NCT05766930

The Novel Electrolyzed Water Spray Treatment the Genital Itching

A Novel Electrolyzed Water Spray Reduces the Itching Scores of Patients With Genital Itching: A Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Dove Medical Press Ltd · Network
• Sex: All
• Age: 40 Years – 62 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test whether spraying the genitalia of patients by use of the novel electrolyzed water spray will produce improvement in the condition of genitalia itching.

Detailed description

In this study, water inculding tap water,pure water and salt water, and an apparatus for producing electrolyzed water (https://www.deposon.com.cn; https://www.deposon.com）were used to generate an electrolyzed water mist spray or spray. This instantly generated electrolyzed water mist spray or spray has oxidation-reduction potential (ORP) ≥1200mv,and contains non-specific total oxidation capacity which equals to 0.28±0.10ppm,0.06±0.04ppm and 3.92±0.39ppm of desolved ozone. This instantly generated electrolyzed water mist spray or spray does not release detectable ≥0.1mg/m3 of gaseous ozone. This instantly generated electrolyzed water mist spray or spray has pH 8.4±0.4 and releases negative air ion.The apparatus for producing electrolyzed water has a positive electrode which is covered by a conductive diamond material (Patent# CN215308550U). This is an open-label, single-arm, and before and after treatment comparison study. This study uses this novel electrolyzed water device and the water spray to treat genital itching.

Conditions

• Genital Inflammation
• Itching

Interventions

Type	Name	Description
DEVICE	The novel electrolyzed water spray	Study staff will use the novel electrolyzed water spray device and spray for approximately 2-4 minutes on the participant's diseased area until half a bottle (20-40ml) of water is used. The patients use electrolyzed water to treat the diseased area, two times a day, for 5 days. The trial consists of 5 study visits (day 1-day 5). The relief genital itching evaluation and adverse event assessments will be performed at each visit. Safety analysis will be assessed based on the reports of adverse events during the study.

Timeline

• Start date: 2023-01-29
• Primary completion: 2023-07-15
• Completion: 2024-03-01
• First posted: 2023-03-13
• Last updated: 2024-04-25

Locations

1 site across 1 country: China