Dermatitis, AtopicEarly Phase 1SWRBNCT04635072
Stabilized Whole Rice Bran (SWRB) for Mild to Moderate Atopic Dermatitis
A Early Phase 1 study testing Stabilised Whole Rice Bran in people with Dermatitis, Atopic, run by RCSI & UCD Malaysia Campus at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Stabilised Whole Rice Bran
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteMalaysia
- Study dates
- 21 Sep 2020to 20 Sep 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients below 18 years of age with mild and moderate Atopic Dermatitis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Loh Guan Lye Specialist Centre 238, Jalan Macalister 10400 George Town Pulau Pinang
George Town, Pulau Pinang, 10400
About this study
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?
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.
Read more
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.
Read the 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.
- 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)
- 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).
- 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).
- 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).
- 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.
- 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.
- Conditions
- Dermatitis, Atopic
- Being tested
- Stabilised Whole Rice Bran
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stabilised Whole Rice BranDrug
Also called SWRB
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Stabilised Whole Rice Bran |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCORAD index change
Used to assess the effectiveness of treatment, done before treatment. http://scorad.corti.li/
Measured: 0 weeks
SCORAD index change
Used to assess the effectiveness of treatment, done during treatment. http://scorad.corti.li/
Measured: 2 weeks
SCORAD index change
Used to assess the effectiveness of treatment, done after treatment. http://scorad.corti.li/
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start21 Sep 2020
- Primary completion20 Apr 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- RCSI & UCD Malaysia Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sellappan S, Principal investigator, Loh Guan Lye Specialist Centre 238, Jalan Macalister 10400 George Town, Penang, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635072
- Sponsor's protocol ID
- RC 50
- Acronym
- SWRB
- Status last verified
- Mar 2023
- First submitted
- 4 Nov 2020
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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. The results of the study and protocol may be shared with others if published.
Publications
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.
PubMed 15916563Chan 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.
PubMed 17160196Fujiwaki 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.
PubMed 1442022Goh 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.
PubMed 29762208Lee 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.
PubMed 20670822Rubel 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.
PubMed 23289827
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT04635072
- Acronym / sponsor ID
- SWRB / RC 50
- Conditions
- Dermatitis, Atopic
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- RCSI & UCD Malaysia CampusUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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)
- 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).
- 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).
- 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).
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Stabilised Whole Rice Bran (SWRB) | Experimental | Drug: Stabilised Whole Rice BranPatients 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. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients below 18 years of age with mild and moderate Atopic Dermatitis
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stabilised Whole Rice BranAlso: SWRBPatients 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. | Drug | Stabilised Whole Rice Bran (SWRB) |
Primary outcome
SCORAD index change
Time frame: 0 weeks
Used to assess the effectiveness of treatment, done before treatment. http://scorad.corti.li/
SCORAD index change
Time frame: 2 weeks
Used to assess the effectiveness of treatment, done during treatment. http://scorad.corti.li/
SCORAD index change
Time frame: 4 weeks
Used to assess the effectiveness of treatment, done after treatment. http://scorad.corti.li/
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Background: PubMed 15916563Carroll 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.
- Background: PubMed 17160196Chan 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.
- Background: PubMed 1442022Fujiwaki 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.
- Background: PubMed 29762208Goh 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.
- Background: PubMed 20670822Lee 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.
- Background: PubMed 23289827Rubel 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.
- Individual participant dataSharing planned: Yes. 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. The results of the study and protocol may be shared with others if published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sellappan S principal investigator
Loh Guan Lye Specialist Centre 238, Jalan Macalister 10400 George Town, Penang, Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Stabilised Whole Rice Bran in people with Dermatitis, Atopic, run by RCSI & UCD Malaysia Campus at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCORAD index change (time frame: 0 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04635072, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.