The Novel Electrolyzed Water Spray Treatment Mild Senile Groin Eczema, Neurodermatitis and Psoriasis
Primary Purpose
Groin Infection, Neurodermatitis, Psoriasis
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
The novel electrolyzed water spray
Sponsored by
About this trial
This is an interventional treatment trial for Groin Infection focused on measuring Electrolyzed water device, Hydroxyl radical, Tap water, Spray, Itching
Eligibility Criteria
Inclusion Criteria: mild senile groin eczema, neurodermatitis and psoriasis. Exclusion Criteria: severe senile groin eczema, neurodermatitis and psoriasis. people with cognitive disorders. 80 years or older.
Sites / Locations
- Huinuode Biotechnology Co., Ltd.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
The mild senile groin eczema, neurodermatitis and psoriasis and one treatment
Arm Description
Participants with itching of mild senile groin eczema, neurodermatitis and psoriasis will receive one treatment with the device and complete the questionnaire.
Outcomes
Primary Outcome Measures
An itching scale made by modifying the Numeric Pain Rating Scale (NPRS)
This Score is based on descriptions of the itching that patients rate 0-10 to assess the condition of their itching. A higher score means a worse outcome. 0 means "no itching " and 10 means "the most itching".
Secondary Outcome Measures
A skin signs scale made by modifying the Numeric Pain Rating Scale (NPRS).
The signs of skin chronic inflammation include darkness or redness, swelling and dryness and broken surface and reduced area of the diseased skin. This Score is based on descriptions of signs of senile groin eczema, neurodermatitis and psoriasis rated 0-10 to assess the condition of mild inflammation of the skin and groin. A higher score means a worse outcome.
Full Information
NCT ID
NCT05770271
First Posted
February 26, 2023
Last Updated
August 13, 2023
Sponsor
Dove Medical Press Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05770271
Brief Title
The Novel Electrolyzed Water Spray Treatment Mild Senile Groin Eczema, Neurodermatitis and Psoriasis
Official Title
A Novel Electrolyzed Water Spray Reduces the Itching Scores of Patients With Mild Senile Groin Eczema, Neurodermatitis and Psoriasis: 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 20, 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 itching of inflammation skin and groin patients by use of the novel electrolyzed water spray will produce improvement in the condition of 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 mild senile groin eczema, neurodermatitis and psoriasis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Groin Infection, Neurodermatitis, Psoriasis, Eczema
Keywords
Electrolyzed water device, Hydroxyl radical, Tap water, Spray, Itching
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
An open label, single arm and before and after treatment comparison study
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The mild senile groin eczema, neurodermatitis and psoriasis and one treatment
Arm Type
Experimental
Arm Description
Participants with itching of mild senile groin eczema, neurodermatitis and psoriasis 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 5 minutes on the participant's diseased area until half a bottle (200ml) of water is used. The patients use electrolyzed water to treat the diseased area, two times a day, for 10 days. The trial consists of 10 study visits (day 1-day 10). The relief of mild senile groin eczema, neurodermatitis and psoriasis 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 the Numeric Pain Rating Scale (NPRS)
Description
This Score is based on descriptions of the itching that patients rate 0-10 to assess the condition of their itching. A higher score means a worse outcome. 0 means "no itching " and 10 means "the most itching".
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
A skin signs scale made by modifying the Numeric Pain Rating Scale (NPRS).
Description
The signs of skin chronic inflammation include darkness or redness, swelling and dryness and broken surface and reduced area of the diseased skin. This Score is based on descriptions of signs of senile groin eczema, neurodermatitis and psoriasis rated 0-10 to assess the condition of mild inflammation of the skin and groin. A higher score means a worse outcome.
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
mild senile groin eczema, neurodermatitis and psoriasis.
Exclusion Criteria:
severe senile groin eczema, neurodermatitis and psoriasis.
people with cognitive disorders.
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 Mild Senile Groin Eczema, Neurodermatitis and Psoriasis
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