NCT05795491

Blue Light Emitting Diode Therapy on Vulvovaginal Candidiasis

Effect of Blue Light Emitting Diode Therapy on Recurrent Vulvovaginal Candidiasis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-04-01
• Primary completion: 2023-05-01
• Completion: 2023-06-01
• First posted: 2023-04-03
• Last updated: 2024-05-02

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated device study