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

NCT ID: NCT04986384

Last Updated: 2021-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-24
• Study Completion Date: 2021-04-07

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.

Conditions

Eczema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Atoderm SOS spray Aerosol 200ml

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Atoderm SOS spray Aerosol 200ml

Intervention Type: DRUG

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

Interventions

Atoderm SOS spray Aerosol 200ml

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

Intervention Type: DRUG

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prof. HON Kam Lun Ellis

OTHER

Sponsor Role: lead

Responsible Party

Prof. HON Kam Lun Ellis

Department of Paediatrics, 6/F, Lui Chee Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kam Lun Ellis KL Hon, MD, MBBS

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Department of Paediatrics, The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

BAIS2018

Identifier Type: -

Identifier Source: org_study_id