Blue Light Emitting Diode Therapy on Vulvovaginal Candidiasis

• Sponsor: Cairo University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05795491
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 2
• Patients Per Site Per Month: 29.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Vulvovaginal Candidiasis	Device: Blue Light Emitting Diode Therapy; Drug: Azole Antifungal	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Effect of Blue Light Emitting Diode Therapy on Recurrent Vulvovaginal Candidiasis
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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	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; Other Names: fluconazole
Experimental: 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.	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.; Other Names: Blue LED

Outcome Measures

Primary Outcome Measures

1. Vaginal swab culture . [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 Outcome Measures

1. Litmus Paper [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of physical therapy, Cairo University	Cairo		Egypt	11432

Sponsors and Collaborators

• Cairo University

Investigators

• Principal Investigator: Soheir El-kosery, PHD, Professor of physical Therapy, Faculty of Physical therapy, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Radwa Mohamed Reda Shalaby, Physiotherapist, Cairo University
• ClinicalTrials.gov Identifier: NCT05795491
• Other Study ID Numbers: 012/004261
• First Posted: Apr 3, 2023
• Last Update Posted: Apr 5, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Candidiasis; Candidiasis, Vulvovaginal; Fluconazole; Antifungal Agents; Clotrimazole; Miconazole

Study Results

No Results Posted as of Apr 5, 2023