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

NCT04635072 | Completed Early Phase 1

• 1 other identifier: RC 50
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (3)

• SCORAD index change

  Used to assess the effectiveness of treatment, done before treatment. http://scorad.corti.li/

  0 weeks

• SCORAD index change

  Used to assess the effectiveness of treatment, done during treatment. http://scorad.corti.li/

  2 weeks

• SCORAD index change

  Used to assess the effectiveness of treatment, done after treatment. http://scorad.corti.li/

  4 weeks

Study Arms (1)

Stabilised Whole Rice Bran (SWRB)

EXPERIMENTAL

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.

Drug: Stabilised Whole Rice Bran

Interventions

Stabilised Whole Rice Bran DRUG

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.

Also known as: SWRB

Stabilised Whole Rice Bran (SWRB)

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients below 18 years of age with mild and moderate Atopic Dermatitis

You may not qualify if:

• Those over 18 years of age
• Patients with other forms of dermatitis
• Severe disease
• Those already on other forms of topical therapies, which are likely to interfere with outcomes

Sponsors & Collaborators

• RCSI & UCD Malaysia Campus: lead

Study Sites (1)

Loh Guan Lye Specialist Centre 238, Jalan Macalister 10400 George Town Pulau Pinang

George Town, Pulau Pinang, 10400, Malaysia

Location

Related 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.

  PMID: 15916563 BACKGROUND

• 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.

  PMID: 17160196 BACKGROUND

• 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.

  PMID: 1442022 BACKGROUND

• 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.

  PMID: 29762208 BACKGROUND

• 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.

  PMID: 20670822 BACKGROUND

• 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.

  PMID: 23289827 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Sellappan S

  Loh Guan Lye Specialist Centre 238, Jalan Macalister 10400 George Town, Penang, Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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. The patients will be followed up for four to six 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

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 18, 2020
• Study Start: September 21, 2020
• Primary Completion: April 20, 2021
• Study Completion: September 20, 2021
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: If the results are published in a journal. Time frame not available.
• Access Criteria: Those who subscribe to the publication

Locations

MY (1)