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

NCT04986384 | Completed DMC

• 1 other identifier: BAIS2018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

itch relief; childhood; eczema; topical spray; quality of life

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Bacterial colonization

  4 weeks

• dermatological parameters on skin

  4 weeks

• seromarkers

  4 weeks

Study Arms (2)

Active Treatment Group

ACTIVE COMPARATOR

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

Wait-list Control Group

ACTIVE COMPARATOR

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

Interventions

Atoderm SOS spray Aerosol 200ml DRUG

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

Active Treatment Group; Wait-list Control Group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• No history of known eczema
• Concurrently participating into another clinical trial
• History of known drug allergy
• unable to read Chinese

Sponsors & Collaborators

• Prof. HON Kam Lun Ellis: lead

Study Sites (1)

Department of Paediatrics, The Chinese University of Hong Kong

Hong Kong, 00000, Hong Kong

Location

MeSH Terms

Conditions

Eczema

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Officials

• Kam Lun Ellis KL Hon, MD, MBBS

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Paediatrics, 6/F, Lui Chee Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

Study Record Dates

• First Submitted: May 29, 2021
• First Posted: August 2, 2021
• Study Start: January 24, 2019
• Primary Completion: April 7, 2021
• Study Completion: April 7, 2021
• Last Updated: August 2, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)