A Phase II open-label, single arm, single centre clinical study on the effect of a moisturiser containing tocotrienol-rich composition on mild to moderate atopic dermatitis in children

ipidware Sdn Bhd0 个研究点目标入组 30 人开始时间: 2022年9月5日最近更新: 2023年5月22日

适应症

试验速览

2023 Results article in https://doi.org/10.1111/jocd.15793 (added 09/05/2023)

•1. Male and female ages 1 month to 12 years with a diagnosis of atopic dermatitis based on UK Working Party Criteria of Atopic Dermatitis (Williams, Jburney, Pembroke, Hay, & Party, 1994)
•2. Individuals with an IGA score of at least mild (IGA= 2) or moderate (IGA= 3) and have at least 5% of body surface area affected during the inclusion time
•3. Individuals with a carer reported pruritus score based on VAS of at least 40 mm and above

•1. Patients with exacerbation which is not controlled by per protocol rescue medicine in 2 weeks.
•2. Infection failed to be treated with per protocol oral antibiotic. Or those who develop cutaneous sepsis, as defined by skin infection + >/= 2 meets the SIRS definition, as defined below:
•3. Temp >38.5°C or >36°C
•4. Tachycardia or bradycardia (if <1 year)
•5. Tachypnea or requiring mechanical ventilation
•6. Abnormal leukocyte count or >10% bands
•7. Infections which are not deemed related to atopic eczema i.e. pneumonia, UTI, AGE, will not be withdrawn even if fulfilled sepsis criteria.
•8. The development of any severe adverse event, as defined by the Malaysian GCP
•9. Use of any forbidden medication or treatment, and/or other use moisturisers or emollients during the trial that could affect the study result
•10. Subjects who did not comply with the protocol of at least two times-per-day application of cream
•11. Subject’s withdrawal of consent
•12. Detection of eligibility violations, occurrence of other significant protocol violations during the trial
•13. Investigator’s decision to terminate the process for the sake of the subject’s health
•14. Dropouts are defined as patients who did not attend a follow-up visit within the designated visit window (+/- 3 days) and whose outcomes are unknown by the end of the trial

发起方

ipidware Sdn Bhd