Blue Light Emitting Diode Therapy on Vulvovaginal Candidiasis

Cairo University (CU)

Status: Completed

Conditions: Recurrent Vulvovaginal Candidiasis

Treatments: Drug: Azole Antifungal; Device: Blue Light Emitting Diode Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05795491

012/004261

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Group A

Placebo Comparator group

Description:

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

Treatment:

Drug: Azole Antifungal

Group B

Experimental group

Description:

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.

Treatment:

Device: Blue Light Emitting Diode Therapy