Skip to main content
OpenTrials
Completed

NCT Number: NCT04986384

Effect of a Topical Spray on Itch Relief in Moderate-to-severe Childhood Eczema

Pruritus is defined as an unpleasant sensation of the skin that provoke the desire to scratch or rub. Its presence is an essential diagnostic feature. According to some European studies, 91% of patients with Atopic Dermatitis report suffering from pruritus at least once daily. And 58.1% of them experience chronic pruritus, leading to great deterioration in quality of life. Various internal and external factors may trigger pruritus. Mediators secretion such as keratinocyte-derived Thymic Stromal Lymphopoietin (TSLP) and Nerve Growth Factor (NGF) could activate nerve fibres which will eventually transmit signals to the brain causing the sensation of itching.

Although being one of the major annoying symptoms faced by patients with Atopic Dermatitis, effective anti-itching treatments are not available. There is no consistent evidence that topical antihistamines can relief itch.

Recently, a new spray named Atoderm 'SOS' is developed. The skin relief technology (by ambora extract and Epigallocatechin gallate (EGCG), associated to enoxolone) claimed to inhibit the release TSLP and NGF which eventually could reduce nerve signals to the brain for itchy feelings. Therefore, our group would like to test the efficacy of this proprietary anti-itch product with our paediatric patients using a wait-list approach as a control. It is aimed to demonstrate that the using the Atoderm 'SOS' spray topically whenever necessary can reduce the unpleasant itchy Atopic Dermatitis's symptom, improve quality of life, as well as to reduce the need for topical treatment.

Completed

Looking for future studies?

Notify Me

Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Paediatrics, The Chinese University of Hong Kong

Hong Kong, 00000

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A pruritus frequency of more than 3 days in previous week recorded by Q1 in The Patient Oriented Eczema Measure (POEM)
  • History of known moderate-to-severe eczema
  • Able to read Chinese
  • voluntarily willing to participate into the study by written consents endorsed by patients and their legal guardians

Exclusion criteria

  • No history of known eczema
  • Concurrently participating into another clinical trial
  • History of known drug allergy
  • unable to read Chinese

Treatment and study plan

Atoderm SOS spray Aerosol 200ml

Drug

A bottle of 200ml topical spray was used on the eczematous skin lesions for itch relief.

Primary outcomes

  1. SCORing Atopic Dermatitis (SCORAD)

    Time frame: 4 weeks

    A questionnaire to examine the difference in eczema severity between two arms

  2. The Patient Oriented Eczema Measure (POEM)

    Time frame: 4 weeks

    A questionnaire to examine the difference in eczema severity between two arms

  3. Nottingham Eczema Severity Score (NESS)

    Time frame: 4 weeks

    A questionnaire to examine the difference in eczema severity between two arms

  4. The Children's Dermatology Life Quality Index (CDLQI)

    Time frame: 4 weeks

    A questionnaire to examine the difference in quality of life between two arms

  5. Pediatric Allergic Disease Quality of Life Questionnaire (PADQLQ)

    Time frame: 4 weeks

    A questionnaire to examine the difference in quality of life between two arms

Secondary outcomes

  1. Bacterial colonization

    Time frame: 4 weeks

    Investigating the presence of Staphylococcus aureus

  2. dermatological parameters on skin

    Time frame: 4 weeks

    Measuring the level of skin hydration, transepidermal water loss, and erythema

  3. seromarkers

    Time frame: 4 weeks

    Measuring the amount of Brain-derived neurotrophic factor, anti-Staphylococcal enterotoxin B antibody, Immunoglobulin E, and complete blood counts.

Sponsors and collaborators

Lead sponsor

Prof. HON Kam Lun Ellis

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 2, 2021
Registry last updated
Aug 2, 2021

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.

Published trials that share one or more normalized conditions with this study.