Novel Electrolyzed Water Spray Treatment Mild Dermatophytosis

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

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.

Study Overview

• Status: Completed
• Conditions: Dermatophytoses
• Intervention / Treatment: Device: The novel electrolyzed water spray

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaoxiao Jia; Phone Number: 15621486915; Email: 15621486915@163.com
• Study Contact Backup: Name: Mizhou Hui; Phone Number: 134 8400 5199; Email: mizhou.hui@alumni.utoronto.ca

Study Locations

• China
  • Qingdao, China
    • Huinuode Biotechnology Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Mild dermatophytosis and one treatment; 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.

Device: The novel electrolyzed water spray; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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".	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 days

Collaborators and Investigators

• Sponsor: Dove Medical Press Ltd
• Collaborators: The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2023
• Primary Completion (Actual): July 20, 2023
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: March 5, 2023
• First Posted (Actual): March 15, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Itching; Spray; Dermatophytosis; Electrolyzed water device; Hydroxyl radical; Tap water
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Tinea; Dermatomycoses
• Other Study ID Numbers: jia19650225

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: until publication of this clinical study and international patent granted
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No