Blue Light Emitting Diode Therapy on Vulvovaginal Candidiasis

NCT ID: NCT05795491

Last Updated: 2024-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2023-06-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: PLACEBO_COMPARATOR

Azole Antifungal

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Blue Light Emitting Diode Therapy

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Azole Antifungal

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

Intervention Type: DRUG

Other Intervention Names

Blue LED; fluconazole

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Radwa Mohamed Reda Shalaby

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Soheir El-kosery, PHD

Role: PRINCIPAL_INVESTIGATOR

Professor of physical Therapy, Faculty of Physical therapy, Cairo University

Locations

Faculty of physical therapy, Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

012/004261

Identifier Type: -

Identifier Source: org_study_id