Blue Light Emitting Diode Therapy on Vulvovaginal Candidiasis

NCT05795491 | Completed FDA Device

• 1 other identifier: 012/004261
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Vulvovaginal Candidiasis

Outcome Measures

Primary Outcomes (1)

• 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

  2 months

Secondary Outcomes (1)

• Litmus Paper

  2 months

Study Arms (2)

Group A

PLACEBO COMPARATOR

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

Group B

EXPERIMENTAL

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

Interventions

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.

Also known as: Blue LED

Group B

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

Also known as: fluconazole

Group A

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy, Cairo University

Cairo, 11432, Egypt

Location

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Interventions

Fluconazole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Soheir El-kosery, PHD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 3, 2023
• Study Start: April 1, 2023
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: May 2, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)