The Novel Electrolyzed Water Spray Treatment the Genital Itching

NCT05766930 | Completed DMC

• 1 other identifier: jia19951210
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Genital Inflammation; Itching

Keywords

Electrolyzed water device; Hydroxyl radical; Tap water; Spray; Genital itching

Outcome Measures

Primary Outcomes (1)

• 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".

  5 days

Study Arms (1)

The genital itching and one treatment

EXPERIMENTAL

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

Device: The novel electrolyzed water spray

Interventions

The novel electrolyzed water spray DEVICE

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.

The genital itching and one treatment

Eligibility Criteria

• Age: 40 Years - 62 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with genital itching.

You may not qualify if:

• Severe genital itching. 80 years or older.

Sponsors & Collaborators

• Dove Medical Press Ltd: lead

Study Sites (1)

Huinuode Biotechnology Co., Ltd.

Qingdao, China

Location

MeSH Terms

Conditions

Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: An open label, single arm and before and after treatment

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 13, 2023
• Study Start: January 29, 2023
• Primary Completion: July 15, 2023
• Study Completion: March 1, 2024
• Last Updated: April 25, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: until publication of this clinical study and international patent granted

Locations

CN (1)