Evaluation of atopic dermatitis using a topical moisturiser containing tocotrienol
| ISRCTN | ISRCTN45468017 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45468017 |
| Secondary identifying numbers | JKEUPM-2019-274 (NMMR-19-1588-49234) |
- Submission date
- 29/08/2022
- Registration date
- 05/09/2022
- Last edited
- 09/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
Atopic dermatitis causes the skin to become itchy, dry and cracked. Little is known about the antioxidant effects of topical vitamin E on atopic dermatitis due to a lack of controlled clinical studies. Therefore this study aims to assess the effectiveness and safety of a moisturiser containing a tocotrienol-rich composition (REMDII Sensitive, Malaysia) on children with mild-to-moderate atopic dermatitis.
Who can participate?
Patients aged 1 month to 12 years with a diagnosis of atopic dermatitis
What does the study involve?
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 Intensive Moisturising Cream) and body wash (REMDII® Sensitive Calming Body Wash) given and abstain from using other soap-based products and commercial moisturiser during the whole study period. In accordance with this, participants are advised to apply the study product (Remdii Sensitive) thrice daily on the affected atopic dermatitis lesion sites for 12 consecutive weeks. To ensure their compliance, each participant is requested to return the bottles at every visit to assess the amount of applied moisturiser. Mild potency corticosteroids such as hydrocortisone 1% cream are used for the first 2 weeks concurrently with the study product. Thereafter, the use is only limited to flare up. The utilization of corticosteroids is recorded in the provided diary.
What are the possible benefits and risks of participating?
There are no adverse effects known to be caused by REMDII Sensitive. REMDII Sensitive has been registered to the National Pharmaceutical Regulatory Agency (NPRA), Kementerian Kesihatan Malaysia with the notification number NOT181000506K and certified halal. All topicals can cause irritation, burning, stinging sensation and folliculitis. There is a low risk of sensitization to the topical ingredients. The study procedures are all routine procedures for the disease/condition studied. There is thus a minimal risk for subjects. All parties will be insured by trial insurance paid for by the sponsor.
Where is the study run from?
Lipidware Sdn Bhd (Malaysia)
When is the study starting and how long is it expected to run for?
February 2019 to February 2020
Who is funding the study?
Lipidware Sdn Bhd (Malaysia)
Who is the main contact?
1. Dr How Kang Nien, hkangnien@upm.edu.my
2. Prof. Lai Oi Ming, omlai@upm.edu.my
Contact information
Principal Investigator
Dermatology Unit
Faculty of Medicine and Health Sciences
Universiti Putra Malaysia
Serdang
43400
Malaysia
 ORCID ID |
0000-0002-8032-9804 |
|---|---|
| Phone | +60 (0)17-6723051 |
| hkangnien@upm.edu.my |
Scientific
Department of Bioprocess Technology
Faculty of Biotechnology and Biomolecular Sciences
Universiti Putra Malaysia
Serdang
43400
Malaysia
| ORCID ID |
0000-0003-1205-149X |
|---|---|
| Phone | +60 (0)3-9769 7520 |
| omlai@upm.edu.my |
Study information
| Study design | Phase II open-label single-arm single-centre clinical study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 42297_PIS.pdf |
| Scientific title | 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 |
| Study acronym | Atopic Dermatitis |
| Study objectives | REMDII Sensitive significantly improves the severity of atopic dermatitis in children with mild to moderate atopic dermatitis. |
| Ethics approval(s) | Approved 27/08/2019, Universiti Putra Malaysia Ethic Committee for Research Involving Human Subjects (JKEUPM; Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia; +60 (0)3 97691605; jkeupm@upm.edu.my), ref: JKEUPM/1.4.18.2 (JKEUPM) |
| Health condition(s) or problem(s) studied | Atopic dermatitis |
| Intervention | 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 Intensive Moisturising Cream) and body wash (REMDII® Sensitive Calming Body Wash) given and abstain from using other soap-based products and commercial moisturiser during the whole study period. In accordance with this, participants are advised to apply the study product (Remdii Sensitive) thrice daily on the affected atopic dermatitis lesion sites for 12 consecutive weeks. To ensure their compliance, each participant is requested to return the bottles at every visit to assess the amount of applied moisturiser. Mild potency corticosteroids such as hydrocortisone 1% cream are used for the first 2 weeks concurrently with the study product. Thereafter, the use is only limited to flare up. The utilization of corticosteroids is recorded in the provided diary. |
| Intervention type | Other |
| Primary outcome measure | 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 | 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 |
| Overall study start date | 11/02/2019 |
| Completion date | 04/02/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Month |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 33 |
| Total final enrolment | 30 |
| Key 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 |
| Key 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 <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 |
| Date of first enrolment | 01/07/2019 |
| Date of final enrolment | 30/08/2019 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Serdang
43400
Malaysia
Sponsor information
Industry
MTDC-UPM, G-05
Jalan Maklumat
Universiti Putra Malaysia
Serdang
43400
Malaysia
| Phone | +60 (0)17 331 9765 |
|---|---|
| m2leow@lipidware.com | |
| Website | https://remdii.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/11/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to anonymity arrangements made with the patients that data of personal nature will be made anonymous as much as possible. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 01/09/2022 | No | Yes | ||
| Protocol file | 01/09/2022 | No | No | ||
| Results article | 04/05/2023 | 09/05/2023 | Yes | No |
Additional files
Editorial Notes
09/05/2023: Publication reference added.
01/09/2022: Trial's existence confirmed by the Universiti Putra Malaysia Ethic Committee for Research Involving Human Subject.
