Atopic EczemaNCT05454722
A Study to Evaluate Adex Gel in the Treatment of Atopic Eczema.
A study testing ADEX Gel in people with Atopic Eczema, run by Dermal Laboratories Ltd at 2 sites in United Kingdom.
Trial summary
This is a prospective, open label, uncontrolled study which will be performed in multiple Primary Care (GP) centres, in approximately 60 children (aged 1 year to 15 years) who have moderate atopic eczema and who are not currently using oral or topical corticosteroids or immunomodulators and have not used them in the… Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Atopic Eczema
- What is being tested?
- ADEX Gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 16 Nov 2022to 28 Mar 2024
- 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 1 year to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female.
- Aged between 1 year and 15 years.
- Patients with atopic eczema (personal or combined personal and familial atopy), of moderate severity in accordance with the NICE categorisation
- SCORAD assessment score of between 25 to 50.
- Minimum score of 6 on the CDLQI (QoL).
- Patients or their parents/ legal guardians must be able to read and understand the patient information sheet and sign the consent form.
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- Patients normally managing their eczema by regular and ongoing use of leave-on emollient(s), or new atopic eczema sufferers, who have not been using oral or topical corticosteroids, Adex Gel or immunomodulators for the last month.
- Patients who are willing to use only Adex Gel for 4 weeks.
- Patients who are willing to continue to use their standard wash regime for the duration of the study. This will be documented at the initial visit.
Who cannot join
- Under 1 year of age or over 15 years and 11 months at screening.
- Are currently using or have used in the past month, any oral or topically applied corticosteroids, Adex Gel or immunomodulators for their atopic eczema.
- Have a known history of intolerance or skin sensitivity to any of the ingredients of Adex Gel (as identified on the patient information sheet and product labelling), or similar products.
- Have mild eczema.
- Have severe or potentially infected eczema.
- Participating in other ongoing studies or have participated in a study in the previous 30 days.
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- Patients, or their parents/ legal guardians, who may have difficulties completing the quality-of-life questionnaire, which will be written in English only.
- Employees of the Sponsor or Investigators, or any immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of such employees.
- Patients with any medical condition which, in the opinion of the Investigator, may adversely influence their participation in the study.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Atherstone Surgery
Atherstone, Warwickshire, CV9 1EU
Cripps Health Centre
Nottingham, Nottinghamshire
About this study
Official title: A Study to Evaluate the Performance of Adex Gel in the Treatment of Atopic Eczema Using SCORAD and Quality of Life Assessments.
This is a prospective, open label, uncontrolled study which will be performed in multiple Primary Care (GP) centres, in approximately 60 children (aged 1 year to 15 years) who have moderate atopic eczema and who are not currently using oral or topical corticosteroids or immunomodulators and have not used them in the previous month.
Study patients will be asked to use Adex Gel three times daily, for 4 weeks instead of their usual emollient or as the first treatment for their condition, and without supplementary use of any oral or topical steroids or immunomodulators (unless this becomes unavoidable, see section 4.6.3). The Scoring Atopic Dermatitis (SCORAD) assessment will be performed by the investigator/ research nurse at baseline and then after 2 and 4 weeks of treatment. Patients or their parents/ guardians will be asked to complete the quality-of-life questionnaires (Children's Dermatology Life Quality Index (CDLQI) at baseline and after 4 weeks of treatment. Photographs, which will not include any identifiable features or details of the patient, of one eczema affected area will also be taken at baseline and again 4 weeks after treatment.
Read the detailed description
Patients will be recruited by the General Practitioner (GP) surgeries using their databases to identify patients who are currently atopic eczema sufferers and are using mainly emollients (other than Adex Gel) to manage their condition. Patients or their parents/guardians will be contacted by the surgery to see if they would like to participate in this study and to establish whether they are currently or have been using oral or topical corticosteroids or other immunomodulators in the previous 1 month. Advertisements in the surgery may also be used as these may encourage new eczema sufferers to ask the doctor if they could participate in this study. As new eczema patients they would not currently be using steroids for their condition so would be deemed eligible for screening.
Patients and their parents/legal guardians will attend the screening and enrolment visit where parents/legal guardians will be asked to sign an informed consent form, and where appropriate the participant will sign an assent form, confirming their agreement to take part in the study. A number of questions will be asked about medical history and current medications as well as eligibility criteria. No washout period will be implemented.
Those who are considered eligible to participate in accordance with the inclusion and exclusion criteria given in section 4.6, will then undergo their baseline assessments where the Investigator/ research nurse will perform the SCORAD assessments and record these in the patient's paper Case Report Form (CRF). The patient or their parent/ guardian will also complete a baseline quality of life questionnaire (CDLQI) and photographs will also be taken.
The patients will then be given sufficient supplies of Adex Gel (depending on the coverage of their eczema) to use over the 4 week use period (additional packs may be provided at visit 2, if necessary). They will be asked to use Adex Gel instead of their usual emollient (if already using one) and to try and refrain from using oral or topical corticosteroids, or immunomodulators for the duration of the study. If, in the opinion of the investigator, it becomes necessary for patients to use oral or topical corticosteroids or immunomodulators during the study, the Investigator/ research nurse will record this on their CRF, and the patient will be withdrawn from the study. Patients will be asked to record use of any other medication or topical products during the study in their Patient Diary.
After 2 weeks of treatment, patients will return to the GP surgery and will be asked about their compliance with the study requirements, changes in health and medications and any incidents will be recorded. They will again have their eczema assessed by the Investigator/ research nurse and the results recorded on the CRF.
After 4 weeks of treatment, patients will return to the surgery, where again they will be asked about compliance, changes in health and medications and any incidents will be recorded. They will also undergo their final Investigator/ research nurse assessment, have the area, which was selected at baseline, photographed, and complete the final quality-of-life questionnaire.
This visit will conclude their participation in the study unless follow-up of any incidents is required.
- Conditions
- Atopic Eczema
- Being tested
- ADEX Gel
- Keywords
- SCORAD, CDLQI, QoL
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADEX GelDevice
Emollient Gel with added anti-inflammatory
| Study group | Role | What they receive |
|---|---|---|
| Adex Gel | Experimental | Dry Skin Emollient with Nicotinamide Receives: Device: ADEX Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCORAD
Change in SCORAD (SCORing Atopic Dermatitis, based on Area, Intensity and Subjective score. (Score of 0-103 with the higher the score the more severe the condition)) over 4 weeks.
Measured: 4 weeks
QoL
Change in CDLQI (Child Dermatology Quality of Life Index (a maximum score of 30 and a minimum score of 0. The higher the score, the more quality of life is effected)) over 4 weeks
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 posted12 Jul 2022
- Study start16 Nov 2022
- Primary completion28 Mar 2024
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dermal Laboratories Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454722
- Sponsor's protocol ID
- DENI-06
- Status last verified
- May 2024
- First submitted
- 7 Jul 2022
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Performance of Adex Gel in the Treatment of Atopic Eczema Using SCORAD and Quality of Life Assessments.
- ClinicalTrials.gov ID
- NCT05454722
- Acronym / sponsor ID
- DENI-06
- Conditions
- Atopic Eczema
- Keywords
- SCORAD, CDLQI, QoL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dermal Laboratories LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 12 Jul 2022 (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.
This is a prospective, open label, uncontrolled study which will be performed in multiple Primary Care (GP) centres, in approximately 60 children (aged 1 year to 15 years) who have moderate atopic eczema and who are not currently using oral or topical corticosteroids or immunomodulators and have not used them in the previous month.
Study patients will be asked to use Adex Gel three times daily, for 4 weeks instead of their usual emollient or as the first treatment for their condition, and without supplementary use of any oral or topical steroids or immunomodulators (unless this becomes unavoidable, see section 4.6.3). The Scoring Atopic Dermatitis (SCORAD) assessment will be performed by the investigator/ research nurse at baseline and then after 2 and 4 weeks of treatment. Patients or their parents/ guardians will be asked to complete the quality-of-life questionnaires (Children's Dermatology Life Quality Index (CDLQI) at baseline and after 4 weeks of treatment. Photographs, which will not include any identifiable features or details of the patient, of one eczema affected area will also be taken at baseline and again 4 weeks after treatment.
Detailed description
Patients will be recruited by the General Practitioner (GP) surgeries using their databases to identify patients who are currently atopic eczema sufferers and are using mainly emollients (other than Adex Gel) to manage their condition. Patients or their parents/guardians will be contacted by the surgery to see if they would like to participate in this study and to establish whether they are currently or have been using oral or topical corticosteroids or other immunomodulators in the previous 1 month. Advertisements in the surgery may also be used as these may encourage new eczema sufferers to ask the doctor if they could participate in this study. As new eczema patients they would not currently be using steroids for their condition so would be deemed eligible for screening.
Patients and their parents/legal guardians will attend the screening and enrolment visit where parents/legal guardians will be asked to sign an informed consent form, and where appropriate the participant will sign an assent form, confirming their agreement to take part in the study. A number of questions will be asked about medical history and current medications as well as eligibility criteria. No washout period will be implemented.
Those who are considered eligible to participate in accordance with the inclusion and exclusion criteria given in section 4.6, will then undergo their baseline assessments where the Investigator/ research nurse will perform the SCORAD assessments and record these in the patient's paper Case Report Form (CRF). The patient or their parent/ guardian will also complete a baseline quality of life questionnaire (CDLQI) and photographs will also be taken.
The patients will then be given sufficient supplies of Adex Gel (depending on the coverage of their eczema) to use over the 4 week use period (additional packs may be provided at visit 2, if necessary). They will be asked to use Adex Gel instead of their usual emollient (if already using one) and to try and refrain from using oral or topical corticosteroids, or immunomodulators for the duration of the study. If, in the opinion of the investigator, it becomes necessary for patients to use oral or topical corticosteroids or immunomodulators during the study, the Investigator/ research nurse will record this on their CRF, and the patient will be withdrawn from the study. Patients will be asked to record use of any other medication or topical products during the study in their Patient Diary.
After 2 weeks of treatment, patients will return to the GP surgery and will be asked about their compliance with the study requirements, changes in health and medications and any incidents will be recorded. They will again have their eczema assessed by the Investigator/ research nurse and the results recorded on the CRF.
After 4 weeks of treatment, patients will return to the surgery, where again they will be asked about compliance, changes in health and medications and any incidents will be recorded. They will also undergo their final Investigator/ research nurse assessment, have the area, which was selected at baseline, photographed, and complete the final quality-of-life questionnaire.
This visit will conclude their participation in the study unless follow-up of any incidents is required.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adex Gel | Experimental | Device: ADEX GelDry Skin Emollient with Nicotinamide |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Male or female.
- Aged between 1 year and 15 years.
- Patients with atopic eczema (personal or combined personal and familial atopy), of moderate severity in accordance with the NICE categorisation
- SCORAD assessment score of between 25 to 50.
- Minimum score of 6 on the CDLQI (QoL).
Key exclusion criteria (9 listed)
- Under 1 year of age or over 15 years and 11 months at screening.
- Are currently using or have used in the past month, any oral or topically applied corticosteroids, Adex Gel or immunomodulators for their atopic eczema.
- Have a known history of intolerance or skin sensitivity to any of the ingredients of Adex Gel (as identified on the patient information sheet and product labelling), or similar products.
- Have mild eczema.
- Have severe or potentially infected eczema.
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 |
|---|---|---|
| ADEX GelEmollient Gel with added anti-inflammatory | Device | Adex Gel |
Primary outcome
SCORAD
Time frame: 4 weeks
Change in SCORAD (SCORing Atopic Dermatitis, based on Area, Intensity and Subjective score. (Score of 0-103 with the higher the score the more severe the condition)) over 4 weeks.
QoL
Time frame: 4 Weeks
Change in CDLQI (Child Dermatology Quality of Life Index (a maximum score of 30 and a minimum score of 0. The higher the score, the more quality of life is effected)) over 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 17 May 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADEX Gel in people with Atopic Eczema, run by Dermal Laboratories Ltd at 2 sites in United Kingdom.
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 9 inclusion and 9 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 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
SCORAD (time frame: 4 weeks). The study lists 2 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 17 May 2024.