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The Novel Electrolyzed Water Spray Treatment the Genital Itching

Primary Purpose

Genital Inflammation, Itching

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
The novel electrolyzed water spray
Sponsored by
Dove Medical Press Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genital Inflammation focused on measuring Electrolyzed water device, Hydroxyl radical, Tap water, Spray, Genital itching

Eligibility Criteria

40 Years - 62 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with genital itching. Exclusion Criteria: Severe genital itching. 80 years or older.

Sites / Locations

  • Huinuode Biotechnology Co., Ltd.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The genital itching and one treatment

Arm Description

Participants with itching genitalia will receive one treatment with the device and complete the questionnaire.

Outcomes

Primary Outcome Measures

An itching scale made by modifying a pain scale (NPRS)
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".

Secondary Outcome Measures

Full Information

First Posted
February 27, 2023
Last Updated
August 13, 2023
Sponsor
Dove Medical Press Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05766930
Brief Title
The Novel Electrolyzed Water Spray Treatment the Genital Itching
Official Title
A Novel Electrolyzed Water Spray Reduces the Itching Scores of Patients With Genital Itching: A Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 29, 2023 (Actual)
Primary Completion Date
July 15, 2023 (Actual)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dove Medical Press Ltd

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Inflammation, Itching
Keywords
Electrolyzed water device, Hydroxyl radical, Tap water, Spray, Genital itching

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
An open label, single arm and before and after treatment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The genital itching and one treatment
Arm Type
Experimental
Arm Description
Participants with itching genitalia will receive one treatment with the device and complete the questionnaire.
Intervention Type
Device
Intervention Name(s)
The novel electrolyzed water spray
Intervention Description
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.
Primary Outcome Measure Information:
Title
An itching scale made by modifying a pain scale (NPRS)
Description
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".
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
62 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with genital itching. Exclusion Criteria: Severe genital itching. 80 years or older.
Facility Information:
Facility Name
Huinuode Biotechnology Co., Ltd.
City
QingDao
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
until publication of this clinical study and international patent granted

Learn more about this trial

The Novel Electrolyzed Water Spray Treatment the Genital Itching

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