Novel Electrolyzed Water Spray Treatment Mild Dermatophytosis

NCT05770245 | Completed DMC

• 1 other identifier: jia19650225
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatophytoses

Keywords

Electrolyzed water device; Hydroxyl radical; Tap water; Spray; Dermatophytosis; Itching

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 mild dermatophytosis. A higher score means a worse outcome. 0 means "no itching " and 10 means "the most itching".

  7 days

Secondary Outcomes (1)

• A skin signs scale made by modifying the Numeric Pain Rating Scale (NPRS).

  7 days

Study Arms (1)

Mild dermatophytosis and one treatment

EXPERIMENTAL

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

Interventions

The novel electrolyzed water spray DEVICE

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.

Mild dermatophytosis and one treatment

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mild dermatophytosis accompanied by significant itching symptom
• Patient \> 18 years old.

You may not qualify if:

• severe dermatophytosis.
• years or older.
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• Dove Medical Press Ltd: lead

Study Sites (1)

Huinuode Biotechnology Co., Ltd.

Qingdao, China

Location

MeSH Terms

Conditions

Tinea; Pruritus

Condition Hierarchy (Ancestors)

Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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 27, 2023
• First Posted: March 15, 2023
• Study Start: January 29, 2023
• Primary Completion: July 20, 2023
• Study Completion: February 1, 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

Locations

CN (1)