Atopic dermatitis Skin and Connective Tissue Diseases Atopic dermatitis
Conditions
Interventions
Each participant will be examined for signs and symptoms of atopic dermatitis before and after using REMDII Sensitive. Participants are instructed to exclusively use the moisturiser (REMDII® Sensitive
Sponsors
Lipidware Sdn Bhd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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 Infections which are not deemed related to atopic eczema i.e. pneumonia, UTI, AGE, will not be withdrawn even if fulfilled sepsis criteria. 8.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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. Atopic dermatitis severity measured using Scoring Atopic Dermatitis Index (SCORAD) at baseline, Week 0, Week 2, Week, 4, Week 8 and Week 12 2. Atopic dermatitis severity measured using Infant Dermatology Life Quality Index (IDQOL) and Children's Dermatology Life Quality Index (CDLQI) at baseline, Week 0, Week 2, Week, 4, Week 8 and Week 12 3. Atopic dermatitis severity measured using Pruritis Score using Visual Analogue Score (VAS) or ordinal at baseline, Week 0, Week 2, Week, 4, Week 8 and Week 12 4. Frequency of rescue treatment needed, measured using the number of times hydrocortisone is required at baseline, weeks 0, 2, 4, 8 and 12 5. Atopic dermatitis severity measured using high-resolution ultrasound skin imaging (HR-USI), skin colour and transepidermal water loss (TEWL) at baseline, Week 0, Week 2, Week, 4, Week 8 and Week 12 6. Correlation between atopic dermatitis severity measured using SCORAD index and Patient-Oriented SCORing Atopic Dermatitis (PO-SCORAD) or IDLQI at each baseline and follow-up visit at weeks 0, 2, 4, 8 and 12 and absolute changes from baseline | — |
Countries
Malaysia
Outcome results
None listed