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

Eczema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04986384
• Other study ID #: BAIS2018
• Status: Completed
• Phase: N/A
• Start date: January 24, 2019
• Est. completion date: April 7, 2021

Study information

• Verified date: May 2021
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 7, 2021
• Est. primary completion date: April 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Eczema

Intervention

Drug:
• Atoderm SOS spray Aerosol 200ml
A bottle of 200ml topical spray was used on the eczematous skin lesions for itch relief.

Locations

Country	Name	City	State
Hong Kong	Department of Paediatrics, The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Prof. HON Kam Lun Ellis

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SCORing Atopic Dermatitis (SCORAD)	A questionnaire to examine the difference in eczema severity between two arms	4 weeks
Primary	The Patient Oriented Eczema Measure (POEM)	A questionnaire to examine the difference in eczema severity between two arms	4 weeks
Primary	Nottingham Eczema Severity Score (NESS)	A questionnaire to examine the difference in eczema severity between two arms	4 weeks
Primary	The Children's Dermatology Life Quality Index (CDLQI)	A questionnaire to examine the difference in quality of life between two arms	4 weeks
Primary	Pediatric Allergic Disease Quality of Life Questionnaire (PADQLQ)	A questionnaire to examine the difference in quality of life between two arms	4 weeks
Secondary	Bacterial colonization	Investigating the presence of Staphylococcus aureus	4 weeks
Secondary	dermatological parameters on skin	Measuring the level of skin hydration, transepidermal water loss, and erythema	4 weeks
Secondary	seromarkers	Measuring the amount of Brain-derived neurotrophic factor, anti-Staphylococcal enterotoxin B antibody, Immunoglobulin E, and complete blood counts.	4 weeks