The Novel Electrolyzed Water Spray Treatment Mild Senile Groin Eczema, Neurodermatitis and Psoriasis
A Novel Electrolyzed Water Spray Reduces the Itching Scores of Patients With Mild Senile Groin Eczema, Neurodermatitis and Psoriasis: A Clinical Study
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 29, 2023
CompletedFirst Submitted
Initial submission to the registry
February 26, 2023
CompletedFirst Posted
Study publicly available on registry
March 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2024
CompletedApril 25, 2024
February 1, 2023
6 months
February 26, 2023
April 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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".
1 hour
Secondary Outcomes (1)
A skin signs scale made by modifying the Numeric Pain Rating Scale (NPRS).
10 days
Study Arms (1)
The mild senile groin eczema, neurodermatitis and psoriasis and one treatment
EXPERIMENTALParticipants with itching of mild senile groin eczema, neurodermatitis and psoriasis will receive one treatment with the device and complete the questionnaire.
Interventions
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.
Eligibility Criteria
You may qualify if:
- mild senile groin eczema, neurodermatitis and psoriasis.
You may not qualify if:
- severe senile groin eczema, neurodermatitis and psoriasis.
- people with cognitive disorders.
- years or older.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Huinuode Biotechnology Co., Ltd.
Qingdao, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- An open label, single arm and before and after treatment comparison study
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2023
First Posted
March 15, 2023
Study Start
January 29, 2023
Primary Completion
July 20, 2023
Study Completion
January 20, 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