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

NCT04635072 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2023-03-29

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • RCSI & UCD Malaysia Campus

    lead OTHER

Principal Investigators

  • Sellappan S · Loh Guan Lye Specialist Centre 238, Jalan Macalister 10400 George Town, Penang, Malaysia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-21
Primary Completion
2021-04-20
Completion
2021-09-20

Countries

  • Malaysia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04635072 on ClinicalTrials.gov