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Completed

NCT Number: NCT05770271

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

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.

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Key information

Conditions

Groin Infection Dermatitis Eczema Neurodermatitis Pathological Conditions, Signs and Symptoms Pruritus Psoriasis Signs and Symptoms Skin Diseases Skin Diseases, Eczematous Skin Diseases, Papulosquamous Skin Manifestations Skin and Connective Tissue Diseases

Age range

35 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huinuode Biotechnology Co., Ltd.

Qingdao, China

About this study

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 senile groin eczema, neurodermatitis and psoriasis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The novel electrolyzed water spray

Device

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.

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dove Medical Press Ltd

Network

Registry information

Official study title

A Novel Electrolyzed Water Spray Reduces the Itching Scores of Patients With Mild Senile Groin Eczema, Neurodermatitis and Psoriasis: A Clinical Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 15, 2023
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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