A Novel Electrolyzed Water Spray Treatment for the Discomfort or Itching of Patients With Scalp

Study Overview
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Brief Summary
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The purpose of this study is to test whether the reduction of the discomfort or itching with the scalp of patients by use of the novel electrolyzed water spray will produce improvement in the condition of the scalp.

Detailed Description
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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. In this study, this novel electrolyzed water device and the water spray are used to treat scalp itching. The reduction in the scalp of discomfort or 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.

Official Title
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A Novel Electrolyzed Water Spray Reduces Discomfort or Itching Scores of Patients With Scalp Discomfort or Itching: A Clinical Study

Conditions
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Scalp Dermatoses

Intervention / Treatment
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* Device: A novel electrolyzed water spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients with scalp discomfort or itching Exclusion Criteria: severe scalp discomfort or itching; 80 years or elder

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: An open label, single arm and before and after treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The scalp of discomfort or itching and one treatment<br>Participants with discomfort or itching scalp who will receive one treatment with the device and complete the questionnaire. | Device: A novel electrolyzed water spray<br>* Study staff will use the novel electrolyzed water spray device and spray for approximately 10 minutes on the participant's scalp until half bottle (200ml) of water is used. Their scalp will then be rinsed and gently dried with a towel.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A discomfort or itching scale made by modifing a pain scale (NPRS) | This Score is based on descriptions of the discomfort or itching that patients rate 0-10 to assess the condition of their scalp. A higher score means a worse outcome. 0 means no discomfort or itching  and 10 means the most discomfort or itching. | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrolyzed water device, Hydroxyl radical, Tap water, Spray, Scalp discomfort, Scalp itching