Comparison of the Efficacy of Lotion Containing Black Rice Bran (Oryza sativa L. indica) Extract with Placebo as Skin Brightening Agent with in Healthy Asian Women
This research is about black rice bran extract which is formulated into lotions which have great
potential as a skin care product to brighten the skin.
Design
Parallel group trial with double blinded application of lotion
Settings and conduct
Each participants are applying lotion A in left elbow and lotion B right elbow twice a day (every morning and evening) for 14 days. Both participants and researchers are blinded
Participants/Inclusion and exclusion criteria
woman, Asian race, age range 18-25 years; healthy skin condition; has no history of
allergies; not pregnant or breastfeeding; has no chronic medical history,, does not have tattoos, scars or burns; not currently using therapies such as anti-inflammatory, corticosteroids, hormonal
contraceptives, or lasers; and do not smoke, do not drink alcohol and do not use drugs, do not
orally consume the test substance (black rice bran extract) and skin brightening agent.
Intervention groups
Lotions containing extract and placebo were applied twice a day in both elbow
Main outcome variables
The skin melanin after application of lotions were measured with mexameter
General information
Reason for update
Acronym
BRBCT
IRCT registration information
IRCT registration number:IRCT20210412050942N1
Registration date:2021-05-01, 1400/02/11
Registration timing:retrospective
Last update:2021-05-01, 1400/02/11
Update count:0
Registration date
2021-05-01, 1400/02/11
Registrant information
Name
Afifah Vardhani
Name of organization / entity
Universitas Indonesia
Country
Indonesia
Phone
+62 622 74372722
Email address
afifah.kusuma@ui.ac.id
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-01, 1398/10/11
Expected recruitment end date
2020-03-23, 1399/01/04
Actual recruitment start date
2020-01-01, 1398/10/11
Actual recruitment end date
2020-02-23, 1398/12/04
Trial completion date
2020-03-12, 1398/12/22
Scientific title
Comparison of the Efficacy of Lotion Containing Black Rice Bran (Oryza sativa L. indica) Extract with Placebo as Skin Brightening Agent with in Healthy Asian Women
Public title
Efficacy of Lotion Containing Black Rice Bran (Oryza sativa L. indica) Extract as Skin Brightening Agent, a Clinical
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
healthy skin condition;
Asian race
Exclusion criteria:
history of allergies;
pregnant or breastfeeding;
chronic medical history,
have tattoos, scars or burns;
currently using therapies such as anti-inflammatory, corticosteroids, hormonal contraceptives, or lasers;
smoke, drink alcohol and use drugs,
orally consume the test substance (black rice bran extract),
apply and consume skin brightening agent topically or orally
Age
From 18 years old to 25 years old
Gender
Female
Phase
1
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
one sample is lotion containing extract, another is placebo lotion
Actual sample size reached:
34
More than 1 sample in each individual
Actual sample size in each individual:
2
one sample is lotion containing extract, another is placebo lotion
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will be given 2 types of lotions to use on right and left elbows, which are applied evenly until they are absorbed. The lotions given have been coded, namely code A-right and code-B-left. This study lasted for 2 weeks (14 days). Every day, participants have to use the lotion for 14 days, twice a day in the morning and evening, each of approximately 1 gram by first washing participants' hands which will be smeared with the lotion and wiped dry. Participants are also asked to rub code A lotion on the back of participants' right hand using the finger of participants' left hand, and apply code B lotion to the back of participants' left hand using the finger of participants' right hand. This is done to prevent lotion A and lotion from mixing. Apply using participants' fingers until all of the lotion is evenly spread and absorbed well. Participants' are prohibited from washing hands at least 1 hour after using the product. Day 14, the use of the lotion is stopped and the researchers will re-check some parameters of
participants' skin's brightness level with a Mexameter tool.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee, Faculty of Medicine, University of Indonesia
Street address
Salemba Raya No 6
City
Jakarta
Postal code
10430
Approval date
2019-12-09, 1398/09/18
Ethics committee reference number
19-10-1170
Health conditions studied
1
Description of health condition studied
Healthy skin condition
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Melanin index
Timepoint
2 weeks after intervention
Method of measurement
Measure skin melanin index with mexameter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: one lotion containing black rice bran extract 10% is applied in one side of volunteer's volar. each application of lotion is 0,5 gram, applied in diameter 5 centimeters. Lotion is applied twice a day (every morning and evening after shower) for 14 days. the excipients of lotions are demineralized aqua, olive oil, vaseline album, dimethicone. Cetyl alcohol, isopropyl myristate, span 80, propylparaben, BHT, tween 80, methylparaben, and glycerin. They are manufactured by Brataco (Indonesia)
Category
Treatment - Other
2
Description
Control group: one placebo lotion were applied in the other side of volunteer's volar. each application of lotion is 0,5 gram, applied in diameter 5 centimeters. Lotion is applied twice a day (every morning and evening after shower) for 14 days. the excipients of lotions are demineralized aqua, olive oil, vaseline album, dimethicone. Cetyl alcohol, isopropyl myristate, span 80, propylparaben, BHT, tween 80, methylparaben, glycerin and colorant. They are manufactured by Brataco (Indonesia)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Pharmacy, University of Indonesia
Full name of responsible person
dr. Afifah Kusuma Vardhani
Street address
Semanggi Hill B5 Jl. Zakaria
City
Depok
Postal code
16426
Phone
+62 622 74372722
Email
afifah.felani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Integrated Laboratory and Research Center, University of Indonesia.
Full name of responsible person
Dede Djuhana, Ph.D
Street address
Lingkar Kampus UI
City
Depok
Postal code
16424
Phone
+62 622 17270152
Email
drpm@ui.ac.id
Web page address
https://research.ui.ac.id/research/
Grant name
QQ Grant
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Integrated Laboratory and Research Center, University of Indonesia.
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of Indonesia
Full name of responsible person
Afifah Kusuma Vardhani
Position
Post graduate
Latest degree
Master
Other areas of specialty/work
Dermatology
Street address
Semanggi Hill B5 Jl. Zakaria
City
Depok
Province
Jawa Barat
Postal code
16426
Phone
+62 622 74372722
Email
afifah.felani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Indonesia
Full name of responsible person
Afifah Kusuma Vardhani
Position
Post graduate
Latest degree
Master
Other areas of specialty/work
Dermatology
Street address
Semanggi Hill B5 Jl. Zakaria
City
Depok
Province
Jawa Barat
Postal code
16426
Phone
+62 622 74372722
Email
afifah.felani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of Indonesia
Full name of responsible person
Afifah Kusuma Vardhani
Position
Post graduate
Latest degree
Master
Other areas of specialty/work
Dermatology
Street address
Semanggi Hill B5 Jl. Zakaria
City
Depok
Province
Jawa Barat
Postal code
16426
Phone
+62 622 74372722
Email
afifah.felani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD