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

Study Overview
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Brief Summary
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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.

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

Conditions
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Eczema

Intervention / Treatment
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* Drug: Atoderm SOS spray Aerosol 200ml


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Treatment Group<br>Patients will be instructed to use the anti-pruritic spray for four weeks starting from the day which informed consent was signed in active treatment group. A follow-up visit will be on week 2 for a mid-term review. | Drug: Atoderm SOS spray Aerosol 200ml<br>* A bottle of 200ml topical spray was used on the eczematous skin lesions for itch relief.<br>|
| Active Comparator: Wait-list Control Group<br>Patients will be instructed to start the treatment after two weeks from the day which consent was signed and for a duration of two weeks in wait-list control group. A follow-up visit will be on week 2 for a mid-term review and for the dispense of treating material. | Drug: Atoderm SOS spray Aerosol 200ml<br>* A bottle of 200ml topical spray was used on the eczematous skin lesions for itch relief.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SCORing Atopic Dermatitis (SCORAD) | A questionnaire to examine the difference in eczema severity between two arms | 4 weeks | 
| The Patient Oriented Eczema Measure (POEM) | A questionnaire to examine the difference in eczema severity between two arms | 4 weeks | 
| Nottingham Eczema Severity Score (NESS) | A questionnaire to examine the difference in eczema severity between two arms | 4 weeks | 
| The Children's Dermatology Life Quality Index (CDLQI) | A questionnaire to examine the difference in quality of life between two arms | 4 weeks | 
| Pediatric Allergic Disease Quality of Life Questionnaire (PADQLQ) | A questionnaire to examine the difference in quality of life between two arms | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial colonization | Investigating the presence of Staphylococcus aureus | 4 weeks | 
| dermatological parameters on skin | Measuring the level of skin hydration, transepidermal water loss, and erythema | 4 weeks | 
| seromarkers | Measuring the amount of Brain-derived neurotrophic factor, anti-Staphylococcal enterotoxin B antibody, Immunoglobulin E, and complete blood counts. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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itch relief, childhood, eczema, topical spray, quality of life