Breast CancerNCT06392529
Efficacy of Voriconazole Loaded Spanlastics Gel Versus Clotriamazole Cream on Treating Vulvovaginal Candidasis
An observational study of Breast Cancer, run by Beni-Suef University at 1 site in Egypt.
Trial summary
To investigate and compare the efficacy of voriconazole loaded spanlastics (VCZ loaded SPs) optimum gel formula (F2 VCZ loaded SP gel) versus Clotrimazole cream in treating candida albicans causing vulvovaginal candidiasis for different durations of 3 days and 5 days. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Voriconazole Powder
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2024to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Adult
Study population: Female patients suffering from vulvovaginal candidiasis albicans
Who may be able to join
- Female patients aging from 20 t0 40 years old suffering from vulvovaginal candidiasis caused by albicans species.
Who cannot join
- Pregnant women, female suffering from vulvovaginal candidiasis caused by other species rather than C. albicans.
Trial locations and contacts
1 site in 1 country.
About this study
To investigate and compare the efficacy of voriconazole loaded spanlastics (VCZ loaded SPs) optimum gel formula (F2 VCZ loaded SP gel) versus Clotrimazole cream in treating candida albicans causing vulvovaginal candidiasis for different durations of 3 days and 5 days.
Read the detailed description
The current study will be prospective controlled randomized clinical trial. 28 female patients suffering from vulvovaginal candidiasis will be enrolled in the following 2 groups:
Gp 1 (Test group): including 14 patients with vulvovaginal candidiasis albicans that will be randomized in the following subgroups:
Gp 1a: will be treated with F2 VCZ loaded SP gel for 3 days. Gp 1 b: Will be treated with F2 VCZ loaded SP gel for 5 days. Gp 2 (Control group): including 14 patients with vulvovaginal candidiasis albicans will be randomized in the following sub groups Gp 2 a: will be treated with the Clotrimazole cream available in the market for 3 days.
Gp 2 b: Will be treated with the Clotrimazole cream available in the market for 5 days.
Smears will be taken from the patients before starting the therapeutic protocol and after finishing it. Compliance of the patients to the creams will be assesses
- Conditions
- Breast Cancer
- Being tested
- Voriconazole Powder
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voriconazole PowderDrug
The drug will be topically applied for vagina of patients suffering from vaginal Candidasis albican
| Study group | Role | What they receive |
|---|---|---|
| Voriconazole Group | Not described Receives: Drug: Voriconazole Powder | |
| Clotriamazole group | Not described Receives: Drug: Voriconazole Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of nano voriconazole versus Clotrimazole in Treatment of vaginal candidiasis albicans and removal of symptoms
To assess and compare the efficacy of nano voriconazole versus Clotrimazole in Treatment of vaginal candidiasis albicans in 3 and 5 days via smear cultures
Measured: 1Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start10 May 2024
- Primary completion15 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raghda R.S. Hussein, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392529
- Sponsor's protocol ID
- REC-H-PhBSU-24009
- Status last verified
- Aug 2024
- First submitted
- 26 Apr 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Voriconazole Loaded Spanlastics Gel Versus Clotriamazole Cream on Treating Vulvovaginal Candidasis
- ClinicalTrials.gov ID
- NCT06392529
- Acronym / sponsor ID
- REC-H-PhBSU-24009
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate and compare the efficacy of voriconazole loaded spanlastics (VCZ loaded SPs) optimum gel formula (F2 VCZ loaded SP gel) versus Clotrimazole cream in treating candida albicans causing vulvovaginal candidiasis for different durations of 3 days and 5 days.
Detailed description
The current study will be prospective controlled randomized clinical trial. 28 female patients suffering from vulvovaginal candidiasis will be enrolled in the following 2 groups:
Gp 1 (Test group): including 14 patients with vulvovaginal candidiasis albicans that will be randomized in the following subgroups:
Gp 1a: will be treated with F2 VCZ loaded SP gel for 3 days. Gp 1 b: Will be treated with F2 VCZ loaded SP gel for 5 days. Gp 2 (Control group): including 14 patients with vulvovaginal candidiasis albicans will be randomized in the following sub groups Gp 2 a: will be treated with the Clotrimazole cream available in the market for 3 days.
Gp 2 b: Will be treated with the Clotrimazole cream available in the market for 5 days.
Smears will be taken from the patients before starting the therapeutic protocol and after finishing it. Compliance of the patients to the creams will be assesses
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Voriconazole Group | – | Drug: Voriconazole Powder |
| Clotriamazole group | – | Drug: Voriconazole Powder |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Female patients suffering from vulvovaginal candidiasis albicans
Key inclusion criteria (1 listed)
- Female patients aging from 20 t0 40 years old suffering from vulvovaginal candidiasis caused by albicans species.
Key exclusion criteria (1 listed)
- Pregnant women, female suffering from vulvovaginal candidiasis caused by other species rather than C. albicans.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voriconazole PowderThe drug will be topically applied for vagina of patients suffering from vaginal Candidasis albican | Drug | Clotriamazole group, Voriconazole Group |
Primary outcome
efficacy of nano voriconazole versus Clotrimazole in Treatment of vaginal candidiasis albicans and removal of symptoms
Time frame: 1Month
To assess and compare the efficacy of nano voriconazole versus Clotrimazole in Treatment of vaginal candidiasis albicans in 3 and 5 days via smear cultures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of nano voriconazole versus Clotrimazole in Treatment of vaginal candidiasis albicans and removal of symptoms (time frame: 1Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.