Skin Lightening/Brightening

How to Substantiate Your Cosmetic Claim?

Theresia Sinandang
Head of Skinproof
& Research Coordinator
OUTLINE:

1 INTRODUCTION

2 EFFICACY STUDIES IN HUMAN VOLUNTEERS

a. Regulatory aspect
b. Indonesian skin color: characteristic
c. Study design & procedure
d. Technique of measurement
e. General process: project case

3 CHALLENGES

4 IN CONCLUSION
skinproof.co.id 2
 1 INTRODUCTION

Bright and glowing skin

VS is becoming a more desirable skin
tone, rather than aspiring to having

Whiter or lighter skin

skinproof.co.id 3
 “Indonesian Skin Care Market Segmentation”
All segments within facial care have experienced positive growth

49% 38% 10% 3%

Cleanser & Toner Whitening/ Anti Aging Hydrating/
Lightening Moisturizing

In Indonesia whitening claims declined by 36% in 2018,

while brightening and glowing claims grew by 45% and 242% respectively.

Source: “What’s trending in Indonesian Skin Care”,Mintel Report, June 2019

skinproof.co.id 4
 Those claims should
be supported by
adequate and
verifiable evidence

Image source:https://www.neutrogena.com skinproof.co.id 5

Type of Evidence

1
Applying the use of published information (scientific Literature Review/
publication, scientific state of the art, and market data Research

2
Such tests evaluate consumers’ perception of product Consumer
efficacy and cosmetic properties based
on parameters that they can observe or feel.
Perception Test

Experimental studies include (but are not limited

3 to) studies in silico, in vitro, ex-vivo, with

instrumental or biochemical methods, studies
conducted on volunteers, investigator evaluations,
Experimental
Studies
sensory evaluations, etc.

skinproof.co.id 6
2 EFFICACY STUDIES IN HUMAN VOLUNTEERS

Skin Lightening
Claim Substantation

skinproof.co.id 7
Regulatory aspect

BPOM, Asean Directive, Cosmetic Europe, etc

Cosmetic Guideline Cosmetic claim labbeling, safety & efficacy evaluation.....

BPOM, World Medical Association (WMA)

Ethical Aspect Cara Uji Klinik Yang Baik/ Good Clinical Practice,
Declaration of Helsinki

ISO, ASTM, EEMCO, published scientific jounal, in house SOP

Claim Substantiated - ASTM, “Standard guide for sensory claim substantation
- EEMCO, “Guidance for the assessment of skin colour”

skinproof.co.id 8
 Thomas Fitzpatrick, MD, PhD
“Fitzpatrick develop classification scale of
skin color by complexion, and their
tolerance of sunlight”

Skin Color Skin Characteristics

I White, very fair, always burn, never tans

II White, fair, ussually burn, tans with difficulty

III Thomas
Cream white, Fitzpatrick,
sometimes mild burn, MD, PhD
gradually
tans
IV Brown, rarely burn, tans with ease

V Dark brown, very rarely burn, tans very easily

VI Black, never burns, tans very easily

skinproof.co.id 9
Indonesian Skin Color Skin becomes darker and more yellow
with age, and appear pigmented
General characteristic lesions such as ephelids, melasma,
lentigo, due to sun exposure

skinproof.co.id 10
 Study Design & Procedure
Depends on your products
strategy (targeted claim, and
objective the study) and
budget

Comparator or non Test Sites

comparator study? No of subjects
Face, body area, volar arm,
armpit

Product
Standard Product
Applications Washout Period
Single, repeated, how long? Complement

skinproof.co.id 11
Technique of measurement
Investigator Evaluations

Performed by trained assesor, using digital images with

standard lighting and position
Global Aesthetic Investigator Scale

Score Grade Description

3 Very much improved Very marked improvement in appearance

2 Much improved Marked improvement in appearance
1 Improved Improvement in appearance
0 No Change Essentialy the same as original condition
-1 Worse Worse than the original condition
-2 Much worse Much worse than the original condition
-3 Very much worse Very much worse than the original condition
skinproof.co.id 12
Visit 1: Baseline Visit 2: T+2 week
T+2W Visit 2:T+4W
T+2 week
Baseline IGA Score:
Score =?? IGAScore
Score= :??

skinproof.co.id 13
Technique of measurement
Instrumental method : Melanin & Erythema index

Principle method
Narrow band reflectance spectrophotometry
Instrument: by Mexameter®, Dermaspectrometer®

Each index increases as the skin

become more erythematous or
more pigmented, respectively

skinproof.co.id 14
Technique of measurement
Instrumental method : Melanin & Erythema index

Study objective: in comparison whitening efficacy GSSG (test product) with placebo

Conclusion:
Test product (GSSG) have
properties for skin
brightening by lowering
melanin index value
compares to baseline.

*Published jurnal source: Clin Cosmet Investig Dermatol. 2014 Oct 17;7:267-74. doi: 10.2147/CCID.S68424
skinproof.co.id 15
skinproof.co.id 16
Technique of measurement
Instrumental method: Reflectance tristimulus CIE colorimetry

Quantifiying color by Commission on Illumination

(CIE) with L*a*b

L* = Lightness (also refered as Luminance) , the

lightness or darkness of a color
a* = Red (+a) to Green (-a)
b* = Yellow(+b) to Blue (-b)

L* and b* values correlate linear with the amount

of epidermal melanin, use as parameter to evaluate
skin pigmentation
a* correlate linear with the amount of Hb, use as
parameter for evaluating the degree of
erythema

skinproof.co.id 16
Technique of measurement
Instrumental method: Reflectance tristimulus CIE colorimetry

Individual Typology Angle (ITA) calculated from

value L* and b*

ITA = [tan-1((L*50)/b*)]180/3,14

ITA value correlate with skin tone category, the

higher of ITA value, the skin more lighter

Available Instrument: Skincolorcatch®,

Chromameter®, Skin Colorimeter®

skinproof.co.id 17
Technique of measurement
Instrumental method: Reflectance tristimulus CIE colorimetry

Study objective: Whitening efficacy evaluation of Cosmetic Active Ingredient

*Published product information: Corum 9515

skinproof.co.id 18
Technique of measurement
Self Assesment Using Questionnaire

Subject will be asked to judge the

product efficacy using their self
perceptions
Attribute questions : hedonic/liking,
intensity, or product preference

The evaluation possible to perform at

home to represent actual judgment in
natural enviroment

skinproof.co.id 19
 Technique of measurement
Self Assesment Using Questionnaire

# Pada akhir penelitian dan setelah memakai produk, saya dapat melihat tampilan kulit
wajah saya menjadi lebih cerah.
1. Sangat tidak setuju 2. Tidak setuju 3. Kurang setuju 4. Netral 5. Agak setuju 6. Setuju 7. Sangat setuju

# Pada akhir penelitian dan setelah memakai produk, bagaimana anda menilai tampilan kulit
wajah Anda?
1. Menjadi kusam 2. Menjadi 3. Agak 4. Tidak ada 5. Agak lebih 6. Lebih cerah 7. Sangat cerah
sekali Lebih kusam kusam perubahan cerah

# Apakah Anda menyukai produk ini untuk dapat membantu mencerahkan kulit wajah?
1. Sangat tidak suka 2. Kurang suka 3. Netral 4. Suka 5. Sangat suka

skinproof.co.id 20
General Process :Project Case
Product Name: Multi Function Sunscreen
Listed of Claims

1.“Instantly feels bright after application”

2.“Skin feels smooth immediately after
application”
3.“Clinically proven for brighter skin in 2 weeks”
4.Wrinkle improvement
5.Sun protector : SPF 50+, PA+++
6.Dermatology tested and hypoallergenic
formulation

skinproof.co.id 21
General Process :Project Case
Protocol Study

Design study Non comparator study, full face , non Added In vivo SPF and PA test in 10
randomized study 1 subject
Subject 28 female, age 18-25 (4 weeks) Method: Sunscreen evaluation
ISO 24444 & ISO 24442
Outcome 1. Sensory evaluation bright, smooth with
parameter & self assessment questionnaire.
methodology 2. L*, ITA values evaluation with Added Skin irritation & sensitization
Skincolorcatch® study 2 study in 50 subject
3. Skin texture (wrinkle, smoothness, (10 weeks) Method: Human Repeated
roughness) evaluation with Visioscan Insult Patch Test
Clinical [4] : Baseline, T+2 week, T+4 week , T+8 week
evaluation

skinproof.co.id 22
 General Process :Project Case
Conduct the Study

Sponsor Approval

Clinical Data evaluation

Ethical Approval evaluation Statistical analysis
Subject recruitment (baseline) reporting

Protocol Informed consent Clinical

development Washout period evaluation
(T+8 weeks)
Final Report
Timeline (week)

W0 W2 W7 W9 W18 W20
skinproof.co.id 23
 CHALLENGES
Challenges 3

Claim
Regulation, study result

Subject Compliance :
Product sensory, long study duration, product regimen

Budget:
Type of evidence/ study, no of subject, study duration, claims

Timeline:
Approval process, subject recruitment, subject drop out/withdrawal, products

skinproof.co.id 24
 4 IN CONCLUSION

Conduct efficacy evaluation in human volunteers

FIRST STEP
SECOND STEP
Desired Claim
THIRD STEP
Targeted claim spesified Written study
by product, where claim protocol
will be placed (ads), Conduct the LAST STEP
Population, study
competitor if any,
design, outcome
study
budget, regulation 1. Subject recruitment
Final report
parameter (method),
document approval, 2. Washout, procedure Report content, data
informed consent, case 3. Data collecting evaluation, statistical
report form 4. Study monitoring evaluation, data archive

skinproof.co.id 25
Contact Us

Research Centre
Jl. Arjuna Utara No 52, Duri Kepa
Kebon Jeruk, Jakarta Barat
DKI Jakarta - 11510

Call center:
+62856-1950-5252

www.skinproof.co.id

Theresia Sinandang
Theresia.sinandang@skinproof.co.id
+62856-9299-4211

26