiasis. The source data do not provide more detailed inclusion or exclusion criteria, so the exact participation rules are not listed here.
The brief summary says the study was designed for subjects with acute Candida vulvovaginitis, which points to women with an active yeast infection in the vaginal area.
What was measured
The main outcome was the percentage of subjects with clinical cure at the Final Visit. In this trial, clinical cure was defined as a vulvovaginal score sum of 0, meaning no measured signs or symptoms remained at that visit.
The study also aimed to assess safety and pharmacokinetics. Pharmacokinetics means how the body absorbs, moves, breaks down, and removes a study drug.
Trial status and size
The study is listed as Completed. It enrolled 702 participants, which is a fairly large number for a single trial in this condition.
Only one trial record was provided in the source data, so this article summarizes that single Albaconazole study rather than a larger trial program.