A randomized, blinded, clinical trial assessing the efficacy of superfine merino wool base layer garments (SMWBG) in children with Atopic Dermatitis (AD) measuring SCORAD, EASI, POEM and DSA scores

INTERVENTION: A with‐garment intervention phase (IP) where participants wore Superfine Marino Wool Base Layer Garments [SMWBG] for 5 weeks, was compared with pre‐garment IP and post‐garment IP where participant's normal clothing was worn. This study assessed the tolerability and potential therapeutic effect of superfine merino wool base layer garments (SMWBG) (garments worn directly against the skin) in children and young adults with atopic dermatitis (AD). We assessed the severity of AD looking at SCORAD1, EASI2, POEM3 and DSA4. CONDITION: Atopic dermatitis ; Skin and Connective Tissue Diseases ; Atopic dermatitis PRIMARY OUTCOME: The tolerability of superfine Merino wool base layer garments measured using SCORing Atopic Dermatitis (SCORAD), (Eczema Area and Severity Index), Dermatitis Severity Assessment (DSA), and Patient Orientated Eczema Measure (POEM), during the Pre‐Garment intervention Phase (5 week period with 3 visits scheduled including baseline scores), the With‐Garment intervention Phase (5 week period with 2 visits scheduled), and the Post‐Garment intervention Phase (5 week period with 2 visits scheduled) SECONDARY OUTCOME: Quality of life, measured using Dermatology Life Quality Index (DLQI), Childrens Dermatology Life Quality Index (CDLQI), Patient Orientated Eczema Measure (POEM), during the Pre‐Garment intervention Phase (5 week period with 3 visits scheduled including baseline scores), the With‐Garment intervention Phase (5 week period with 2 visits scheduled), and the Post‐Garment intervention Phase (5 week period with 2 visits scheduled) INCLUSION CRITERIA: 1. Participant and/or guardian have provided informed consent 2. Participant is of either sex and of any race/ethnicity and aged 6 to 25 years of age, at the time of screening 3. Participant has a diagnosis of dermatitis for at least six months, proven by itchy skin located, but not limited to skin creases (front of elbows, back of knees and around eyes and neck) 4. Participant's dermatitis severity should be stable with no recent hospitalisations, increased systemic steroid use or recurrent clinically significant cutaneous infections within the last 5 weeks prior to screening 5. Participant or guardian must be capable of completing written questionnaires 6. The participant must be capable of completing the procedural requirements of the protocol 7. Optional photographic collection for research purposes