Stabilized Whole Rice Bran (SWRB) for Mild to Moderate Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Early Phase 1

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.
    

Detailed 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.
    

Intervention name(s): Stabilised Whole Rice Bran
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): SWRB
Intervention model: Single Group Assignment
Intervention model description: 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
Masking: None (Open Label)
Primary purpose: Treatment