Back to resultsA Novel Electrolyzed Water Spray Treatment for the Discomfort or Itching of Patients With Scalp
Primary Purpose
Scalp Dermatoses
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
A novel electrolyzed water spray
Sponsored by
About this trial
This is an interventional treatment trial for Scalp Dermatoses focused on measuring Electrolyzed water device, Hydroxyl radical, Tap water, Spray, Scalp discomfort, Scalp itching
Eligibility Criteria
Inclusion Criteria: The patients with scalp discomfort or itching Exclusion Criteria: severe scalp discomfort or itching; 80 years or elder
Sites / Locations
- Huinuode Biotechnology Co., Ltd.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
The scalp of discomfort or itching and one treatment
Arm Description
Participants with discomfort or itching scalp who will receive one treatment with the device and complete the questionnaire.
Outcomes
Primary Outcome Measures
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".
Secondary Outcome Measures
Full Information
NCT ID
NCT05765526
First Posted
February 27, 2023
Last Updated
August 13, 2023
Sponsor
Dove Medical Press Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05765526
Brief Title
A Novel Electrolyzed Water Spray Treatment for the Discomfort or Itching of Patients With Scalp
Official Title
A Novel Electrolyzed Water Spray Reduces Discomfort or Itching Scores of Patients With Scalp Discomfort or 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 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scalp Dermatoses
Keywords
Electrolyzed water device, Hydroxyl radical, Tap water, Spray, Scalp discomfort, Scalp 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
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The scalp of discomfort or itching and one treatment
Arm Type
Experimental
Arm Description
Participants with discomfort or itching scalp who will receive one treatment with the device and complete the questionnaire.
Intervention Type
Device
Intervention Name(s)
A novel electrolyzed water spray
Intervention Description
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.
Primary Outcome Measure Information:
Title
A discomfort or itching scale made by modifing a pain scale (NPRS)
Description
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".
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patients with scalp discomfort or itching
Exclusion Criteria:
severe scalp discomfort or itching; 80 years or elder
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
A Novel Electrolyzed Water Spray Treatment for the Discomfort or Itching of Patients With Scalp
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