B-WHITE™
MIRROR, MIRROR WHO IS THE FAIREST OF US ALL
SKIN RADIANCE/ SKIN LIGHTENING-
WHITENING/ ANTI-DARK SPOT
Why launching β-White™?
– Innovation
• Huge (and growing) market potential
• First to market!
• Mechanism of action: a breakthrough!
– Performance
• Lucas Meyer Cosmetics knowledge in whitening market
• Full Clinical Efficacy
• Biomimetic peptide
– Safety
• Targeted mechanism of action
• Excellent safety profile
• Batch to batch quality
• Introduction on Brightening Lightening Whitening market
• In Vitro assays – TGF-b receptor binding
– Inhibition of the constitutive production of melanin pathway : TRP1 – TRP2 – tyrosinase
– Inhibition of the tyrosinase activity
– Inhibition of melanin synthesis
– Morphological studies on melanocytes
• Clinical efficacy – Whitening and lightening efficacy
• Tolerance studies
• Applications
• Conclusion
Agenda - Whitening peptide
Why are we using skin whitening?
• Lighten age-spot and hyper-pigmentation
In North America and Europe skin whitening is seen more as a part of anti-aging treatment, to hide unwanted signs of aging like age spot, unhealthy life-style and pollution from the skin
• Whiter / lighter skin tone
– In Asia, lighter and even complexion is associated with higher social status (wealth & education) and a darker complexion has been associated with people who work in the field and are more exposed to the sun.
Vichy®
Market Opportunity?
Global skin lightening market = $13B Driven by new markets in the West and sustained growth in Asia Skin whitening market in Asia!!! 44% of Asian women have problems with brown spots, freckles and pregnancy marks
80% of Asian women report concern over skin darkening
Japan is largest market for skin whitening with 15-17% of all skin care
India & China are the fastest growing segments
Skin whitening market in USA!!! Skin brighteners represent $1.5B in 2008 are also contributing to the growth in anti-aging facial skincare
Why A Growing Trend?
Consumer Info • Who buys B/W/L and why?
- East: Consumers who desire a paler clearer complexion. Non-white Asian and African who want their skin tone to appear as light as possible
- West: Older women whom uneven pigmentation and skin texture caused by years of sun damage and fluctuating hormones are turning for brightening and radiance products.
- Concerns about aging: 1st Dry skin; 2nd Wrinkle; 3rd Age spot Many Different Applications
• Eveness of skin tone
• Anti-aging, Age spots
• Brightening/Whitening/Lightening (BWL)
• Body Care, …
Evolution of whitening products launches
Why A Growing Trend? Market Info
• Important evolution of the BWL products since 2004. High growth!
• Since January 2008: 2150 products were launched with the «BWL claim»
• 2 types of BWL products:
- Cheap, low-end and toxic products (high level of hydroquinone, bleaching agents) → sold legal and illegal market
- High-end skin BWL products develop to modify skin color and achieve youthful-looking skin
• No major innovation regarding the BWL active ingredients for the last couple of years
Skin lightening Market
Multi-usage cosmetic in Prestige & Mass market Skin care (face & body care), men care
Bella Aura Anti-Dark Spot Hand Care Cream
Spain
Superdrug Optimum Night Cream
UK
Oriflame Even Out Face Cream SPF20
UK
Ella Baché Radiance Solution
Australia
Innoxa Even Tone Body Cream
South Africa
Beau Ideal Skin Skin whitening
Taiwan
Market & Regulations
BWL products are driven by consumers desire for flawless complexion and safety concerns
Formulation / Ingredients
• Typical formulations contain mainy BWL active ingredients with complementary mechanism of action (vitamin C derivatives, arbutin, AHA, kojic acid, etc) with SPF
Successfull Whitening products
• Must deliver skin benefits: Paler, Even, Brighter Complexion & Reduce color of hyper-pigmented spot
• MUST HAVE AN EXCELLANT SAFETY PROFILE
Regulatory around the world
• What can be claimed?
- DEPENDS on country specificity & regulation! (ex: Quasi-drug status in Japan)
- «designed to reduce the appearance of dark spots and skin discolouration»
- «restore skin’s luminosity and glow»
- «contains … to slow down excessive melanin production»
Opportunity to develop innovative & safer BWL actives!
Skin Pigmentation
Pigmentation is determined by the amount & type of melanin in the skin
It can be influenced by:
1- Genetic constitutive pigmentation (African, Asian, Caucasian)
2- Facultative pigmentation : UV exposure via α-MSH activation
Skin Pigmentation Actors
Secondary Actors:
• Tyrosinase: Main enzyme involved in pigmentation cascade.
It regulates other enzymes like TRP-1 & TRP-2
• TRP-1 & TRP-2: enzymes involved in pigmentation
Ex: They represents the musicians
Result:
• Melanin pigments: Give the skin its color
Ex: Represent the MUSIC
MITF
Tyrosinase
TRP-1
TRP-2
Main Actor: MITF (microphtalmia-associated transcriptional factor)
• Role in constitutive pigmentation: responsible of phototype
• Role in facultative pigmentation: regulates skin response to UV
Ex: Represents the maestro in the orchestr
It directs the musicians to produce the music
- Facultative pigmentation inhibitor (α-MSH)
- Melanostatine®5
- Tyrosinase inhibitors
- Tyrostat™, Arbutin, Kojic acid, Hydroquinone
- ROS Scavengers
- Ascorbic acid (Tyrostat™ 11), tocopherol
- Signaling pathway between cAMP and tyrosinase
- Tretinoin, Vitamin A
- Inhibitors of melanosomal transfer
- Vit B3, soybean/milk extracts
- Accelerators of skin turnover
- Exo-T™, lactic acid, glycolic acid, AHA
How to Control Pigmentation
β-White™ Our Whitening Solution
Innovative encapsulated peptide!
Whitening peptide TGF-β Agonist
Whitening & brightening
efficacy through a new
pathway via the
inhibition of MITF
Phospholipid capsule (lecithin)
Helps the transport
of the peptide across the skin barrier
β-White™
Encapsulated peptide SAFE & POTENT
β -White™ Targeted Action
Tyrosinase TRP-1
TRP-2
β-White™ Main Action on MITF!!!!
What does it mean?
Can modulate the complete pathways of pigmentation
Can modulate the whole orchestra instead of limiting only few musician
MITF
Tyrosinase TRP-1
TRP-2
Majority of whitening agent act only on Tyrosinase
What does it mean?
Can modulate only one component of the pigmentation process
One musician stops but not the rest of the orchestra = there is still MUSIC
MITF
TGF-b receptor
Binding of β-White™
β-White™ binds specifically to the TGF-β receptor
No free radiolabeled 125I-TGF-b 100% Binding of the radiolabeled 125I-TGF-b
0% binding of β-White™
100% free radiolabeled 125I-TGF-b 0% Binding of the radiolabeled 125I-TGF-b
100% binding of β-White™
125I-TGF-
b β-White™
β-White™ concentration (µg/m) 0 50 100 150 200
80
60
40
20
100
Inh
ibit
ion
of
the
na
tura
l T
GF
-b b
ind
ing
(%
)
120
TFG-β binding capacity
Modulation of the Constitutive Pigmentation Pathway
Test Protocol:
• Melanocytes were incubated with β-White™ at 0.01% for 30 minutes
• Intracellular proteins were extracted
• Proteins are transferred to a membrane and detected using antibodies specific to MITF
and tyrosinase with western blot methodology – MITF (microphthalmia-associated transcription factor): regulation melanin
production – Tyrosinase: key enzyme involved in melanin production
Modulation of the Constitutive Pigmentation Pathway
β-White™ decreases proteins expression implicated in the constitutive pigmentation
β-White™ decreases MITF and tyrosinase expression
Modulation of the Facultative Pigmentation Pathway
Test Protocol:
• Melanocytes were incubated with a-MSH and β-White™ at different concentrations
(0,01 – 0,1 – 1%) for 2 hours
• Intracellular RNA is extracted and quantified by RT-PCR methodology
• Specific antibodies were used to detected TRP-1, TRP-2 and MITF genes expression – TRP-1 & TRP-2 (Tyrosinase related protein): enzymes implicated in melanin
production
Modulation of the Facultative Pigmentation Pathway
β-White™ decreases proteins implicated in the facultative pigmentation
β-White™ decreases MITF, TRP-1 and TRP-2
expression in a dose dependant manner
Inhibition of Tyrosinase Activity
Test Protocol:
• Melanocytes were incubated with a-MSH and β-White™ at different concentrations
(0,01 – 0,1%) for 4 days
• Intracellular proteins were extracted and labelled with L-DOPA • The tyrosinase activity is evaluated by measuring the L-DOPA absorbance at 405 nm
(tyrosinase activity = amount of L-DOPA)
Inhibition of Tyrosinase Activity
β-White™ decreases the tyrosinase activity, thus reducing skin pigmentation
β-White™ decreases tyrosinase activity in a dose
dependant manner
Inhibition of Melanin Synthesis
Test Protocol:
• Melanocytes were incubated with a-MSH and β-White™ at different
concentrations (0,01 – 0,1 – 1%) for 4 days
• Intracellular proteins were extracted • The melanin pigment is detected by measuring the absorbance at 400 nm
(melanin synthesis = amount of brown pigment)
β-White™ decreases tyrosinase and melanin production for optimal whitening efficacy
β-White™ decreases melanin synthesis in a dose dependant manner
Inhibition of Melanin Synthesis
Test Protocol:
• Melanocytes were incubated with a-MSH and β-White™ at different
concentrations (0,01 – 0,1 %) for 4 days
• The morphology of cells were examined by microscopy • The dentricity and the number of melanosomes can be observed
Changes in melanocytes: Dendricity & Melanosome content
Changes of melanocytes: Dendricity & Melanosome content
a-MSH + 0.01% β-White™
Baseline
a-MSH
a-MSH + 0.1% β-White™
Melanosome
β-White™ prevents melanosome formation and thus, reducing the amount of melanin pigments for a lighter complexion
NO Melanosome
40X
Melanin Synthesis Comparative Study
Test Protocol
B16F10 melanocytes were incubated with 10μg/ml (1%) β-White™, 10μg/ml Vitamin C, 10μg/ml Arbutin for 96 hours.
Intracellular proteins were extracted
The melanin pigment is detected by measuring the absorbance at 400 nm
β-White™ decreases melanin synthesis with higher activity than Arbutin and Vitamin C
β-White™ has a higher efficacy than Arbutin &
Vitamin C
In Vitro Activities Summary
Binding to TGF β
Receptor
Decrease of MITF expression
Decrease of tyrosinase
activity
Decrease of TRP-1 & TRP-2
expression
Inhibition of melanin synthesis Reduction of dendricity &
melanosome content
Concentrations used: 0,01- 0,1%
Clinical Efficacy on Skin Whitening / Lightening / Brightening
Protocol:
• 23 Asian subjects presenting at least one hyper-pigmented spot (age 33 to 55) • Application of a Cream with 5% β-White™, twice a day, for 56 days • Colorimetric measurements: analysis of the colorimetric parameter (L*) on the face at D0,
D28 & D56 by spectrophotometer • Clinical evaluation by dermatologist investigators with a skin color scale at D0, D28 & D56 • Questionnaire: closed questions on product efficacy at D0 & D56
Results on Skin Lightness (L*)
β-White™ induces significant skin lightening effect after only 4 weeks
Skin Lightness (L*): is defined as the perceived brightness of an object compared to a perfect white object. The L* value (luminance) gives the relative lightness ranging from total black (L=0) to total white (L=100)
100% of the subjects have a skin lightness increase!
Results on Skin Color
β-White™ induces significant skin lightening effect on pigmented spot after only 4 weeks
D0
D28
D56
Building effect!
-21%
-30%
Results on Skin Color
Additional information on skin color evaluation: - 10 people out of 23 have skin score higher than 5 - 5 people with 5 skin color score:
3 out of 5 have a reduction of 2.5 after 28 days
3 out of 5 have a reduction of 3.5 after 56 days
Average reduction of 2.1 after 28 days
Average reduction of 3 after 56 days
β-White™ induces significant skin lightening effect!!!!
D0
D28
D56
Results on Skin Color
Additional information on skin color evaluation: - 10 people out of 23 have skin score higher than 5 - 5 people with a 5 skin color score:
3 out of 5 have a reduction of 2.5 after 28 days
3 out of 5 have a reduction of 3.5 after 56 days
Average reduction of 2.1 after 28 days
Average reduction of 3 after 56 days
β-White™ induces significant skin lightening effect !!!!
D0 D28
D0 D56
Highest reduction
Results on Skin Color
β-White™ reduces the appearance of pigmented spots
Subject #7 (effect on hyperpigmented spot after 28 days)
Results on Skin Color
β-White™ reduces the appearance of pigmented spots
Subject #16 (effect on hyperpigmented spot after 56 days)
D0
Results on Skin Color
β-White™ lightens the overall skin tone after 56 days
Subject #18 (effect on the overall skin tone)
Results on Consumers Appreciation
Consumers agree that β-White™ makes the skin tone more uniform and brighter
Protocol
19 Caucasian women aged between 51 and 69 years old (mean=58) with pigmentary spots on neckline and hands.
Formulation: Emulsion cream containing 2% b-White™ + 1% Exo-T™
Application: Each product is applied on neckline and hands twice a day (morning & evening) Times measurement : T0, T+14 days, T+28 days, T+56 days Assessment criteria:
- Measurement of skin color (Spectrocolorimeter®)
- Scorage of the spots size and color by the technician
- Subjective evaluation
Clinical efficacy on neckline & hands spots
Scale for the size of spots
1 2 3 4 5 6 7 8 9 10
3 mm 1 cm
Scale for the intensity of spots color
- L* : measurement of the brightness or clarity: ↗ L* parameter = Lightening of the skin
- b*: measurement of blue-to-yellow spectrum: ↘ b* = ↘ in the yellow constituent of the skin
ITA° (individual Typological Angle) defines the skin pigmentation degree and includes L* & b*
When ↗↗ ITA parameter = decrease in skin pigmentation, increase in lightness
The Flawless Duo induces sinificant skin lightening and improves skin tone rapidly!
Consumers appreciation
Tolerance Studies
Excellent Safety Profile
• HET CAM (concentration tested >20%)
• Acute skin tolerance (single patch test) (concentration tested >20 %)
• HRIPT (irritation and sensitization) (concentration tested > 20%)
• AMES Test (concentration tested > 20%)
• No UV-light absorbance (200 – 800 nm) – No risk of phototoxicity
Recommended dosage:
Intensive whitening: 2.5 - 5%
Corrective care & Age-spot: 1 – 2.5%
Lightening care & Skin illumination 0.5 – 1%
1% if combined with an exfoliant
Potential Applications:
INCI name: Water (1) (and) Butylene Glycol (2) (and) Hydrogenated Lecithin (3) (and)
Sodium Oleate (4) (and) Oligopeptide-68 (5) (and) Disodium EDTA (6)
• Whitening care
• Brightening care
• Age-spot treatment
• Anti-aging care
• Specific care: hands, armpits, décolleté
• Skin tone evenness
• Lightening foundation
• Photo-aging
• Ethnic skin care
Applications
Should be incorporated at the end of the manufacturing process, at a temperature of 35/40⁰C at pH6-8
Summary
• β-White™: Innovative and unique whitening agent.
• Effective combination of a TGF-β agonist peptide encapsulated in a liposome.
• Unique regulatory action on the MITF pathway to decrease constitutive and facultative pigmentation!
• Better than Arbutin & Vit C
• Outstanding clinical results: 100% lightening effect
• Excellent safety profile.
Lucas Meyer Cosmetics’ whitening portfolio
Ingredient Origin In vitro Clinical
β-White™ Encapsulated Peptide
(TGF-β biomimetic)
- MITF, TRP 1, TRP2
- Tyrosinase
- Melanin synthesis
- Better efficacy on melanin synthesis than Arbutin & Vitamin C
- Reduction of dendricity & melanosome content
- ↑ Skin lightness by 1.9% after 28 day and +2.9% after 56 days.
- Skin color by 21% after 28 days and -30% after 56 days.
- Consumer test: Consumers found their skin tone more uniform & brigther
Tyrostat™ Plant extract
-Tyrosinase
- Better efficacy on tyrosinase inhibition than Arbutin, Tumeric and Hydroquinone
- Pigmentation (TAN & ERYTHEMA)
- Appearance of age-spots: -15% after 3 weeks & -25% after 6 weeks
-Consumer test with Melanostatine-5 on Asian skin
Melanostatine 5® Peptide
(α-MSH biomimetic)
- Tyrosinase
- Melanin synthesis
-Consumer test with Tyrostat on Asian skin
Exo-T™ Exopolysaccharide
- ↑ Desquamation & differentiation
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