search
Back to results

Blue Light Emitting Diode Therapy on Vulvovaginal Candidiasis

Primary Purpose

Recurrent Vulvovaginal Candidiasis

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Blue Light Emitting Diode Therapy
Azole Antifungal
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Vulvovaginal Candidiasis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of physical therapy, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Group A

Group B

Arm 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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
March 21, 2023
Last Updated
April 1, 2023
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT05795491
Brief Title
Blue Light Emitting Diode Therapy on Vulvovaginal Candidiasis
Official Title
Effect of Blue Light Emitting Diode Therapy on Recurrent Vulvovaginal Candidiasis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Vulvovaginal Candidiasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Placebo Comparator
Arm 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
Arm Title
Group B
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Blue Light Emitting Diode Therapy
Other Intervention Name(s)
Blue LED
Intervention Description
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
Drug
Intervention Name(s)
Azole Antifungal
Other Intervention Name(s)
fluconazole
Intervention Description
Azole antifungals are a group of medicines that contain an azole ring and inhibit the growth of a wide range of fungi
Primary Outcome Measure Information:
Title
Vaginal swab culture .
Description
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
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Litmus Paper
Description
•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.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soheir El-kosery, PHD
Organizational Affiliation
Professor of physical Therapy, Faculty of Physical therapy, Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of physical therapy, Cairo University
City
Cairo
ZIP/Postal Code
11432
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All Data including assessment measures, treatment and results

Learn more about this trial

Blue Light Emitting Diode Therapy on Vulvovaginal Candidiasis

We'll reach out to this number within 24 hrs