The Novel Electrolyzed Water Spray Treatment the Genital Itching

Sponsor

Dove Medical Press Ltd (Other)

Overall Status

Recruiting

CT.gov ID

NCT05766930

Collaborator

The Affiliated Hospital of Qingdao University (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Genital Inflammation Itching	Device: The novel electrolyzed water spray	N/A

Detailed Description

Recently, water spray containing a mixture of dissolved hydroxyl radicals, H2, O2, O3, and hydrogen peroxide was instantly generated by tap water and a novel electrolyzed water device (https://www.deposon.com.cn; https://www.deposon.com). In brief, the scientists use the abrasion-resistant, heat-resisting conductive diamond material coating the key part of electrolyzed water device to directly make the tap water into a water spray containing a mixture of dissolved hydroxyl radical, H2, O2, O3, hydrogen peroxide, namely the advanced oxidizing water. Importantly, water spray containing a mixture of dissolved hydroxyl radicals, H2, O2, O3, and hydrogen peroxide does not release gaseous ozone <0.1mg/m3 to the immediate environment that meets the requirement of environmental safety.

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. In brief, 14 patients with genital itching, male 7, female 7, average age 52±12 are included. Treatment is to spray the diseased area until half a bottle (200ml) of water is used, 2 times a day, 5 days. The primary outcome measure uses an itching scale made by modifying a pain scale (NPRS) for 5 days.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

An open label, single arm and before and after treatmentAn open label, single arm and before and after treatment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 29, 2023

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: The genital itching and one treatment Participants with itching genitalia will receive one treatment with the device and complete the questionnaire.	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.

Arm

Intervention/Treatment

Experimental: The genital itching and one treatment

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

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.

Outcome Measures

Primary Outcome Measures

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".

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 62 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with genital itching.

Exclusion Criteria:

Severe genital itching. 80 years or older.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Changchun Jiahe Surgery Hospital	Jilin	Changchun	China	130041

Sponsors and Collaborators

Dove Medical Press Ltd
The Affiliated Hospital of Qingdao University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dove Medical Press Ltd

ClinicalTrials.gov Identifier:

NCT05766930

Other Study ID Numbers:

jia19951210

First Posted:

Mar 13, 2023

Last Update Posted:

Mar 13, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dove Medical Press Ltd

Electrolyzed water device

Additional relevant MeSH terms:

Pruritus

Inflammation

Study Results

No Results Posted as of Mar 13, 2023