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.

Study Overview

• Status: Completed
• Conditions: Eczema
• Intervention / Treatment: Drug: Atoderm SOS spray Aerosol 200ml

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 00000
    • Department of Paediatrics, The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Treatment Group; 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; A bottle of 200ml topical spray was used on the eczematous skin lesions for itch relief.
Active Comparator: Wait-list Control Group; 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; A bottle of 200ml topical spray was used on the eczematous skin lesions for itch relief.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Prof. HON Kam Lun Ellis
• Investigators: Principal Investigator: Kam Lun Ellis KL Hon, MD, MBBS, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2019
• Primary Completion (Actual): April 7, 2021
• Study Completion (Actual): April 7, 2021

Study Registration Dates

• First Submitted: May 29, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): August 2, 2021

Study Record Updates

• Last Update Posted (Actual): August 2, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: quality of life; eczema; childhood; itch relief; topical spray
• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Eczema
• Other Study ID Numbers: BAIS2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The IPD involved sensitive clinical information which was regarded as patients' privacy. The overall study results could be found in published journal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No