The Novel Electrolyzed Water Spray Treatment Mild Senile Groin Eczema, Neurodermatitis and Psoriasis

Sponsor
Dove Medical Press Ltd (Other)
Overall Status
Recruiting
CT.gov ID
NCT05770271
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 itching of inflammation skin and groin patients by use of the novel electrolyzed water spray will produce improvement in the condition of itching.

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 senile groin eczema, neurodermatitis and psoriasis. Briefly, 14 patients with mild senile groin eczema (n=7), neurodermatitis (n=3) and psoriasis (n=4), male 6, female 8, average age 50±15 are included. Treatment is to spray the diseased area until half a bottle (200ml) of water is used, 2 times a day, 10 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 Itching Scores of Patients With Mild Senile Groin Eczema, Neurodermatitis and Psoriasis: 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: The mild senile groin eczema, neurodermatitis and psoriasis and one treatment

Participants with itching of mild senile groin eczema, neurodermatitis and psoriasis will receive one treatment with the device and complete the questionnaire.

Device: The novel electrolyzed water spray
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.

Outcome Measures

Primary Outcome Measures

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

    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

  1. A skin signs scale made by modifying the Numeric Pain Rating Scale (NPRS). [10 days]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Changchun Jiahe Surgery Hospital Changchun Jilin 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:
NCT05770271
Other Study ID Numbers:
  • jia19960129
First Posted:
Mar 15, 2023
Last Update Posted:
Mar 21, 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 21, 2023