Atopic Eczema

This project aims to establish whether an adapted extraction device is tolerable and will be able to measure chemical signals in baby's ISF. Insight into the chemical profiles found in the skin interstitial fluid (ISF) of healthy and diseased babies will identify signals that can be used to investigate the causes of eczema and propose new preventative strategies and effective treatments. Specifically, it aims to: 1. Demonstrate that the developed ISF device can be used to extract biomarkers from the skin of babies non-invasively and is tolerable (not causing significant discomfort, bruising, or blister formation). 2. Compare the profile of chemical markers present in the ISF of healthy babies with babies that have developed eczema. 3. Compare the biomarker levels extracted from babies with eczema in lesional and non-lesional skin using the developed ISF device. 4. Compare the microbiome and metabolome profiles from swabs taken from babies with healthy skin and with eczema in lesional and non-lesional skin (exploratory outcome).

Rationale (What is the reason for this study?) Atopic dermatitis (AD) is a condition that makes the skin dry and itchy and is the most common skin condition that causes redness and irritation. The exact cause of AD is unclear but genetic and environmental factors are believed to play a role. Common treatment options for participants with AD include basic skin care, medicine that is applied to the skin, and medicine that works in more than one part of the body. Typically, these treatment options work for participants with AD but some have skin lesions (skin sores or damaged skin) over large areas of the body and do not see an improvement in their AD symptoms. MG-K10 has been shown to be effective in treating participants with moderate-to-severeatopic dermatitis in Phase 2 studies (Chaoying Gu et al.2025) and has already completed a Phase 3 clinical study for adults in China. This study aims to evaluate the efficacy and safety of MG-K10 in the adolenscents and adults with moderate-to-severeatopic dermatitis in global population. Objectives (goals of the study) and Endpoints (how goals are measured) Check how MG-K10 treatment affects atopic dermatitis Study doctors will look at the safety of MG-K10 and if any side effects are reported by participants when they take it. Check how the body processes MG-K10 Check how MG-K10 affects the biomarkers of effect Check how the body's immune system (the body's defense system) reacts to MG-K10

This randomized controlled trial (RCT) aims to evaluate the efficacy and safety of Crisaborole 2% cream compared with placebo in patients with mild to moderate atopic dermatitis (AD), also known as atopic eczema. AD is a chronic inflammatory skin condition characterized by itching, redness, and recurrent flares that can significantly impair quality of life. Eligible participants aged 12 to 50 years with mild to moderate AD will be randomly assigned to receive either Crisaborole 2% cream or a placebo cream applied twice daily for four weeks. The primary outcome is treatment success at Day 28, defined using the Investigator's Static Global Assessment (ISGA) as a score of 0 (clear) or 1 (almost clear) with at least a two-grade improvement from baseline. Participants will be evaluated at baseline, Day 14, and Day 28. Safety, tolerability, and compliance will also be assessed. The results of this RCT may provide locally relevant evidence to guide the management of mild to moderate AD.

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.