NCT05770271

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2023

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2024

Completed
Last Updated

April 25, 2024

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

February 26, 2023

Last Update Submit

April 24, 2024

Conditions

Keywords

Electrolyzed water deviceHydroxyl radicalTap waterSprayItching

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

    1 hour

Secondary Outcomes (1)

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

    10 days

Study Arms (1)

The mild senile groin eczema, neurodermatitis and psoriasis and one treatment

EXPERIMENTAL

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

Interventions

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.

The mild senile groin eczema, neurodermatitis and psoriasis and one treatment

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • mild senile groin eczema, neurodermatitis and psoriasis.

You may not qualify if:

  • severe senile groin eczema, neurodermatitis and psoriasis.
  • people with cognitive disorders.
  • years or older.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huinuode Biotechnology Co., Ltd.

Qingdao, China

Location

MeSH Terms

Conditions

NeurodermatitisPsoriasisEczemaPruritus

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousSkin Diseases, PapulosquamousSkin ManifestationsSigns and SymptomsPathological 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 26, 2023

First Posted

March 15, 2023

Study Start

January 29, 2023

Primary Completion

July 20, 2023

Study Completion

January 20, 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