Evaluation of atopic dermatitis using a topical moisturiser containing tocotrienol
- Conditions
- Atopic dermatitisSkin and Connective Tissue Diseases
- Registration Number
- ISRCTN45468017
- Lead Sponsor
- ipidware Sdn Bhd
- Brief Summary
2023 Results article in https://doi.org/10.1111/jocd.15793 (added 09/05/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
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 Infections which are not deemed related to atopic eczema i.e. pneumonia, UTI, AGE, will not be withdrawn even if fulfilled sepsis criteria.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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Atopic dermatitis severity measured using Investigator's Global Assessment (IGA) score at baseline, Week 0, Week 2, Week, 4, Week 8 and Week 12
- Secondary Outcome Measures
Name Time Method