Efficacy, Safety, and Pharmacokinetics of Single-Dose Albaconazole Versus Fluconazole and Placebo in Acute Vulvovaginal Candidiasis
- Trial ID
- 2023-504727-32-00
- Protocol
- DC13ALB/2/21
- Sponsor
- Palau Pharma S.L.
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the **efficacy** of different single doses of **albaconazole** compared to placebo in achieving clinical cure in subjects with acute **vulvovaginal candidiasis**. This is clinically relevant as it aims to determine the optimal dosing of albaconazole, potentially offering an effective treatment alternative for this common fungal infection. The study also involves comparisons with **fluconazole**, a standard treatment, to assess the relative efficacy and safety of albaconazole.
Participants
The clinical trial focuses on evaluating the efficacy of different single doses of albaconazole compared to placebo in achieving clinical cure for **acute vulvovaginal candidiasis**. The study population comprises exclusively female participants, specifically post-menarche individuals, including adolescents younger than 18 years of age. The age range of participants spans from adolescents to adults, as indicated by the age range categories provided. Participants were selected based on a confirmed diagnosis of acute Candida vulvovaginitis, characterized by specific signs and symptoms, a positive rapid antigen test for Candida spp., and a vaginal pH of 4.4 or lower. The trial includes a vulnerable population, and all participants provided informed consent, with additional assent and parental consent required for minors. The sponsor has not provided information regarding the total number of participants. Participants are required to adhere to highly effective birth control methods if they are of childbearing potential. The trial does not include male subjects, and no specific lifestyle considerations such as diet or physical activity are mentioned.
Plans and Procedures
The clinical trial is designed as a **randomized**, **double-blind**, controlled study to evaluate the efficacy, safety, and pharmacokinetics of a single dose of **albaconazole** compared to **fluconazole** and placebo in the treatment of acute vulvovaginal candidiasis. The trial is categorized as a Phase 4 study and is expected to involve approximately 252 participants. The trial is scheduled to commence recruitment on September 1, 2023, and is anticipated to conclude by April 30, 2025. Participants will be randomly assigned to receive either albaconazole, fluconazole, or a placebo, with the primary endpoint being the percentage of subjects achieving clinical cure, defined as a vulvovaginal score sum of zero at the final visit.
The study will include several key visits: an initial screening visit, follow-up visits, and an end-of-study visit. During the screening visit, eligibility will be confirmed based on the presence of acute vulvovaginal candidiasis symptoms, a positive rapid antigen test for **Candida spp.**, and a vaginal pH of 4.4 or lower. Participants must provide informed consent, and those of childbearing potential must adhere to effective birth control methods. Follow-up visits will monitor the participants' response to treatment and any adverse events. The end-of-study visit will assess the final clinical outcomes and gather data for the primary endpoint analysis.
Participant involvement is expected to last for the duration of the treatment period, which is a single dose administration, followed by the necessary follow-up visits. Conditions that may lead to early termination from the study include non-compliance with the study protocol, withdrawal of consent, or the occurrence of significant adverse events. The trial aims to provide valuable insights into the comparative effectiveness of albaconazole in treating acute vulvovaginal candidiasis, contributing to the optimization of therapeutic strategies for this condition.
Treatment
The clinical trial involves the administration of **Albaconazole**, a chemical compound provided in the form of a hard capsule. The pharmaceutical product is manufactured by Palau Pharma S.L.U. and is identified by the European Medicinal Product number PRD10362281. The active substance, albaconazole, is administered orally. The trial aims to evaluate the efficacy of different single doses of albaconazole, although specific dosages (XX, YY, or ZZ) are not detailed in the provided data. The maximum treatment period for albaconazole is one day, and the trial does not specify a maximum daily dose amount.
In addition to albaconazole, the trial includes a **placebo** group. The placebo is designed to mimic the albaconazole capsule but does not contain any active pharmaceutical ingredient. The placebo serves as a control to assess the efficacy of albaconazole in treating acute Candida vulvovaginitis. The placebo is administered orally, consistent with the administration route of the active treatment.
The trial also involves the use of **Diflucan**, a commercially available formulation of **Fluconazole**. This product is provided in hard capsule form, with a dosage of 150 mg per capsule. Fluconazole is a well-established antifungal agent, and in this trial, it serves as a comparator to evaluate the efficacy of albaconazole. The product is manufactured by Vincifarma S.A. and is administered orally. The maximum treatment period for fluconazole is one day, with no specified maximum daily dose amount.
Additionally, the trial includes the use of **CANADIOL**, a formulation of **Itraconazole** provided in capsule form. Each capsule contains 100 mg of itraconazole, and the product is manufactured by Esteve Pharmaceuticals, S.A. Itraconazole is administered orally, with a maximum daily dose of 400 mg and a total maximum dose of 600 mg over a treatment period of up to three days. This product serves as an auxiliary treatment in the trial.
Efficacy
The efficacy of the clinical trial will be assessed by evaluating the primary endpoint, which is the percentage of subjects achieving a clinical cure. Clinical cure is defined as a vulvovaginal score sum of 0 at the Final Visit (FV) by treatment group, comparing **albaconazole** to placebo. The trial is designed to assess the efficacy, safety, and pharmacokinetics of a single dose of albaconazole versus fluconazole and placebo in the treatment of acute Candida vulvovaginitis. The trial will involve approximately 252 patients and is categorized as a phase IIb study.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Female post-menarche subjects
- Diagnosed with acute Candida vulvovaginitis according to the following criteria: a. Two or more of the signs and symptoms of Candida vulvovaginitis (itching, burning, irritation, oedema, redness, or excoriation), with at least one with moderate intensity of vulvovaginal signs and symptoms Grade of symptoms is defined as follows: 0 = absent, 1 = mild, 2 = moderate, 3 = severe. b. Rapid antigen test positive for Candida spp. c. Vaginal pH ≤ 4.4 The diagnosis must be confirmed by a positive Candida spp. culture. Swabs for the culture have to be taken before the intake of IP.
- Written informed consent/assent given freely after the nature of the trial and disclosure of data has been explained to the subject. In the case of adolescents (post-menarche women younger than 18 years of age at enrolment), assent by the subject must be given as well as consent from parent/legal representative, according to local legislation.
- For females of childbearing potential only: must use highly effective methods of birth control, e.g. male or female condoms, diaphragms, combined hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence (if defined as refraining from heterosexual intercourse during the entire period of risk associated with the trial treatment). For barrier methods as male condoms, female condoms and diaphragms it is recommended to use 2 methods of birth control.
Exclusion Criteria
- Pregnant or lactating subjects.
- Wish of pregnancy within 4 weeks following treatment.
- Recurrent Candida vulvovaginitis (4 or more confirmed episodes of Candida spp. vaginal infection over the last 12 months prior to Visit 1).
- Other active vulvovaginal infection (e.g., bacterial vaginosis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex or the human papilloma virus) or mixed infections.
- Subjects with any other vaginal or vulvar condition which may confound the interpretation of the clinical response to treatment.
- Known contraindications/hypersensitivity to the trial medication, any of the excipients of the trial medication (protocol Section 10.1 and 10.2) or to azole derivatives.
- Prior treatment with topical vaginal or vulvar antifungal agents within the last 7 days prior to Visit 1 or with systemic antifungal agents within the last 28 days prior to Visit 1.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Poland | Not Recruiting | 01 Sept 2023 | 334 |
 Spain | Not Recruiting | 01 Sept 2023 | 368 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Diflucan 150 mg cápsulas duras. | Comparator | CÁPSULAS DURAS | ORAL USE | 00 | 1 | PRD467857 |
Albaconazole | Test | CAPSULE, HARD | ORAL USE | 00 | 1 | PRD10342914 |
Albaconazole | Test | CAPSULE, HARD | ORAL USE | 00 | 1 | PRD10362280 |
Albaconazole | Test | CAPSULE, HARD | ORAL USE | 00 | 1 | PRD10362281 |
Placebo - Albaconazole | Placebo | N/A | — | — | — | N/A |
Placebo - Fluconazole | Placebo | N/A | — | — | — | N/A |
CANADIOL 100 mg cápsulas | Other | CÁPSULAS | ORAL USE | 400 | 3 | PRD542802 |