A double-blind, randomised, dose-finding trial to assess the efficacy, safety and pharmacokinetics of a single dose of albaconazole versus fluconazole and placebo in the treatment of acute Candida vulvovaginitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Palau Pharma S.L.

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

18 Sep 2023 → 28 Oct 2025

Decision date (initial)

2024-09-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

PALAU PHARMA S.L.U.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Efficacy

To assess the efficacy of albaconazole (XX, YY or ZZ) compared to placebo with respect to clinical cure in subjects with acute Candida vulvovaginitis.

Conditions and MedDRA coding

Acute vulvovaginal candidiasis

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, The Spanish Agency Of Medicines And Medical Devices

EMA paediatric investigation plan (PIP)

EMEA-003279-PIP01-22

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Female post-menarche subjects
2. 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.
3. 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.
4. 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 7

1. Pregnant or lactating subjects.
2. Wish of pregnancy within 4 weeks following treatment.
3. Recurrent Candida vulvovaginitis (4 or more confirmed episodes of Candida spp. vaginal infection over the last 12 months prior to Visit 1).
4. Other active vulvovaginal infection (e.g., bacterial vaginosis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex or the human papilloma virus) or mixed infections.
5. Subjects with any other vaginal or vulvar condition which may confound the interpretation of the clinical response to treatment.
6. 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.
7. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage of subjects with clinical cure defined as vulvovaginal score sum = 0 at the Final Visit (FV) by treatment group (albaconazole vs. placebo).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Comparator 1

Placebo 2

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Palau Pharma S.L.

Sponsor organisation

Palau Pharma S.L.

Address

Avinguda Del Cami Reial 51-57

City

Palau-Solita I Plegamans

Postcode

08184

Country

Spain

Scientific contact point

Organisation

Palau Pharma S.L.

Contact name

Scientific Information Desk

Public contact point

Organisation

Palau Pharma S.L.

Contact name

DCALB Information Desk

Third parties 11

Locations

2 EU/EEA countries · 26 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 44 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

10 submissions — initial application plus substantial / non-substantial modifications