Atopic Dermatitis / Eczema
Conditions
Interventions
Gladskin eczema cream
Sponsors
Micreos Human Health
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: For enrollment of subjects the following criteria must be met: 1. Male and female subjects with mild to moderate AD (IGA 2 or 3) 18 to 55 years of age, inclusive. The health status is verified by absence of evidence of any clinically significant active or uncontrolled chronic disease other than AD following a detailed medical history and a complete physical examination 2. Diagnosed with AD according to the Hanifin criteria 3. EASI *4 4. Suitable target lesion defined as an eczema lesion of at least 1% BSA (preferably the antecubital fossa) with at least mild erythema and mild induration 5. *5% body surface area (BSA) affected at screening and baseline 6. Willing to not wash the target lesion 12 hours before every study visit 7. Willing to use microbiome friendly wash solution and refrain from other products for washing from screening until end-of-study 8. Able to participate and willing to give written informed consent and to comply with the study restrictions 9. Has sufficient Dutch language skills to be able to communicate well with the Investigator, understand the informed consent and complete questionnaires and e-diary.
Exclusion criteria
Exclusion criteria: 1. Any current and / or recurrent clinically significant skin condition other than AD 2. Ongoing use of prohibited atopic dermatitis treatments. Washout periods prior to baseline (first dose of the study medical device) are as follows: a. Any topical medication (prescription or over-the-counter [OTC]): 14 days. Continued use of emollients during wash-out is allowed. b. Cyclosporine/oral steroids/azathioprine/mycophenolate mofetil/other systemic AD treatments: 4 weeks c. Phototherapy: 3 weeks d. Biologics: 5 half-lives of the drug e. Systemic antibiotics: 14 days 3. Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrolment 4. Known hypersensitivity to the compound or excipients of the compound 5. Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding; 6. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year 7. Any (medical) condition that would, in the opinion of the investigator, potentially compromise the safety or compliance of the patient or may preclude the patient*s successful completion of the clinical trial. 8. Subject has a body temperature of >38°C at any visit;.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability / safety endpoints Adverse events (AE) will be collected throughout the study, at every study visit. Pharmacodynamic endpoints Pharmacodynamic effects of Gladskin will be assessed at the time points indicated in the Visit and Assessment Schedule (Table 1) by: - Multispectral imaging (erythema and roughness of target lesion) - Laser speckle contrast imaging (LSCI, blood flow of target lesion) - Microbiome of skin lesions (of target lesion and non-lesional skin) - Bacterial colonization of skin lesions (S. aureus cultures of target lesion and non-lesional skin) - Local (biopsy) biomarkers may comprise, but are not limited to: IL-13, IL-4, IL-5, IL-33, TSLP, IL-31, IL-22, eotaxin - Transepidermal water loss of lesional and non-lesional skin Efficacy endpoints Efficacy will be assessed at the time points indicated in the Visit and Assessment Schedule (Table 1): - Clinical assessment using oSCORAD; EASI, IGA - Target lesion oSCORAD and Total Signs and Symptoms (TSS) - Patient-reported itch (daily NRS by ediary(app) and POEM) - Dermatology Life Quality Index (DLQI) - Standardized total body clinical photography - Electronic diary for medical device compliance and use of escape medication | — |
Secondary
| Measure | Time frame |
|---|---|
| N.A. | — |
Countries
Netherlands
Outcome results
None listed