Recurrent Vulvovaginal CandidiasisNCT05795491
Blue Light Emitting Diode Therapy on Vulvovaginal Candidiasis
A study testing Blue Light Emitting Diode Therapy and Azole Antifungal in people with Recurrent Vulvovaginal Candidiasis, run by Cairo University at 1 site in Egypt.
Trial summary
With the knowledge that VVC is an infectious disease of the genitourinary tract that is common in women of reproductive age, and because of the shortage of non-drug therapies for this condition, this study will aim to evaluate the effect of ultraviolet A/blue LED with a wavelength of 401 ± 5 nm in patients with a… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Recurrent Vulvovaginal Candidiasis
- What is being tested?
- Blue Light Emitting Diode Therapy and Azole Antifungal
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 1 Jun 2023
- Phase
- Interventional
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- subject selection will be according to the following criteria:
- Age will range between 18- 50 years.
- All patients will be confirmed by culture and examination of fresh vaginal samples, to have VVC.
- All patients who will be enrolled to the study will have their informed consent.
Who cannot join
- The participants will be excluded if they meet one of the following criteria:
- Individuals on any other antifungal drugs.
- Individuals with cardiopulmonary conditions.
- Individuals undergoing another radiation therapy.
- Sensory impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Blue Light Emitting Diode Therapy on Recurrent Vulvovaginal Candidiasis
With the knowledge that VVC is an infectious disease of the genitourinary tract that is common in women of reproductive age, and because of the shortage of non-drug therapies for this condition, this study will aim to evaluate the effect of ultraviolet A/blue LED with a wavelength of 401 ± 5 nm in patients with a clinical manifestation of candidiasis and its ability to prevent recurrence.
Read the detailed description
Vulvovaginal candidiasis (VVC) is an infection of the vulva and vagina caused by the abnormal growth of several Candida species. This pathology is one of the most common diagnoses in gynecological practice and the second most common genital infection. Studies have shown that 15 to 25% of adult women present with fungal colonization despite being asymptomatic and that 75% of them will develop the disease at some point in their lives.
The treatment of VVC involves the use of antifungal agents, either orally or topically, which resolves 80 to 90% of the cases. However, the use of these agents can lead to the development of adverse reactions such as dysuria, pruritus, and gastrointestinal disorders.
Accordingly, a hypothesis arises that the blue/violet light- emitting diode (LED) may be an alternative treatment for women with VVC because of its antimicrobial effect that has been proven by several studies. Moreover, it is considered a safe, non-invasive, painless, and non-toxic technique for use in several types of tissue.
- Conditions
- Recurrent Vulvovaginal Candidiasis
- Being tested
- Blue Light Emitting Diode Therapy, Azole Antifungal
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue Light Emitting Diode TherapyDevice
Also called Blue LED
Light-emitting diode (LEDs) as a preferred light source for phototherapy is a semiconductor device that, through the process of electroluminescence, generates light emitted at different wavelengths, causing a differentiation in color and effects.
Azole AntifungalDrug
Also called fluconazole
Azole antifungals are a group of medicines that contain an azole ring and inhibit the growth of a wide range of fungi
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | This group includes 30 patients will receive routine medical treatment with antifungal, azole (vaginal route).
100 ml ( one Suppository ) at bedtime for three nights in a row Receives: Drug: Azole Antifungal |
| Group B | Experimental | This group includes 30 patients. The vulva and vagina will be exposed to 401 ± 5 nm ultraviolet A/ blue LED irradiation in a single session, divided into two applications. Receives: Device: Blue Light Emitting Diode Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal swab culture .
It will be taken before and after the treatment and after one month for assessment of recurrence, by using a potassium hydroxide (KOH) test and fresh cytology with saline solution will be used to analyze the composition of the vaginal discharge under optical microscope
Measured: 2 months
Secondary outcomes (1)
Litmus Paper
•Litmus paper for measuring vaginal PH before and after treatment and after one month of recurrence. A vaginal pH test measures the acidity of the vagina on a scale of 1-14, by holding a piece of pH paper against the wall of your vagina for a few seconds, then compare the color of the pH paper to the color on the chart provided with the test kit. The number on the chart for the color that best matches the color on the pH paper is the vaginal pH number.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Apr 2023
- Primary completion1 May 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Vulvovaginal CandidiasisStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Mohamed Reda Shalaby, Cairo University
- Investigators
- Soheir El-kosery, PHD, Principal investigator, Professor of physical Therapy, Faculty of Physical therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795491
- Sponsor's protocol ID
- 012/004261
- Status last verified
- May 2024
- First submitted
- 21 Mar 2023
- Last updated
- 2 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: All Data including assessment measures, treatment and results
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Blue Light Emitting Diode Therapy on Recurrent Vulvovaginal Candidiasis
- ClinicalTrials.gov ID
- NCT05795491
- Acronym / sponsor ID
- 012/004261
- Conditions
- Recurrent Vulvovaginal Candidiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 3 Apr 2023 (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.
With the knowledge that VVC is an infectious disease of the genitourinary tract that is common in women of reproductive age, and because of the shortage of non-drug therapies for this condition, this study will aim to evaluate the effect of ultraviolet A/blue LED with a wavelength of 401 ± 5 nm in patients with a clinical manifestation of candidiasis and its ability to prevent recurrence.
Detailed description
Vulvovaginal candidiasis (VVC) is an infection of the vulva and vagina caused by the abnormal growth of several Candida species. This pathology is one of the most common diagnoses in gynecological practice and the second most common genital infection. Studies have shown that 15 to 25% of adult women present with fungal colonization despite being asymptomatic and that 75% of them will develop the disease at some point in their lives.
The treatment of VVC involves the use of antifungal agents, either orally or topically, which resolves 80 to 90% of the cases. However, the use of these agents can lead to the development of adverse reactions such as dysuria, pruritus, and gastrointestinal disorders.
Accordingly, a hypothesis arises that the blue/violet light- emitting diode (LED) may be an alternative treatment for women with VVC because of its antimicrobial effect that has been proven by several studies. Moreover, it is considered a safe, non-invasive, painless, and non-toxic technique for use in several types of tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Drug: Azole AntifungalThis group includes 30 patients will receive routine medical treatment with antifungal, azole (vaginal route). 100 ml ( one Suppository ) at bedtime for three nights in a row |
| Group B | Experimental | Device: Blue Light Emitting Diode TherapyThis group includes 30 patients. The vulva and vagina will be exposed to 401 ± 5 nm ultraviolet A/ blue LED irradiation in a single session, divided into two applications. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age will range between 18- 50 years.
- All patients will be confirmed by culture and examination of fresh vaginal samples, to have VVC.
- All patients who will be enrolled to the study will have their informed consent.
Key exclusion criteria (5 listed)
- Individuals on any other antifungal drugs.
- Individuals with cardiopulmonary conditions.
- Individuals undergoing another radiation therapy.
- Sensory impairment
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 |
|---|---|---|
| Blue Light Emitting Diode TherapyAlso: Blue LEDLight-emitting diode (LEDs) as a preferred light source for phototherapy is a semiconductor device that, through the process of electroluminescence, generates light emitted at different wavelengths, causing a differentiation in color and effects. | Device | Group B |
| Azole AntifungalAlso: fluconazoleAzole antifungals are a group of medicines that contain an azole ring and inhibit the growth of a wide range of fungi | Drug | Group A |
Primary outcome
Vaginal swab culture .
Time frame: 2 months
It will be taken before and after the treatment and after one month for assessment of recurrence, by using a potassium hydroxide (KOH) test and fresh cytology with saline solution will be used to analyze the composition of the vaginal discharge under optical microscope
1 secondary outcome
Litmus Paper
Time frame: 2 months
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 2 May 2024.
- Individual participant dataSharing planned: No. All Data including assessment measures, treatment and results
Related trials for Recurrent Vulvovaginal Candidiasis
RecruitingPhase 2
Biweekly Long-term Occidiofungin Study for Suppression of Mycotic Recurrence
Candidiasis, Vulvovaginal
Active, not recruitingPhase 1/2
Assessing the Safety, Immune Response, and Early Efficacy of a Candida Vaccine in Women With Recurrent Vulvovaginal Candidiasis: A Randomized Controlled Study
Recurrent Vulvovaginal Candidiasis
Recruiting
Effect of a Multi-strain Probiotic on Recurrent Vulvovaginal Candidiasis
Vulvovaginal Candidiasis
RecruitingPhase 3
The Effect of Medical Grade Honey Formulation (L-Mesitran) Administration on Recurrent Vulvovaginal Candidiasis Symptoms
Candidiasis, Vulvovaginal, Recurrent Candidiasis of Vagina
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.
Soheir El-kosery, PHD principal investigator
Professor of physical Therapy, Faculty of Physical therapy, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue Light Emitting Diode Therapy and Azole Antifungal in people with Recurrent Vulvovaginal Candidiasis, run by Cairo 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 4 inclusion and 5 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 2 May 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. Some participants in this study may receive a placebo. 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?
Vaginal swab culture . (time frame: 2 months). 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 2 May 2024.