Novel Electrolyzed Water Spray Treatment Mild Dermatophytosis
Primary Purpose
Dermatophytoses
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 Dermatophytoses focused on measuring Electrolyzed water device, Hydroxyl radical, Tap water, Spray, Dermatophytosis, Itching
Eligibility Criteria
Inclusion Criteria: mild dermatophytosis accompanied by significant itching symptom Patient > 18 years old. Exclusion Criteria: severe dermatophytosis. 80 years or older. Pregnant or breastfeeding women.
Sites / Locations
- Huinuode Biotechnology Co., Ltd.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mild dermatophytosis and one treatment
Arm Description
Study staff will use the novel electrolyzed water spray device and spray for approximately 10 minutes on the participant's diseased area until half a bottle (200ml) of water is used.
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 mild dermatophytosis. 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 skin signs scale evaluates the disease-damaged skin replaced by fresh and healthy skin. This Score is based on descriptions of darkness or redness, swelling and dryness, broken surface, and reduced diseased skin area patients rate 0-10. A higher score means a worse outcome.
Full Information
NCT ID
NCT05770245
First Posted
February 27, 2023
Last Updated
August 13, 2023
Sponsor
Dove Medical Press Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05770245
Brief Title
Novel Electrolyzed Water Spray Treatment Mild Dermatophytosis
Official Title
A Novel Electrolyzed Water Spray Reduces the Discomfort or Itching Scores, and Promotes Healing of the Damaged Skin of Patients With Mild Dermatophytosis: 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 skin of patients of patients by use of the novel electrolyzed water spray will produce improvement in the condition of mild dermatophytosis.
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 dermatophytosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatophytoses
Keywords
Electrolyzed water device, Hydroxyl radical, Tap water, Spray, Dermatophytosis, 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
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mild dermatophytosis and one treatment
Arm Type
Experimental
Arm Description
Study staff will use the novel electrolyzed water spray device and spray for approximately 10 minutes on the participant's diseased area until half a bottle (200ml) of water is used.
Intervention Type
Device
Intervention Name(s)
The novel electrolyzed water spray
Intervention Description
The researcher used electrolyzed water or piped water to treat the diseased area two times a day for five days. The trial consists of 7 study visits (day 1-day 7). The reduction in the disease area of discomfort or itching scores and promoting healing of the damaged skin of patients with mild dermatophytosis 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 mild dermatophytosis. A higher score means a worse outcome. 0 means "no itching " and 10 means "the most itching".
Time Frame
7 days
Secondary Outcome Measure Information:
Title
A skin signs scale made by modifying the Numeric Pain Rating Scale (NPRS).
Description
The skin signs scale evaluates the disease-damaged skin replaced by fresh and healthy skin. This Score is based on descriptions of darkness or redness, swelling and dryness, broken surface, and reduced diseased skin area patients rate 0-10. A higher score means a worse outcome.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
mild dermatophytosis accompanied by significant itching symptom
Patient > 18 years old.
Exclusion Criteria:
severe dermatophytosis.
80 years or older.
Pregnant or breastfeeding women.
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
Novel Electrolyzed Water Spray Treatment Mild Dermatophytosis
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