Is 100% Pure Stabilized Whole Rice Bran (SWRB) Effective When Used as a Cleanser and an Emollient in Patients With Mild to Moderate Atopic Dermatitis?
Phase: EARLY_PHASE1
Conditions: Dermatitis, Atopic
Sponsor: RCSI & UCD Malaysia Campus

1 
Study protocol for Investigator Initiated Research 
(Version 2 – September 15, 2020) 
Title 
Is 100% pure Stabilized Whole Rice Bran (SWRB) effective when 
used as a cleanser and an emollient in patients with mild to 
moderate atopic dermatitis? 
Principal Investigator (PI) 
Dato’ Dr S Sellappan  
Loh Guan Lye Specialist 
Centre 238, Jalan Macalister 
10400 George Town, 
Pulau Pinang 
Co-investigator 
Dr Harinarayan Radhakrishna 
RCSI & UCD Malaysia Campus 
4 Jalan Sepoy Lines 
10450 Pulau Pinang 
Aim 
To study whether the natural product, SWRB, is effective to control the 
symptoms and signs of mild to moderate Atopic Dermatitis (AD) 
Literature review & study proposal 
This clinical trial serves to look at the effectiveness of SWRB for the treatment of 
mild to moderate Atopic Dermatitis in patients below the age of 18.   
1.
Atopic Dermatitis is a common condition seen in dermatology, paediatric
and primary care clinics in Malaysia. The overall prevalence of Atopic
Dermatitis in the paediatric population in Malaysia was shown to be
around 13.4% in 2018 (Goh et al., 2018)
2. AD poses a significant biopsychosocial burden among sufferers and their
families. (Carroll et al., 2005). Current management patterns of AD
sufferers in South-east Asia mainly involve use of topical moisturizers and
topical corticosteroids (Chan et al., 2006).
3. There are many concerns among parents of sufferers of AD regarding the
side effects of these therapies, causing them to seek alternative therapies
(Lee and Bielory, 2010).
4. Many emollients are available in the market which are either occlusives,
hemectants or both. There are also bath emollients and directly applied
ones. Very little has been studied regarding their effectiveness. Emollients

2 
available may also contain preservatives and fragrances that can prove to 
be irritants when applied topically (Rubel et al., 2013).  
5. Rice bran and products derived from it have been studied regarding their
anti-oxidant, nutritional, cholesterol lowering and health promoting
properties (Nagendra Prasad et al., 2011).
However, there are very few studies that have focused on the benefits of SWRB 
when used topically.  
6. One study had used rice bran broth bath therapy in patients with Atopic
Dermatitis, with positive results (Fujiwaki and Furusho, 1992).
SWRB is cost-effective and easily available, while being an under-utilised 
product. We wanted to study its effectiveness in controlling the signs and 
symptoms of Atopic Dermatitis when used as a cleanser and topical paste 
(emollient) as very little is known on this subject. 
Methodology / Protocol 
This is a clinical trial involving topical therapy with pure SWRB which is in 
powder form, on patients below 18 years of age, who suffer from mild to 
moderate atopic dermatitis.  
The SWRB is from locally grown rice and locally milled rice bran.  This has been 
recently stabilised, for the first time in Malaysia, and made suitable for human 
use by Rice Bran Nutraceuticlas Sdn. Bhd. 
The SWRB is provided Free of Charge for this Study by RBN 
Sample size: The proposed sample size is 50-100 patients of the 
abovementioned age group. 
The severity of disease in the selected sample will be assessed using the widely 
used SCORAD index. 
Patients will be selected from out-patient clinics of 
•
Dato’ Dr S Sellappan’s clinic at Loh Guan Lye Specialist Centre.
•
Klinik Derma Sivasantha at 11, Jalan Sungai. 10150 Pulau Pinang.
•
Any other Doctor or Clinic who is interested in participating in this study.
Written consent to participate in this study will be obtained from the 
parent/guardian via a consent form, which includes Information Leaflet for the 
Parent/Guardian and Participant as well as Instructions to Patients for Use of SWRB 
as cleanser or as moisturiser 
Assent from the subjects from the ages from 8 to below 18 will be obtained using 
the assent form attached.  Both, the consent and the assent forms will be 
attached to the child’s medical records.  
Confidentiality of patient information and anonymity will be maintained at all 
times. 

3 
Inclusion criteria:  
Patients below 18 years of age with mild and moderate Atopic Dermatitis 
 
 
Exclusion criteria:  
1. Those over 18 years of age 
 
2. Patients with other forms of dermatitis 
3. Severe disease 
 
4. Those already on other forms of topical therapies, which are likely to interfere 
with outcomes 
 
 
Proposed intervention: 
Patients with mild AD will be given SWRB in powder form, to be used as a 
cleanser after adding water to it according to set proportions given as 
instructions, one time per day. 
Patients with moderate disease will be instructed to use SWRB as a cleanser as 
above. In addition, they will also use SWRB as an emollient after constituting it 
into a paste as in instructions, apply at night and leave it overnight. 
This study does not involve any enteral or parenteral administration of SWRB. 
Neither does it involve any invasive procedures. 
 
 
Management of adverse effects of SWRB 
Adverse reaction is very unlikely as this is a 100% rice- based product with no 
bacterial growth or heavy metals. The only rare adverse effect that might occur is 
allergy to the protein in SWRB causing an increase in the rash. Should this occur, 
the investigator will undertake the following measures: 
1. Withdraw the SWRB. 
2. Withdraw the patient from the study. 
3. Initiate symptomatic treatment. 
4. Administer oral anti-histamine if indicated. 
5. Treat with topical corticosteroid if indicted. 
6. Follow-up the child every 2 days till adverse effect is controlled. 
 
 
Data collection 
The patients will be followed up for four to six (4 - 6) weeks and the clinical 
features tabulated . Where appropriate, photographs of the lesion/s will be taken 
for evaluation of progression / regression at the end of the study, while 
protecting the identity of the patient. 
A questionnaire using the Likert scale, will be prepared for the patient’s parent/s 
to complete. This will be to assess: 
• 
 Parents’ opinion of the product 
•       Ease of application 
•       Convenience (cleaning the bed of the powder, etc.) 
•       Parents’ perception regarding improvement seen/not seen 
 
 

4 
Duration of study 
The study will commence on 21st September 2020. 
The duration of this study will be 4 to 6 weeks i.e. each patient will be followed 
up for 4 - 6 weeks for the purpose of obtaining results for this study. However, 
follow up beyond the duration of this study may continue as per patients’ wishes, 
for the purpose of continued therapy of the long -term condition, which may or 
may not involve SWRB. 
Each patient will be followed up every two (2) weeks and the progression or 
regression of the skin lesions recorded. 
 
 
Resources required 
No fee will be paid to any of the investigators. 
Any incidental expenses, i.e. stationary, printing, telephone charges, etc. will be 
borne by the PI. 
 
 
Strengths of this study 
1. Sample size of 50-100 may be achieved within a short duration. 
2. Short duration of study enables the research question to be addressed 
within a short span of time. 
3. The low cost of the SWRB and its abundant availability 
4. SWRB is a waste product converted to human use. Therefore, it has a 
beneficial effect on the environment. 
5. There are few or no studies to show adverse effects of topical use of 
SWRB in humans.  
6. Patients can be obtained from just a few centres. 
7. As studies of this nature using SWRB are rare, this study may encourage 
further research into SWRB and comparative studies. 
8. The SWRB is edible and hence should not cause side effects if small 
amounts are ingested orally. 
9. Study limitations 
1. Lack of sufficient literature or preliminary studies on topical use of SWRB 
for Atopic Dermatitis. 
2. Possibility of patients deciding to withdraw from the study before 
completion. 
3. The application of SWRB as an emollient may be inconvenient in paste 
form. 
 
 
Ethical approval 
This study requires ethical review and approval. Application for the same will be 
submitted to JPEC (Joint Penang Independent Ethics Committee). 
 
 
 
 

5 
Data collection, management and analysis 
Data collection will be done via clinical assessments. Data collection and storage 
will be in accordance with the data protection laws and regulations of Malaysia. 
All data will be stored in a password protected electronic form accessible to and 
managed by the Principal Investigator. Data collected will be analysed using 
sequential analysis. 
 
 
Project management and administration 
The study will be managed by the Principal Investigator, Dato’ Dr Sellappan. 
 
References 
CARROLL, C. L., BALKRISHNAN, R., FELDMAN, S. R., FLEISCHER JR, A. B. & MANUEL, J. C. 2005. 
The burden of atopic dermatitis: impact on the patient, family, and society. Pediatric 
dermatology, 22, 192-199. 
CHAN, Y.-C., TAY, Y.-K., SUGITO, T. L., BOEDIARDJA, S. A., CHAU, D.-D., NGUYEN, K.-V., YEE, 
K.-C., ALIAS, M., HUSSEIN, S. & DIZON, M. V. 2006. A study on the knowledge, 
attitudes and practices of Southeast Asian dermatologists in the management of 
atopic dermatitis. ANNALS-ACADEMY OF MEDICINE SINGAPORE, 35, 794. 
FUJIWAKI, T. & FURUSHO, K. 1992. The effects of rice bran broth bathing in patients with 
atopic dermatitis. Pediatrics International, 34, 505-510. 
GOH, Y.-Y., KESHAVARZI, F. & CHEW, Y. L. 2018. Prevalence of Atopic Dermatitis and Pattern 
of Drug Therapy in Malaysian Children. Dermatitis, 29, 151-161. 
LEE, J. & BIELORY, L. 2010. Complementary and alternative interventions in atopic 
dermatitis. Immunology and Allergy Clinics, 30, 411-424. 
NAGENDRA PRASAD, M., SANJAY, K., SHRAVYA KHATOKAR, M., VISMAYA, M. & NANJUNDA 
SWAMY, S. 2011. Health benefits of rice bran–a review. J Nutr Food Sci, 1, 1-7. 
RUBEL, D., THIRUMOORTHY, T., SOEBARYO, R. W., WENG, S. C., GABRIEL, T. M., 
VILLAFUERTE, L. L., CHU, C. Y., DHAR, S., PARIKH, D. & WONG, L. C. 2013. Consensus 
guidelines for the management of atopic dermatitis: An A sia–P acific perspective. 
The Journal of dermatology, 40, 160-171. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

6 
The SCORAD Index 
Area 
Head and neck 
  (9% BSA)   
0% 
25% 
50% 
75% 
100% 
Upper limbs (left)   (9% BSA)   
0% 
25% 
50% 
75% 
100% 
Upper limbs (right)   (9% BSA)   
0% 
25% 
50% 
75% 
100% 
Lower limbs (left)   (18% BSA)   
0% 
25% 
50% 
75% 
100% 
Lower limbs (right)   (18% BSA)   
0% 
25% 
50% 
75% 
100% 
Anterior trunk 
  (18% BSA)   
0% 
25% 
50% 
75% 
100% 
Back 
  (18% BSA)   
0% 
25% 
50% 
75% 
100% 
Genitals 
  (1% BSA)   
0% 
25% 
50% 
75% 
100% 
Intensity 
A representative area of eczema is selected. In this area, the intensity of each of 
the following signs is assessed as none (0), mild (1), moderate (2) or severe (3). 
Redness 
  
0 
1 
2 
3 
Swelling 
  
0 
1 
2 
3 
Oozing / Crusting 
  
0 
1 
2 
3 
Scratch marks 
  
0 
1 
2 
3 
Skin thickening (lichenification)   
0 
1 
2 
3 
Dryness 
  
0 
1 
2 
3 
Subjective symptoms 
Using a visual analogue scale where 0 is no itch (or no sleeplessness) and 10 is 
the worst imaginable itch (or sleeplessness). 
Itch 
  
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Sleeplessness   
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Source: http://scorad.corti.li/ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

7 
Clinical assessment and tabulation of findings 
 
Area 
 
0% 
25% 
50% 
75% 
100% 
Head and 
neck 
(9% BSA)  
 
 
 
 
Upper limbs 
(left) 
(9% BSA)  
 
 
 
 
Upper limbs 
(right) 
(9% BSA)  
 
 
 
 
Lower 
limbs (left) 
(18% 
BSA) 
 
 
 
 
 
Lower 
limbs 
(right) 
(18% 
BSA) 
 
 
 
 
 
Anterior 
trunk 
(18% 
BSA) 
 
 
 
 
 
Back 
(18% 
BSA) 
 
 
 
 
 
Genitals 
(1% BSA)  
 
 
 
 
 
 
Intensity 
0 
(none) 
1 
(mild) 
2 
(moderate) 
3 
(severe) 
Redness 
 
 
 
 
Swelling 
 
 
 
 
Oozing / 
Crusting 
 
 
 
 
Scratch marks 
 
 
 
 
Skin thickening 
(lichenification) 
 
 
 
 
Dryness 
 
 
 
 
 
Subjective symptoms 
0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or 
sleeplessness). 
Symptom/Score 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Itch 
 
 
 
 
 
 
 
 
 
 
 
Sleeplessness