Blue Light Emitting Diode Therapy on Vulvovaginal Candidiasis

Recurrent Vulvovaginal Candidiasis Clinical Trial

Official title:

Effect of Blue Light Emitting Diode Therapy on Recurrent Vulvovaginal Candidiasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05795491
• Other study ID #: 012/004261
• Status: Completed
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: June 1, 2023

Study information

• Verified date: May 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 clinical manifestation of candidiasis and its ability to prevent recurrence.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

subject selection will be according to the following criteria:

1. Age will range between 18- 50 years.

2. All patients will be confirmed by culture and examination of fresh vaginal samples, to have VVC.

3. 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:

1. Individuals on any other antifungal drugs.

2. Individuals with cardiopulmonary conditions.

3. Individuals undergoing another radiation therapy.

4. Sensory impairment

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Recurrent Vulvovaginal Candidiasis

Intervention

Device:
• Blue Light Emitting Diode Therapy
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.

Drug:
• Azole Antifungal
Azole antifungals are a group of medicines that contain an azole ring and inhibit the growth of a wide range of fungi

Locations

Country	Name	City	State
Egypt	Faculty of physical therapy, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 months
Secondary	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.	2 months