EczemaNCT04986384
Effect of a Topical Spray on Itch Relief in Moderate-to-severe Childhood Eczema
A study testing Atoderm SOS spray Aerosol 200ml in people with Eczema, run by Prof. HON Kam Lun Ellis at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Eczema
- What is being tested?
- Atoderm SOS spray Aerosol 200ml
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 24 Jan 2019to 7 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- No history of known eczema
- Concurrently participating into another clinical trial
- History of known drug allergy
- unable to read Chinese
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Paediatrics, The Chinese University of Hong Kong
Hong Kong, 00000
About this study
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
- Being tested
- Atoderm SOS spray Aerosol 200ml
- Keywords
- itch relief, childhood, eczema, topical spray, quality of life
- Medical subject headings
- Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atoderm SOS spray Aerosol 200mlDrug
A bottle of 200ml topical spray was used on the eczematous skin lesions for itch relief.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Atoderm SOS spray Aerosol 200ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCORing Atopic Dermatitis (SCORAD)
A questionnaire to examine the difference in eczema severity between two arms
Measured: 4 weeks
The Patient Oriented Eczema Measure (POEM)
A questionnaire to examine the difference in eczema severity between two arms
Measured: 4 weeks
Nottingham Eczema Severity Score (NESS)
A questionnaire to examine the difference in eczema severity between two arms
Measured: 4 weeks
The Children's Dermatology Life Quality Index (CDLQI)
A questionnaire to examine the difference in quality of life between two arms
Measured: 4 weeks
Pediatric Allergic Disease Quality of Life Questionnaire (PADQLQ)
A questionnaire to examine the difference in quality of life between two arms
Measured: 4 weeks
Secondary outcomes (3)
Bacterial colonization
Investigating the presence of Staphylococcus aureus
Measured: 4 weeks
dermatological parameters on skin
Measuring the level of skin hydration, transepidermal water loss, and erythema
Measured: 4 weeks
seromarkers
Measuring the amount of Brain-derived neurotrophic factor, anti-Staphylococcal enterotoxin B antibody, Immunoglobulin E, and complete blood counts.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start24 Jan 2019
- Primary completion7 Apr 2021
- Study completion7 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. HON Kam Lun Ellis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. HON Kam Lun Ellis, Chinese University of Hong Kong
- Investigators
- Kam Lun Ellis KL Hon, MD, MBBS, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986384
- Sponsor's protocol ID
- BAIS2018
- Status last verified
- May 2021
- First submitted
- 29 May 2021
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD involved sensitive clinical information which was regarded as patients' privacy. The overall study results could be found in published journal.
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Topical Spray on Itch Relief in Moderate-to-severe Childhood Eczema
- ClinicalTrials.gov ID
- NCT04986384
- Acronym / sponsor ID
- BAIS2018
- Conditions
- Eczema
- Keywords
- itch relief, childhood, eczema, topical spray, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Prof. HON Kam Lun EllisUniversity, hospital or other
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 7 Apr 2021 (actual)
- Study completion
- 7 Apr 2021 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment Group | Active comparator | Drug: Atoderm SOS spray Aerosol 200mlPatients 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. |
| Wait-list Control Group | Active comparator | Drug: Atoderm SOS spray Aerosol 200mlPatients 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- No history of known eczema
- Concurrently participating into another clinical trial
- History of known drug allergy
- unable to read Chinese
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atoderm SOS spray Aerosol 200mlA bottle of 200ml topical spray was used on the eczematous skin lesions for itch relief. | Drug | Active Treatment Group, Wait-list Control Group |
Primary outcome
SCORing Atopic Dermatitis (SCORAD)
Time frame: 4 weeks
A questionnaire to examine the difference in eczema severity between two arms
The Patient Oriented Eczema Measure (POEM)
Time frame: 4 weeks
A questionnaire to examine the difference in eczema severity between two arms
Nottingham Eczema Severity Score (NESS)
Time frame: 4 weeks
A questionnaire to examine the difference in eczema severity between two arms
The Children's Dermatology Life Quality Index (CDLQI)
Time frame: 4 weeks
A questionnaire to examine the difference in quality of life between two arms
Pediatric Allergic Disease Quality of Life Questionnaire (PADQLQ)
Time frame: 4 weeks
A questionnaire to examine the difference in quality of life between two arms
3 secondary outcomes
Bacterial colonization
Time frame: 4 weeks
dermatological parameters on skin
Time frame: 4 weeks
seromarkers
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Individual participant dataSharing planned: No. The IPD involved sensitive clinical information which was regarded as patients' privacy. The overall study results could be found in published journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kam Lun Ellis KL Hon, MD, MBBS principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atoderm SOS spray Aerosol 200ml in people with Eczema, run by Prof. HON Kam Lun Ellis at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCORing Atopic Dermatitis (SCORAD) (time frame: 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.