- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05795491
Blue Light Emitting Diode Therapy on Vulvovaginal Candidiasis
Effect of Blue Light Emitting Diode Therapy on Recurrent Vulvovaginal Candidiasis
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt, 11432
- Faculty of physical therapy, Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Group A
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 |
Azole antifungals are a group of medicines that contain an azole ring and inhibit the growth of a wide range of fungi
Other Names:
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Experimental: Group B
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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vaginal swab culture .
Time Frame: 2 months
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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
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2 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Litmus Paper
Time Frame: 2 months
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•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.
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2 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Soheir El-kosery, PHD, Professor of physical Therapy, Faculty of Physical therapy, Cairo University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Bacterial Infections and Mycoses
- Mycoses
- Vaginal Diseases
- Vulvar Diseases
- Vaginitis
- Vulvitis
- Vulvovaginitis
- Candidiasis
- Candidiasis, Vulvovaginal
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Cytochrome P-450 CYP2C9 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Antifungal Agents
- Clotrimazole
- Miconazole
- Fluconazole
Other Study ID Numbers
- 012/004261
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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