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

Queensland Institute of Dermatology0 个研究点目标入组 30 人开始时间: 2018年1月20日最近更新: 2019年2月11日

适应症

试验速览

•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

•1. Participation in any clinical trials in the last 30 days prior to screening
•2. Participant and or guardian(s) are unable to complete written questionnaires
•3. Women of childbearing potential, who are pregnant or breastfeeding or intend to become pregnant (within 2 months of completing the trial)
•4. Proven allergic contact dermatitis to merino wool by allergy patch testing
•5. Males with a clothing size greater than 2XL as determined by Investigator and/or females with clothing size greater than 18
•6. Participant is unable to wear garments for a minimum of 6 hours per day
•7. Participant has any kind of disorder that, in the opinion of the Investigator may compromise the ability of the participant or guardian to give informed consent

发起方

Queensland Institute of Dermatology