sun protection products: facts and fiction

8/13/2019 Sun Protection Products: Facts and Fiction

1/56

Sonnenschutzprodukte

Fakten und Fiktion

Uli Osterwalder,

Ciba Inc.,

Basel, Switzerland.


2/56

Conflict of interest

Full time employee of Ciba,Inc., Basel

TINOSORB

M and TINOSORB

SUV filters are manufactured by Ciba


3/56

Sonnenschutzprodukte (Sunscreens)

Fakten und Fiktion

Evolution of Human Skin Photo Types

History of Sunscreens

The Ideal Sunscreen

Four Requirements for Good UV Protection Fictions and Facts

Sunscreens and Skin Cancer

Sunscreens and Melanoma Conclusion


4/56

Evolution of modern human skin photo types(Ke et al, Science 2001)

1492+

1770+

SPF 13

SPF 1

Vit. D3


5/56


Fakten und Fiktion



The Ideal Sunscreen





6/56


Sunscreens were NOTprimarily invented:

to prevent skin cancer

to prevent photo aging

to preserve fair Asian skin.

Sunscreens were invented

to tan without sunburn.


7/56


Sunscreens are very efficient

in preventing sunburn

(Courtesy Ch. Surber/SPIRIG)


8/56

Sun Behaviour in the West

USA 1959 USA 2004


9/56

0

1

290 310 330 350 370 390

/ nm

EA(),SI()

/arbitraryun

its

Erythemal Action Spectrum

Standard Sun Spectrum

Erythemal Effectiveness

UVB UVA

Basics of UV Protection


10/56

Plead for Spectral HomeostasisWe do not yet know the importanceof UVA with regard tophotoaging...and...skin cancer... . Itwould seem prudent, therefore, toencourage the development ofsunscreens which absorb more or

less uniformly throughout the UVspectrum.

Diffey, San Antonio, TX 1991

290 400320

Spectral Homeostasis = Neutral density filter

= Uniform UVB and UVA protection


11/56

Sun avoidance and covering up

Sun Behaviour in the East


12/56

Textiles provide uniform protection


13/56

Textiles provide uniform protection

UV visible

White with optical brightener absorbs more UVA than UVB


14/56

Natrlicher Schutz /

Knstlicher Schutz


15/56


Fakten und Fiktion


History of Sunscreens The Ideal Sunscreen





16/56

The ideal sunscreen

Protects against UVB and UVA

Does reduce the quantity of the UV

radiation

Does not change the quality of the UVradiation that hits the skin

The sun and UV radiationare not the problem;

too much of them is the problemGavin Greenoak


17/56

Evolution of Sunscreens

1. UVB sunscreens ideally

suited for tanning.

2. Better UVA protection

required.

3. Spectral homeostasis as

the ultimate goal.

290 400320 290 400320

290 400320


18/56

CREATING THE VISION OF

THE IDEAL SUNSCREEN

Uniform protection,how can be achieved?

THE LONG WAY BACK TO

UNIFORM UV PROTECTION


19/56


Fakten und Fiktion



Four Requirements for Good UV Protection

Fictions and Facts




20/56

4 Requirements for good UV protection

1. Sunscreen Technology

2. Measurement Method

3. Protection Standard

4. Compliance

UVAI/UV=0.51

Amount, Uniformity ofsunscreen application


21/56

4 Requirements for good UV protection

1. Sunscreen Technology

2. Measurement Method

3. Protection Standard

4. Compliance

UVAI/UV=0.51

Amount, Uniformity ofsunscreen application


22/56

European State of the Art 2005

0

200

400

600

800

1000

1200

290 310 330 350 370 390

Wavelength / nm

E(1,1

)

BEMT

MBBT

DPDT

DHHB

0

200

400

600

800

1000

1200

290 310 330 350 370 390

Wavelength / nm

E(1,1

)

BMDBM

DTS

TDSA

ZnO (Nanox)

ZnO

Situation before Year 2000 New UV-A and

Broad-Spectrum Filters

Since Year 2000


23/56

3 % TiO2, 8 % EHMC, 6 % ZnO, 4 % MBC (T21%) EHT 1.5 %, OCR 2 %, BEMT 2 %, MBBT 4 %, BMBM 3% (T12.5 %)

Sunscreen Spectrum (SPF 30, AUS UVA)calculated on www.ciba.com/sunscreen-simulator

Yesterday (UVA-Balance 12%) Today (UVA-Balance 84%)

Extinction

Extinction

Transmission%

T

ransmissio

n%


24/56

SPF 30 Sunscreen Yesterday and Today

Yesterday (UVA-Balance 12%) Today (UVA-Balance 84%)

Extinction%

Extinction%

290 400320290 400320


25/56

Product Innovation in Europe (UK, 2004)

0.0

0.5

1.0

1.5

2.0

290 310 330 350 370 390

Wavelength / nm

Extinction

Insoluble Filter System

- Zinc oxide

- Titanium dioxide,- Methylene Bis-Benzotriazolyl

Tetramethylbutylphenol

(Bisoctrizole, TINOSORB

M)

Five Stars

Baby Sun Care SPF 50+ ULTRA

0.0

0.5

1.0

290 310 330 350 370 390

Wavelength / nm

TransmissionIn silico

Extinction Transmission


26/56

Safety dossier of a newsunscreen actives (Nohinek, 2001) Acute oral and dermal toxicity

Dermal, ocular irritation, skin sensitization

Photo-irritation, photo-sensitization

Subchronic oral and topical toxicity

Chronic toxicity Fertility, early embryonic development

Embryofetal toxicity and peri-/post-natal toxicity

In vitro and in vivo percutaneous absorption

Topical and oral pharmacokinetic and metabolism

In vitro and in vivo genetic toxicity

Carcinogenicity

Photo-carcinogenicity

EuropeanA

pprova

l29Feb

2000:

Thetox

icologicalt

estresu

ltsindic

ate

noadve

rseeffe

ctsforhuman

use

(SCCNFP

Opinio

n,17Fe

b1999).

USRegistrat

ionspe

cial(ma

jorstudies)

:

Lifetim

edermalc

ancers

tudyon

rats

1year

photo(c

o)carcinogenic

itystud

yonmice

9month

srepea

tedder

maldosingi

nminip

igsExtra

Study:Lack

ofHorm

one

Activity

(Ashbyetal,

2001).

TINOSORB M and TINOSORB S


27/56

Trend towards higher molecular weight

UV absorbers

0

250

500

750

1000

S1 S13 S28 S38 S60 S66 S69 S71 S73 S74 S78 S79 S80 S81 S83

COLIPA order number

Molecularweightin(Da

Figure 13 Trend towards higher molecular weight UV FiltersThe 500 Dalton Rule a common denominator in the development of UV Absorbers

#S1S13S28

S38S60

S69S74S78

UVB/UVA-II FiltersAminobenzoic Acid (PABA)Ethylhexyl SalicylateEthylhexylMethoxycinnamateBenzophenone-34-MethylbenzylideneCamphorEthylhexyltriazonePolysilicone-15Diethylhexyl ButamidoTriazone

#S66S71S73S79

S80

S81

S83

UVA-I/broad-spectrum UV FiltersButyl MethoxydibenzoylmethaneTerephthalylidene Dicamphor Sulfonic AcidDrometrizole TrisiloxaneMethylene Bis-BenzotriazolylTetramethylbutylphenolDisodium Phenyl DibenzimidazoleTetrasulfonateBis-ethylhexyloxyphenol methoxyphenyltriazineDiethylamino Hydroxybenzoyl HexylBenzoate

500 Dalton

> 2000< 2000


28/56

The 500 Dalton Rule a common denominator

500 Dalton rule

for the skin penetration of chemical compounds and drugs:restrict the development of new innovative compounds, to

molecular weight of under 500 Dalton, when topicaldermatological therapy or percutaneous systemic therapy orvaccination is the objective.

Bos JD, Meinardi MM: Exp Dermatol 9(3):165-169 2000

500 Dalton rule for the development of sunscreen actives:

restrict the development of new innovative compounds, to

molecular weight of over 500 Dalton,when sunscreen actives are the objective.

In Analogy:

The 500 Dalton rule does NOT replace the safety assessment!


29/56


Fakten und Fiktion




Fictions and Facts




30/56

Fictions and Facts IFiction

SPF 30 does not offer

double the protection of

an SPF 15

Higher SPF numbers

block only a tiny

percentage more of those

UVB rays.

FACT

Wrong

Erythema is (by

definition) reached when

double the dose of solar

simulated UVR is applied

Not the amount blocked,

but what is passing ontothe skin matters


31/56

Conventional view of sunscreens

Draelos, 2006


32/56

More relevant view of sunscreens

It th UV di ti th t


33/56

Its the UV radiation that

hits the skin that matters

SPF 50 is 5 times better than SPF 10,

not just 8% better as traditional view suggests (98-90%)


34/56

Dynamic view of sunscreens

AS/NZS 2604: 1993


35/56

Fictions and Facts IIFiction

SPF only blocks UVB

rays

FACT

Wrong

Erythema is also

caused by UVAradiation (see action

spectrum)


36/56

Action Spectra of UV Radation


37/56

Fictions and Facts IIIFiction

Mineral UV filters

TiO2 and ZnO are

blockers that reflectonly

FACT

Wrong

Also TiO2 and ZnO

absorb > 90% of theUV radiation because

they are micronized

Large particles wouldreflect (e.g. Wall paint)


38/56

Fictions and Facts IVFiction

Sunscreens do not

protect against skin

cancer (SC)

FACT

Very few clinical

studies

Preventative effect onSSC and AK

Evidence that modern

sunscreens may alsoprevent melanoma


39/56

Fictions and Facts VFiction

Mineral Filters are

natural and safer than

chemical filters

FACT

All registered UV

filters are chemicals

Molecular (soluble)and Particulate

(insoluble) UV Filters

are often combinedsynergistically


40/56


Fakten und Fiktion




Fictions and Facts




41/56

Damage by UV Radiation

CourtesyCh.Surber/SPIRIG


42/56

Action Spectra of UV Radation


43/56

Courtesy

Ch.Surber/SPIRIG


44/56

Prevention of Actinic Keratoses

Ulrich C et al, Charit Berlin

Prevention of UV-induced infectious and malignant skin diseases in organ transplant

patients by regular use of a liposomal sunscreen

L LiverN Kidney

H Heart

efficacy data from

an open,

non-randomized,

case control

study in OTR

treated with avery high

protection class

(UVA+UVB)

liposomal sunscreen

(Tinosorb M,Tinosorb S and

others; Spirig

Pharma Ltd.,

Switzerland).


45/56


Fakten und Fiktion




Fictions and Facts




46/56

Prevention of of BSC and Melanoma?

W l th t ib ti f Ski C


47/56

Wavelengths contribution of Skin Cancer

Lund, Timmins, 2007

W l th t ib ti f


48/56

Wavelengths contribution of

Immunosuppression

Halliday, ASP2008

Sunbeds beauty and melanoma


49/56

Sunbeds, beauty and melanoma

Diffey B, BJD 2007 157, pp215-216

Acceleration only among young women

Introduction

of sunbeds


50/56

Diffey BL, British Journal of Dermatology 2005 153, pp 378-381

Suncreens and Melanoma:


51/56

Suncreens and Melanoma:

The future looks brightDiffey BL, British Journal of Dermatology 2005 153, pp 378-381

Spectrum pre-1990 Spectrum after 2000


52/56

Evolution of Sunscreens1. UVB sunscreens ideally

suited for tanning.2. Better UVA protection

required.

3. Spectral homeostasis asthe ultimate goal.

290 400320 290 400320

290 400320



53/56


Fakten und Fiktion




Fictions and Facts




54/56

Conclusion Sunscreens evolve towards uniform

protection; beyond sunburn protection SPF and UVA measure are required to

assess sunscreens

Besides Technology and Standards,

COMPLIANCE is key.

Modern sunscreens can help preventingskin cancer (due to uniform UVB/UVA

protection)

Current issues with sunscreens


55/56

Current issues with sunscreens

(not discussed) Nanotechnology

Titanium Dioxide and Zinc Oxide

Hormone Activity

Estrogen-like effect of some UV filters

Vitamin D

Fear of overprotection by sunscreen

UVA issue lawsuit against 5 sunscreen manufacturers

Dosis sola facit venenum!


56/56

Dosis sola facit venenum!

(only the dose makes the poison)

Paracelsus, 1493 -1541

City doctor in Basel,

Switzerland 1527-28Town-Hall, Basel (2006)

sun protection products: facts and fiction

Documents