Effect of a Topical Spray on Itch Relief in Moderate-to-severe Childhood Eczema
Primary Purpose
Eczema
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Atoderm SOS spray Aerosol 200ml
Sponsored by
About this trial
This is an interventional treatment trial for Eczema focused on measuring itch relief, childhood, eczema, topical spray, quality of life
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
Sites / Locations
- Department of Paediatrics, The Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Active Treatment Group
Wait-list Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
SCORing Atopic Dermatitis (SCORAD)
A questionnaire to examine the difference in eczema severity between two arms
The Patient Oriented Eczema Measure (POEM)
A questionnaire to examine the difference in eczema severity between two arms
Nottingham Eczema Severity Score (NESS)
A questionnaire to examine the difference in eczema severity between two arms
The Children's Dermatology Life Quality Index (CDLQI)
A questionnaire to examine the difference in quality of life between two arms
Pediatric Allergic Disease Quality of Life Questionnaire (PADQLQ)
A questionnaire to examine the difference in quality of life between two arms
Secondary Outcome Measures
Bacterial colonization
Investigating the presence of Staphylococcus aureus
dermatological parameters on skin
Measuring the level of skin hydration, transepidermal water loss, and erythema
seromarkers
Measuring the amount of Brain-derived neurotrophic factor, anti-Staphylococcal enterotoxin B antibody, Immunoglobulin E, and complete blood counts.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04986384
Brief Title
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
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 24, 2019 (Actual)
Primary Completion Date
April 7, 2021 (Actual)
Study Completion Date
April 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. HON Kam Lun Ellis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eczema
Keywords
itch relief, childhood, eczema, topical spray, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Treatment Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Wait-list Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Atoderm SOS spray Aerosol 200ml
Intervention Description
A bottle of 200ml topical spray was used on the eczematous skin lesions for itch relief.
Primary Outcome Measure Information:
Title
SCORing Atopic Dermatitis (SCORAD)
Description
A questionnaire to examine the difference in eczema severity between two arms
Time Frame
4 weeks
Title
The Patient Oriented Eczema Measure (POEM)
Description
A questionnaire to examine the difference in eczema severity between two arms
Time Frame
4 weeks
Title
Nottingham Eczema Severity Score (NESS)
Description
A questionnaire to examine the difference in eczema severity between two arms
Time Frame
4 weeks
Title
The Children's Dermatology Life Quality Index (CDLQI)
Description
A questionnaire to examine the difference in quality of life between two arms
Time Frame
4 weeks
Title
Pediatric Allergic Disease Quality of Life Questionnaire (PADQLQ)
Description
A questionnaire to examine the difference in quality of life between two arms
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Bacterial colonization
Description
Investigating the presence of Staphylococcus aureus
Time Frame
4 weeks
Title
dermatological parameters on skin
Description
Measuring the level of skin hydration, transepidermal water loss, and erythema
Time Frame
4 weeks
Title
seromarkers
Description
Measuring the amount of Brain-derived neurotrophic factor, anti-Staphylococcal enterotoxin B antibody, Immunoglobulin E, and complete blood counts.
Time Frame
4 weeks
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kam Lun Ellis KL Hon, MD, MBBS
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Paediatrics, The Chinese University of Hong Kong
City
Hong Kong
ZIP/Postal Code
00000
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The IPD involved sensitive clinical information which was regarded as patients' privacy. The overall study results could be found in published journal.
Learn more about this trial
Effect of a Topical Spray on Itch Relief in Moderate-to-severe Childhood Eczema
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