The Novel Electrolyzed Water Spray Treatment the Genital Itching

Not Applicable

Completed

• Conditions: Itching; Genital Inflammation
• Interventions: Device: The novel electrolyzed water spray

• Registration Number: NCT05766930
• Lead Sponsor: Dove Medical Press Ltd

Brief 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.

Study Timeline

• Study Start: 2023-01-29
• Status Verified: 2023-02
• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-03-02
• Study First Posted: 2023-03-13
• Primary Completion: 2023-07-15
• Study Completion: 2024-03-01
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Patients with genital itching.

Exclusion Criteria

Severe genital itching. 80 years or older.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The genital itching and one treatment	The novel electrolyzed water spray	Participants with itching genitalia will receive one treatment with the device and complete the questionnaire.

Primary Outcome Measures

Name	Time	Method
An itching scale made by modifying a pain scale (NPRS)	5 days	This Score is based on descriptions of the itching that patients rate 0-10 to assess the condition of their genitalia with itching. A higher score means a worse outcome. 0 means "no itching " and 10 means "the most itching".

Trial Locations

Locations (1)

Huinuode Biotechnology Co., Ltd.; 🇨🇳 QingDao, China