Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453512
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-05-31
Brief Title:
A Study to Evaluate the Emollient Performance of Doublebase Once in the Treatment of Atopic Eczema
Sponsor:
Dermal Laboratories Ltd
Organization:
Dermal Laboratories Ltd
Study Overview
Official Title:
A Study to Evaluate the Emollient Performance of Doublebase Once in the Treatment of Atopic Eczema Using SCORAD Patient Questionnaires and Skin Hydration Measurements
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A 4 week open label multi-centre GP setting post market clinical follow-up study with Doublebase Once in patients of any age and any severity of atopic eczema
The study will involve patients who are already using emollients as part of their treatment regime switching to Doublebase Once Patients will ideally apply the product once daily for 4 weeks and SCORAD assessments will be performed and patient questionnaires will be completed A subgroup of adult patients up to 15 patients will also undergo skin hydration measurements for the first 8 days to evaluate objective measurements of skin hydration in patients with atopic eczema
Photographs of the same representative area of eczema will also be taken for all patients at baseline and after 4 weeks of using Doublebase Once
The study will involve patients who are already using emollients as part of their treatment regime switching to Doublebase Once Patients will ideally apply the product once daily for 4 weeks and SCORAD assessments will be performed and patient questionnaires will be completed A subgroup of adult patients up to 15 patients will also undergo skin hydration measurements for the first 8 days to evaluate objective measurements of skin hydration in patients with atopic eczema
Photographs of the same representative area of eczema will also be taken for all patients at baseline and after 4 weeks of using Doublebase Once
Detailed Description:
This is a prospective open label uncontrolled study which will be performed in multiple GP centres in patients of all ages who have any severity of atopic eczema It is anticipated that approximately 75 patients will need to be screened to enrol 65 eligible patients and to complete the study with 50 evaluable patients This study is being conducted as part of the manufacturers undertaking to follow up the clinical performance of the device in the post marketing phase Post Marketing Clinical Follow-up PMCF It will provide additional quantitative information on the product in a real-world environment in various age groups and severities of atopic eczema using validated assessment methods and patient feedback
Study patients will be asked to use Doublebase Once only once daily for 4 weeks instead of their usual emollient If they need to use Doublebase Once more frequently this will be recorded in their patient diaries as will any other topical or systemic treatments that they may need to use during the study period eg corticosteroids Patients will also be able to use Doublebase Once as a soap substitute
A SCORAD assessment will be performed by the investigator research nurse at baseline and then after 1 and 4 weeks of treatment Patients or their parents legal guardians will be asked to complete questionnaires at baseline and after 4 weeks of treatment
A subgroup of adult patients of up to 15 patients will have additional skin hydration measurements corneometry taken before switching emollient to Doublebase Once and on 4 more occasions during the first 8 days to evaluate changes in skin hydration in patients with atopic eczema this will be performed at the same representative predetermined selected area of eczema Measurements will be taken in triplicate and the mean calculated and each reading and the mean value will be documented in the patients CRF at baseline 24 hours after the first application and then again on days 3 5 and 8 prior to the application for that day This subgroup will then continue in the study for the SCORAD and questionnaire follow-up at the same visit timings as the rest of the study population see 71211
Photographs of one eczema affected area which will not include any recognisable or identifiable features private areas or details of the patient will also be taken at baseline and again after 4 weeks of treatment
Study patients will be asked to use Doublebase Once only once daily for 4 weeks instead of their usual emollient If they need to use Doublebase Once more frequently this will be recorded in their patient diaries as will any other topical or systemic treatments that they may need to use during the study period eg corticosteroids Patients will also be able to use Doublebase Once as a soap substitute
A SCORAD assessment will be performed by the investigator research nurse at baseline and then after 1 and 4 weeks of treatment Patients or their parents legal guardians will be asked to complete questionnaires at baseline and after 4 weeks of treatment
A subgroup of adult patients of up to 15 patients will have additional skin hydration measurements corneometry taken before switching emollient to Doublebase Once and on 4 more occasions during the first 8 days to evaluate changes in skin hydration in patients with atopic eczema this will be performed at the same representative predetermined selected area of eczema Measurements will be taken in triplicate and the mean calculated and each reading and the mean value will be documented in the patients CRF at baseline 24 hours after the first application and then again on days 3 5 and 8 prior to the application for that day This subgroup will then continue in the study for the SCORAD and questionnaire follow-up at the same visit timings as the rest of the study population see 71211
Photographs of one eczema affected area which will not include any recognisable or identifiable features private areas or details of the patient will also be taken at baseline and again after 4 weeks of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None