Stabilized Whole Rice Bran (SWRB) for Mild to Moderate Atopic Dermatitis

Dermatitis, Atopic Clinical Trial

— SWRB  

Official 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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04635072
• Other study ID #: RC 50
• Status: Completed
• Phase: Early Phase 1
• Start date: September 21, 2020
• Est. completion date: September 20, 2021

Study information

• Verified date: March 2023
• Source: RCSI & UCD Malaysia Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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. Atopic Dermatitis (AD) is a common condition seen in dermatology, paediatric and primary care clinics in Malaysia. AD poses a significant biopsychosocial burden among sufferers and their families. Current management patterns of AD sufferers in South-east Asia mainly involve use of topical moisturizers and topical corticosteroids.

Rice bran and products derived from it have been studied regarding their anti-oxidant, nutritional, cholesterol lowering and health promoting properties. However, there are very few studies that have focused on the benefits of SWRB when used topically.

SWRB is cost-effective and easily available, while being an under-utilised product. The investigators 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.

The investigators wish to study participants below 18 years of age with mild and moderate Atopic Dermatitis.

The participants will be followed up for four to six (4 - 6) weeks and the clinical features tabulated. This study does not involve any enteral or parenteral administration of SWRB.

Neither does it involve any invasive procedures.

Description:

Objective of the study To study whether the natural product, SWRB, is effective to control the symptoms and signs of mild to moderate Atopic Dermatitis (AD)

Background, rationale & justification.

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 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. Justification: SWRB is cost-effective and easily available, while being an under-utilised product. The investigators 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 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 (RBN). The SWRB is provided Free of Charge for this Study by RBN.

Sample size: The proposed sample size is 50-100 patients of the above mentioned 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.

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.

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

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 participant 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 participants' wishes, for the purpose of continued therapy of the long -term condition, which may or may not involve SWRB. Each participant will be followed up every two (2) weeks and the progression or regression of the skin lesions recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 20, 2021
• Est. primary completion date: April 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

Intervention

Drug:
• Stabilised Whole Rice Bran
Patients with mild Atopic Dermatitis (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, once a day. Patients with moderate disease will use SWRB as a cleanser. In addition, they will also use SWRB as an emollient.

Locations

Country	Name	City	State
Malaysia	Loh Guan Lye Specialist Centre 238, Jalan Macalister 10400 George Town Pulau Pinang	George Town	Penang

Sponsors (1)

Lead Sponsor	Collaborator
RCSI & UCD Malaysia Campus

Country where clinical trial is conducted

Malaysia, 

References & Publications (6)

Carroll CL, Balkrishnan R, Feldman SR, Fleischer AB Jr, Manuel JC. The burden of atopic dermatitis: impact on the patient, family, and society. Pediatr Dermatol. 2005 May-Jun;22(3):192-9. doi: 10.1111/j.1525-1470.2005.22303.x. — View Citation

Chan YC, Tay YK, Sugito TL, Boediardja SA, Chau DD, Nguyen KV, Yee KC, Alias M, Hussein S, Dizon MV, Roa F, Chan YH, Wananukul S, Kullavanijaya P, Singalavanija S, Cheong WK. A study on the knowledge, attitudes and practices of Southeast Asian dermatologists in the management of atopic dermatitis. Ann Acad Med Singap. 2006 Nov;35(11):794-803. — View Citation

Fujiwaki T, Furusho K. The effects of rice bran broth bathing in patients with atopic dermatitis. Acta Paediatr Jpn. 1992 Oct;34(5):505-10. doi: 10.1111/j.1442-200x.1992.tb00997.x. — View Citation

Goh YY, Keshavarzi F, Chew YL. Prevalence of Atopic Dermatitis and Pattern of Drug Therapy in Malaysian Children. Dermatitis. 2018 May/Jun;29(3):151-161. doi: 10.1097/DER.0000000000000376. — View Citation

Lee J, Bielory L. Complementary and alternative interventions in atopic dermatitis. Immunol Allergy Clin North Am. 2010 Aug;30(3):411-24. doi: 10.1016/j.iac.2010.06.006. — View Citation

Rubel D, Thirumoorthy T, Soebaryo RW, Weng SC, Gabriel TM, Villafuerte LL, Chu CY, Dhar S, Parikh D, Wong LC, Lo KK; Asia-Pacific Consensus Group for Atopic Dermatitis. Consensus guidelines for the management of atopic dermatitis: an Asia-Pacific perspective. J Dermatol. 2013 Mar;40(3):160-71. doi: 10.1111/1346-8138.12065. Epub 2013 Jan 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SCORAD index change	Used to assess the effectiveness of treatment, done before treatment. http://scorad.corti.li/	0 weeks
Primary	SCORAD index change	Used to assess the effectiveness of treatment, done during treatment. http://scorad.corti.li/	2 weeks
Primary	SCORAD index change	Used to assess the effectiveness of treatment, done after treatment. http://scorad.corti.li/	4 weeks