Novel Electrolyzed Water Spray Treatment Mild Dermatophytosis

Sponsor
Dove Medical Press Ltd (Other)
Overall Status
Recruiting
CT.gov ID
NCT05770245
Collaborator
The Affiliated Hospital of Qingdao University (Other)
14
1
1
5
2.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: The novel electrolyzed water spray
N/A

Detailed Description

Recently, water spray containing a mixture of dissolved hydroxyl radicals, H2, O2, O3, and hydrogen peroxide were instantly generated by tap water and a novel electrolyzed water device. In brief, the scientists use the abrasion-resistant, heat-resisting conductive diamond material coating the key part of electrolyzed water device to directly make the tap water into a water spray containing a mixture of dissolved hydroxyl radical, H2, O2, O3, hydrogen peroxide, namely the advanced oxidizing water. Importantly, water spray containing a mixture of dissolved hydroxyl radicals, H2, O2, O3, and hydrogen peroxide does not release gaseous ozone <0.1mg/m3 to the immediate environment that meets the requirement of environmental safety. 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. In brief, 14 patients with mild dermatophytosis, male 6, female 8, average age 45±25 are included. Treatment is to spray the diseased area until about half a bottle (200ml) of water is consumed, 2 times a day, 7 days.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
14 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
An open label, single arm and before and after treatment comparison study
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 29, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. An itching scale made by modifying the Numeric Pain Rating Scale (NPRS) [7 days]

    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

  1. A skin signs scale made by modifying the Numeric Pain Rating Scale (NPRS). [7 days]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Changchun Jiahe Surgery Hospital Jilin Changchun China 130041

Sponsors and Collaborators

  • Dove Medical Press Ltd
  • The Affiliated Hospital of Qingdao University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dove Medical Press Ltd
ClinicalTrials.gov Identifier:
NCT05770245
Other Study ID Numbers:
  • jia19650225
First Posted:
Mar 15, 2023
Last Update Posted:
Mar 22, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dove Medical Press Ltd
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 22, 2023