Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05454722 |
| Other study ID # |
DENI-06 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 16, 2022 |
| Est. completion date |
March 28, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Dermal Laboratories Ltd |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
