Clinical trial NCT04986384: Effect of a Topical Spray on Itch Relief in Moderate-to-severe Childhood Eczema
Official title: Effect of a Topical Spray on Itch Relief in Moderate-to-severe Childhood Eczema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eczema
Keywords: itch relief
childhood
eczema
topical spray
quality of life
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 40
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: SCORing Atopic Dermatitis (SCORAD)
timeFrame: 4 weeks
measure: The Patient Oriented Eczema Measure (POEM)
timeFrame: 4 weeks
measure: Nottingham Eczema Severity Score (NESS)
timeFrame: 4 weeks
measure: The Children's Dermatology Life Quality Index (CDLQI)
timeFrame: 4 weeks
measure: Pediatric Allergic Disease Quality of Life Questionnaire (PADQLQ)
timeFrame: 4 weeks
Secondary outcomes:
measure: Bacterial colonization
timeFrame: 4 weeks
measure: dermatological parameters on skin
timeFrame: 4 weeks
measure: seromarkers
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Paediatrics, The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Kam Lun Ellis KL Hon, MD, MBBS
role: PRINCIPAL_INVESTIGATOR
References: