Skip to main content
OpenTrials
Completed

NCT Number: NCT05795491

Blue Light Emitting Diode Therapy on Vulvovaginal Candidiasis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Recurrent Vulvovaginal Candidiasis Bacterial Infections and Mycoses Candidiasis Candidiasis, Vulvovaginal Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Mycoses Urogenital Diseases Vaginal Diseases Vaginitis Vulvar Diseases Vulvitis Vulvovaginitis

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of physical therapy, Cairo University

Cairo, 11432, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blue Light Emitting Diode Therapy

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.

Other names: Blue LED

Azole Antifungal

Drug

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

Other names: fluconazole

Primary outcomes

  1. Vaginal swab culture .

    Time frame: 2 months

    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

Secondary outcomes

  1. Litmus Paper

    Time frame: 2 months

    •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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Blue Light Emitting Diode Therapy on Recurrent Vulvovaginal Candidiasis

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 3, 2023
Registry last updated
May 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.