ORIGINAL RESEARCH
Ou doo es ing o he pho op o ec ion p o ided
by a new wa e -based b oad-spec um SPF50+
sunsc een p oduc : wo double-blind, spli - ace,
andomized con olled s udies in heal hy adul s
This a icle was published in he ollowing Do e P ess jou nal:
Clinical, Cosme ic and In es iga ional De ma ology
Co inne G ange
1
Yolanda Sola
2
Yolanda Gilabe e
3–6
Ca les T ullàs
1
1
Inno a ion and De elopmen , ISDIN,
Ba celona, Spain;
2
Me eo ology G oup,
Depa men o Applied Physics,
Uni e si y o Ba celona, 08028 Ba celona,
Spain;
3
De ma ology Depa men ,
Hospi al Uni e si a io Miguel Se e ,
Za agoza, Spain;
4
Academia Española de
De ma ología y Vene eología, Za agoza,
Spain;
5
Re is a Ac as De mo-Sifiliog
áficas, Za agoza, Spain;
6
Heal h Sciences,
Uni e si y o Za agoza, Za agoza, Spain
Pu pose: Use s o en unde -apply sunsc eens, and one o he main easons ci ed o his is
he cosme ic o mula ion o he p oduc . To add ess his, we de eloped a wa e -based
sunsc een. The p oduc unde wen s anda d labo a o y es ing (ISO 24444: 2010) and was
de e mined as sun p o ec ion ac o (SPF) 50+. Howe e , such labo a o y es ing does no
ake in o accoun en i onmen al ac o s o in-use condi ions ha could po en ially a ec
sunsc een e ficacy, pa icula ly o new cosme ic o mula ions. We aimed o es his p oduc
in condi ions mo e ep esen a i e o eal-li e sola exposu e, o confi m i s epo ed labo a-
o y e ficacy.
Me hods: Two double-blind, andomized, con olled, spli - ace in a-indi idual s udies we e
conduc ed du ing summe mon hs in Ba celona. One s udy compa ed he p oduc agains an
SPF15 con ol ( e e ence s anda d P3 o ISO 24444: 2010), while he o he compa ed agains
an SPF50+ con ol (ano he comme cially a ailable sunsc een). A echnician applied he
p oduc s be o e sun exposu e: in es iga ional p oduc (IP) o one hal o he ace and he
espec i e con ol p oduc o he o he . Subjec s spen 4–6 h s ou doo s pe o ming quie
ac i i ies, and sunsc eens we e eapplied a 2 hou ly in e als. A de ma ologis clinically
sco ed acial e y hema a baseline and a 24 h s.
Resul s: Six y-fi e subjec s we e included in o al. In bo h s udies, skin ea ed wi h he IP showed
no significan inc ease in clinical e y hema sco ing a 24 h s. The e we e s a is ically significan
di e ences be ween he IP and he SPF15, bu no be ween he IP and he SPF50+ con ol. SPF15
did no p o ec all subjec s agains sola -induced e y hema.
Conclusion: These ou doo s udies confi m he e ficacy o his new SPF50+ wa e -based
sunsc een in condi ions ha close ep esen eal-li e sun exposu e.
Keywo ds: e y hema, sunbu n, sunsc een, pho op o ec ion, eal-li e es ing
In oduc ion
Sola adia ion induces acu e and ch onic damage o he skin and is po en ially
ca cinogenic.
1,2
Despi e e o s o inc ease awa eness,
3
sunbu n p e alence emains
high. A 2012 epo by he Cen e o Disease Con ol and P e en ion ound ha
50% o adul s and 66% o whi e adul s aged 18–29 in he USA epo ed a leas one
sunbu n in he p e ious 12 mon hs.
4
Ul a iole (UV) B induces sunbu n, and DNA
may be damaged di ec ly ia UVB-induced gene a ion o cyclobu ane py imidine
dime s and hymine dime s, o indi ec ly ia UVA-induced gene a ion o eac i e
Co espondence: Co inne G ange
ISDIN, P o ençals 33, Ba celona 08019,
Spain
Tel +34 932 402 020
Fax +34 932 020 980
Email co inne[email p o ec ed]
Clinical, Cosme ic and In es iga ional De ma ology Do ep ess
open access o scien ific and medical esea ch
Open Access Full Tex A icle
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oxygen species.
2
Epidemiological e idence shows an asso-
cia ion be ween cumula i e sun exposu e and non-
melanoma skin cance s,
2
and be ween episodic se e e
sunbu n and melanoma.
5,6
Pho op o ec ion is he e o e ecommended o
minimize skin damage.
7
Key app oaches a e seeking
shade, wea ing p o ec i e clo hing, and using sunsc een
on exposed a eas. Sunsc eens a e o en he main mode o
p o ec ion used in ou doo ac i i ies,
4,8
ye despi e his
eliance, many use s con inue o unde -apply sunsc eens
a quan i ies below he ecommended 2 mg/cm
2
.
9,10
A eluc ance o apply abundan sunsc een has been a ib-
u ed o cosme ic aspec s, such as oiliness, s ickiness, o
unpleasan ex u e.
11,12
To add ess his, we de eloped
a wa e -based b oad-spec um sunsc een p oduc (ISDIN
Fusion Wa e ) o mula ed o abso b quickly and a oid
esidues, ha would be pleasan o use while s ill p o id-
ing e y high UV p o ec ion.
This new p oduc was es ed using he in e na ional
s anda d labo a o y me hod (ISO 24444: 2010)
13
and
de e mined o ha e a sun p o ec ion ac o (SPF) o 50+.
SPF is he well-es ablished me ic o sunsc een p o ec ion
agains sunbu n, de e mined on in i o labo a o y es ing.
Al hough SPF has become he accep ed wo ldwide s an-
da d o measu ing sunsc een e ficacy, he e emain some
con o e sies ega ding he me hod and he e ec s o eal
condi ions o use on he p o ec ion achie ed in ou doo
condi ions.
14,15
SPF es ing aims o induce e y hema as
apidly as possible
13,16
using sola simula o s ha emi UV
adia ion in he egion o 290–400 nm, while added fil e s
cu o adia ion below 290 nm and beyond UV wa e-
leng hs; consequen ly, he e ec s o in a ed o isible
adia ion on skin a e no aken in o accoun .
2,17
Fu he mo e, in eal-li e condi ions, he quali ies o he
p oduc once applied o he skin may be influenced by he
en i onmen (eg, empe a u e).
18,19
Unlike mo e well-
s udied, classical oil-based p oduc s, he e was no e i-
dence on how his newly de eloped wa e -based p oduc
would beha e in eal li e. Ou aim was o assess he
e ficacy o his p oduc in condi ions ha would close
ep esen eal-li e sola exposu e, o p o ide a mo e obus
le el o e idence on i s e ficacy ou side he labo a o y,
while s ill ensu ing adequa e applica ion. Ou hypo hesis
was ha he in es iga ional p oduc (IP) would p o ide
be e p o ec ion han he SPF15 and compa able p o ec-
ion o he SPF50+ con ol, bu we wan ed o es ablish his
in a non-labo a o y se ing, in case he new p oduc
beha ed unp edic ably in eal-li e condi ions.
Ma e ials and me hods
S udy design
Two double-blind, spli - ace, andomized con olled s u-
dies we e designed o assess he clinical e ficacy in p e-
en ing e y hema o a new wa e -based b oad-spec um
SPF50+ sunsc een p oduc using es ablished sunsc een
p oduc s as con ols. The s udies we e designed in pa allel,
bu conduc ed in di e en mon hs o logis ical easons,
om July o Sep embe 2018, in Ba celona, Spain. They
we e designed as independen s udies bu used a simila
me hodology.
IP and con ols
The IP was a combina ion o lipophilic o ganic sun fil e s:
e hylhexyl me hoxycinnama e, bu yl me hoxydibenzoyl-
me hane, e hyl hexyl iazone, and a physical fil e : i anium
dioxide, o mula ed in a wa e -based inno a i e galenic o -
mula ion. The IP was compa ed in he wo sepa a e s udies
agains anSPF15sunsc een( e e ences anda dP3o ISO
24444: 2010,
13
con aining he sola fil e s e hylhexyl me hox-
ycinnama e, bu yl me hoxydibenzoylme hane and phenylben-
zimidazole sul onic acid) and a di e en SPF50+ sunsc een
om he same manu ac u e (sola fil e s: oc oc ylene, bu yl
me hoxydibenzoylme hane, bis-e hylhexyloxyphenol me hox-
yphenyl iazine and i anium dioxide). The SPF50+ con ol
was chosen in he absence o a e e ence s anda d o SPF50+
assessmen .
Subjec s
The inclusion c i e ia o he wo s udies we e gene ally
equi alen : heal hy male and emale adul s aged 18–60
yea s old (18–55 in s udy 2), o all skin ypes, wi h
Fi zpa ick pho o ype I–IV (I–III in s udy 2), ITA (indi i-
dual ypology angle) o e 28 on he back, who we e a
leas occasional use s o cosme ic p oduc s o sun ca e
p oduc s. The s udies excluded hose wi h skin ma ks
ha could in e e e wi h assessmen (pigmen a ion diso -
de s, sca ing, la ge numbe o ne i, e c.), his o y o alle -
gic eac ions o simila p oduc s, his o y o skin cance o
dysplas ic ne i, ac i e acial skin disease, endoc ine dis-
ease, immunosupp essi e condi ions o medica ions, and
any ea men s ( opical o o al, including ood supple-
men s) ha may a ec skin pigmen a ion o eac ions.
P egnan o b eas eeding women we e no allowed.
Twen y-nine subjec s we e ini ially included in s udy 1
( s SPF15), and 38 in s udy 2 ( s SPF50+). S udy 1
compa ed agains SPF15 and was conduc ed in
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Sep embe , and s udy 2 compa ed agains SPF50+ and was
conduc ed in July. As s a ed abo e, he wo s udies we e
designed in pa allel, as independen s udies in ol ing
simila me hodology, and due o logis ical easons only
we e conduc ed in his o de .
Bo h s udies we e pe o med on sunny days wi h clea
skies o low cloud co e ; i he e was cloudy wea he on
he planned s udy day, he s udies we e pos poned. Bo h
we e spli - ace design, wi h he IP applied o one hemi ace
and SPF15 o SPF50+ con ol o he o he . The side o he
ace o be ea ed wi h each p oduc was alloca ed acco d-
ing o a andomiza ion able. The s udy echnician applied
2 mg/cm
2
o each p oduc using a finge s all 30 mins
be o e exposu e. In he fi s 4–5 subjec s, a Wood lamp
was used o assess e en co e age wi h he sunsc een
p oduc s a e he fi s applica ion.
S udy 1 ( s SPF15) las ed 6 h s (app oxima ely 10.30
am–12.30 pm and 1.30 pm–5.30 pm, wi h a 30-min b eak
be ween) and was conduc ed on he sun e ace o a fi ness
cen e . Subjec s pe o med ee quie ac i i ies (no wa e -
ela ed o excessi e swea -inducing ac i i ies we e planned).
Subjec s we e ins uc ed o eques eapplica ion o sunsc-
een p oduc s as hey el necessa y, and he echnician hen
applied hem on hei eques , a e he fi s 2 h s.
S udy 2 ( s SPF50+) was conduc ed in a public squa e
o e 4 h s. A subg oup o ou subjec s began he s udy and
conduc ed p esc ibed ac i i ies a 30-min in e als: walking,
si ing( eading/lis ening omusic),andlying aceupwa d.
They spen 2 h s ou doo s (10 am–12 noon) hen sunsc een
was eapplied du ing a 30-min indoo b eak, be o e a u he 2
h s’exposu e (12.30–2 pm). Howe e , he in es iga o judged
ha he pe iod o exposu e was oo long du ing c i ical hou s,
so he p o ocol was modified o he emaining 25 subjec s, o
s a and finish ea lie in he day (9 am–1pm)wi h5-
min shade b eaks upon eques , and eapplica ion o sunsc een
p oduc s upon subjec s’ eques any ime a e he fi s 2 h s.
Subjec s we e also allowed o pe o m he pe mi ed ac i i ies
eely p o ided hey espec ed he s udy cons ain s.
E y hemal UVB adia ion
Cumula i e doses o e y hemal UVB adia ion we e
de e mined om e y hemal i adiances measu ed
wi h a b oadband YES UVB-1 py anome e (Yankee
En i onmen al Sys ems, MA, USA) ins alled on he oo o
he acul y o physics o he Uni e si y o Ba celona. The
ins umen belongs o he Radiome ic Ne wo k o he
Spanish Me eo ological Se ice (AEMET). The py anome e
has a spec al esponse close o he e y hema ac ion spec um
20
and measu es he sola adia ion ecei ed by a ho izon al su -
ace om he whole sky. The UV index,
21
a ool de eloped o
in o m he public o he po en ial e y hemal e ec o sola
adia ion, was de e mined om hese measu emen s. Bech
e al
22
p e iously epo ed on he clima ology and UV index
in his loca ion.
Endpoin s
The objec i e o he s udy was o assess he e ficacy o he IP
in p e en ing e y hema in a se ing mo e ep esen a i e o eal-
li e sola exposu e. The p ima y endpoin o bo h s udies was
he e y hema sco e ollowing ou doo sun exposu e, based on
clinical examina ion o acial e y hema a baseline and a 20±4
h s pos exposu e. In s udy 1 ( s SPF15) a scale o 0–9was
used, wi h 0 being no e y hema and 9 being e y in ense
e y hema,
23
whiles udy2usedascaleo 0–4
24,25
(Table 1).
Subjec s we e also ques ioned and examined by
a de ma ologis o esponsible echnician ega ding local
skin eac ions a hese same ime poin s and gi en an indi i-
dual obse a ion shee o eco d any symp oms. The de ma-
ologis s and echnicians who assessed e y hema, as well as
he subjec s, we e blinded o he ea men alloca ions.
As a seconda y objec i e, we we e in e es ed o see i he
s udy design would disc imina e be ween he pho op o ec-
i e abili y o ou wa e -based IP and he con ol sunsc eens.
S a is ical analysis
Means and SD we e calcula ed o clinical sco ing.
Wilcoxon signed ank es was used o compa e he
Table 1 Clinical e y hema scale
S udy 1 S udy 2
Sco e Desc ip ion Sco e Desc ip ion
0 No e y hema 0 No e y hema
1 Ve y sligh e y hema (ba ely pe cep ible) 1-2-3 Ve y sligh e y hema
2 Sligh e y hema (well defined) 4-5 Sligh e y hema
3 Mode a e e y hema 6-7 Mode a e e y hema
4 S ong e y hema 8-9 Ma ked e y hema
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di e ences be ween he sco e a baseline and 20±4 h s,
be ween he IP and he espec i e con ol p oduc . The
esul s o he wo s udies we e independen and no com-
pa ed wi h each o he . SPSS . 6.1.3. (s udy 1) and .3.4.3
(s udy 2) we e used o pe o m he s a is ical analysis;
P<0.05 was conside ed s a is ically significan .
E hical conside a ion
All subjec s p o ided signed in o med consen . The s udies
we e pe o med aking in o accoun he p inciples o Good
Clinical P ac ice (E6: CPMP/ICH/135/95) and he
Decla a ion o Helsinki 1964 and i s subsequen amend-
men s. Due o he na u e o he IP being cosme ic a he
han medicinal, e hics commi ee app o al was no equi ed.
Resul s
The de ails o he s udy subjec s a e p esen ed in Table 2.
The dis ibu ion by pho o ype was, o s udy 1: 0%
Fi zpa ick ype I, 32% ype II, 66% ype III, 3% ype
IV; o s udy 2: 7% ype I, 41% ype II, 52% ype III.
UV doses
In s udy 1, he maximum UV index was 5.9, and he mean
(±SD) o al cumula i e dose (6 h s) o e y hemal UVB
adia ion was 200.3±14.8 mJ/cm
2
. Sunsc eens (IP and con-
ol) we e applied a mean 3.2 imes (min 2–max 5) du ing
he 6-h sola exposu e pe iod. In s udy 2, he maximum UV
index du ing s udy hou s was 8.5, and he mean o al
cumula i e dose (4 h s) o e y hemal UVB adia ion was
164.9±15.8 mJ/cm
2
. Sunsc eens we e applied a mean 1.7
imes (min 1–max 2) du ing he 4-h exposu e pe iod.
E y hema
In bo h s udies, in skin ea ed wi h he IP, he e was no
s a is ically significan di e ence in e y hema sco e om
baseline o 20±4 h s a e exposu e (Tables 3 and 4).
In s udy 1, he e y hema sco e a 20±4 h s was no sig-
nifican ly di e en om baseline o he IP (mean e y hema
sco e inc ease o 6%, P=0.66) bu was significan ly highe o
he SPF15 p oduc (mean e y hema sco e inc ease o 16%,
P<0.01). Only 3 subjec s had an inc ease in he e y hema
sco e (o 1 poin ) o he a ea co e ed wi h he IP, s 9 subjec s
o he a ea co e ed wi h he SPF15 (8 wi h an inc ease o 1
poin and 1 wi h an inc ease o 2 poin s) (Table 5).
In s udy 2, he e was no s a is ically significan di e -
ence in e y hema sco e a 20±4 h s be ween he IP and he
con ol SPF50+ (P=0.45).
A pos -hoc analysis (Wilcoxon es ) by Fi zpa ick skin
ype subg oups ( ype II s ype III in s udy 1 and ype I+II
s ype III in s udy 2) e ealed no s a is ically significan
di e ences be ween g oups o changes a 24 h s.
Tole abili y
In s udy 1, no skin o eye eac ions we e epo ed. In s udy
2 ( s SPF50+), no skin eac ions occu ed. Two subjec s
epo ed ocula i ching wi h bo h he IP and he con ol
sunsc een (bila e al i ch), and 2 subjec s had i ching wi h
he con ol sunsc een bu no he IP (unila e al).
Discussion
These wo s udies show ha , wi h he ecommended appli-
ca ion quan i y (2 mg/cm
2
), ollowing 4–6 h s o ou doo
sun exposu e in a Medi e anean loca ion in summe , he
in es iga ional wa e -based SPF50+ sunsc een p oduc
p e en ed sola e y hema –indica i e o inflamma ion –
in indi iduals wi h Fi zpa ick pho o ypes I–IV, which is o
clinical in e es ega ding long- e m skin heal h. The IP
was supe io o SPF15 and had a compa able le el o
pho op o ec ion o an exis ing SPF50+, confi ming he
p oduc p o ided a e y high le el o sun p o ec ion.
I was somewha su p ising o obse e ha in he
SPF15 con ol g oup, he e was a s a is ically significan
inc ease in e y hema (+16%), which could sugges ha
SPF15 is insu ficien unde such ci cums ances o summe
wea he and in subjec s wi h a majo i y (66%) Fi zpa ick
pho o ype III. Assessing he minimum SPF equi ed o
Table 2 S udy subjec cha ac e is ics
S udy 1 S udy 2
No. pa icipan s 38 29
Wi hd ew
a
01
Excluded
b
01
Included in analysis 38 27
Age, mean (min–max) 43 (21–59) 39 (18–55)
Sex
Female 30 (79%) 17 (63%)
Male 8 (21%) 10 (37%)
Fi zpa ick pho o ype
I 0 (0%) 2 (7%)
II 12 (32%) 11 (41%)
III 25 (66%) 14 (52%)
IV 1 (3%) NA
No es:
a
Subjec wi hd ew o pe sonal easons un ela ed o s udy.
b
Subjec
excluded o p o ocol noncompliance.
Abb e ia ion: NA, no applicable (subjec s wi h skin pho o ype IV we e no
included in his s udy).
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p e en e y hema was no he p ima y endpoin o his
s udy, bu i is in e es ing o eflec on his finding wi hin
he con ex o he ecommenda ions om es ablished asso-
cia ions: while some ecommend a minimum SPF o 15,
,26
o he s sugges SPF30.
27,28
Indeed, de ma ologis s may
simply ecommend “ he highes possible p o ec ion” o
hei pa ien s.
7
Ou findings poin owa d he la e op ions
being mo e app op ia e, al hough es ablishing such
a ecommenda ion was no ou objec i e. None heless,
any educ ion in e y hema is iewed as beneficial due o
i s associa ion wi h inflamma o y p ocesses.
The uniqueness o his s udy lies in i s design. Being an
ou doo s udy, i allowed us o include he ull spec um o
sola adia ion, including isible and in a ed ligh .
2
In
addi ion, he spli - ace design minimized a iabili y and
allowed us o posi ion he p oduc wi h e e ence o exis -
ing sun p o ec ion p oduc s, while main aining scien ific
s anda ds ha ensu ed a ai compa ison o he es ed
p oduc s, and ensu ing applica ion in line wi h ecom-
mended me hods o use. Al hough s udy 2 ( s SPF50+)
was ca ied ou in July when he UV adia ion is highe
han ha in Sep embe , sho e exposu e pe iods ou side o
sola noon esul ed in smalle doses.
While mos s udies es ing sunsc een e ficacy a e con-
duc ed indoo s, he e a e e y ew s udies compa ing sunsc-
eens in eal-li e condi ions o sola adia ion exposu e.
A ecen s udy by Williams e al
24
assessed in 199 heal hy
men and women in a single-cen e andomized con olled
spli - ace double-blind s udy he sunbu n p o ec ion p o ided
by an SPF100+ s SPF50+ sunsc een in ac ual use condi ions.
They concluded ha he SPF 100+ sunsc een was significan ly
mo e e ec i e in p o ec ing agains sunbu n han SPF 50+.
24
Those esul s suppo he idea ha highe SPFs may p o ide
meaning ully imp o ed pho op o ec ion in eal condi ions o
use by compensa ing o use s’unde -applica ion (in he s udy,
subjec s applied a ound 1 mg/cm
2
, in con as o he
Table 5 Inc eases in e y hema sco es a 24 h s
S udy P oduc No inc ease Inc ease by 1 poin Inc ease by ≥2 poin s
S udy 1 (N=38) IP 35 3 0
SPF15 29 8 1
S udy 2 (N=27) IP 22 5 0
SPF50+ 20 6 1
Abb e ia ions: IP, in es iga ional p oduc ; SPF, sun p o ec ion ac o .
Table 3 Clinical e y hema sco ing esul s om s udy 1 ( s SPF15)
Clinical sco e,
a
mean±SD
Baseline T24
b
Mean % change
IP 3.05±1.43 3.08±1.30 ↑6%±24% P=0.65 s baseline
c
Re e ence SPF15 2.89±1.37 3.16±1.26 ↑16%±32% P<0.01 s baseline
c
P=0.02 s e e ence SPF15
c
No es:
a
Scale o 0–9.
b
T24=20±4 h s om he end o sola exposu e pe iod.
c
Wilcoxon signed ank es ; P<0.05 s a is ically significan .
Abb e ia ions: IP, in es iga ional p oduc ; SPF, sun p o ec ion ac o .
Table 4 Clinical e y hema sco ing esul s om s udy 2 ( s SPF50+)
Clinical sco e,
a
mean±SD
Baseline T24
b
Mean % change
IP 0.3±0.5 0.5±0.6 ↑5%±10% P=0.06 s baseline
c
Re e ence SPF50+ 0.4±0.5 0.7±0.6 ↑7%±14% NP
P=0.14 s e e ence SPF50+
c
No es:
a
Scale o 0–4.
b
T24=20±4 h s om he end o sola exposu e pe iod.
c
Wilcoxon signed ank es ; P<0.05 s a is ically significan .
Abb e ia ions: IP, in es iga ional p oduc ; NP, no pe o med; SPF, sun p o ec ion ac o .
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ecommended 2 mg/cm
2
). Ou s udy, in compa ison, had some
no dissimila findings in ha he in es iga ional SPF50+
p oduc was supe io in e ficacy o he SPF15 con ol p oduc ;
howe e , in con as o he p e ious s udy, his di e ence
canno be a ibu ed o subop imal use, since bo h p oduc s
we e applied by a ained echnician a 2 mg/cm
2
and eapplied
a app oxima ely 2 hou ly in e als (a mean 1.7 imes in he 4-
h s udy and 3.2 imes in he 6-h s udy).
The s udies epo ed he e demons a e ha he p oduc
p o ec s agains e y hema, which is known o be induced
p incipally by UVB and UVA-II adia ion.
2
Al hough ou
s udy ook place ou doo s, and he e o e included he ull
na u ally occu ing ange o ligh , i did no specifically
assess UVA-induced damage; howe e , he IP has an
in i o UVA p o ec ion ac o o 20.3.
One limi a ion o he s udy design is ha he wo
clinical assessmen s used di e en scales (0–9 and 0–4,
espec i ely). Use o he same scale in bo h s udies would
ha e allowed a clea e di ec compa ison o esul s. This
di e ence was due o he wo s udies being conduc ed by
wo independen con ac esea ch o ganiza ions, and he
ac ha he e is no es ablished s anda d scale o quan i-
fica ion o sola -induced e y hema. Howe e , a p e ious
s udy
23
concluded ha such isual me hods, namely, a 10-
poin scale, we e “sensi i e, eliable and ep oducible
wi hin a es ing ins i u ion”. I is in e es ing o no e ha ,
while a 10-poin scale may be desc ibed as mo e sensi i e
han a 5-poin scale, and did indeed pick up a change in
SPF15- ea ed skin, i s use did no esul in finding
a significan change in IP- ea ed skin in he same s udy.
The in e p e a ion o he esul s can be applied o
simila se ings, ha is, hose pe mi ing a a ie y o
quie ou doo ac i i ies. Fu he s udies a e planned o
assess he p oduc ’se ficacy unde ex eme UV condi ions,
and he p oduc has p e iously unde gone es ing in we -
skin, wi h a esul simila o ha in he s anda d SPF
es ing (unpublished da a).
The esul s o hese ou doo s udies also demons a e
ha he s udy design used was able o disc imina e
be ween an SPF15 sunsc een and he in es iga ional
SPF50+ sunsc een in e ms o clinical pho op o ec i e
capaci y.
This wa e -based b oad-spec um SPF50+ sunsc een has
been demons a ed o p o ide e y high p o ec ion agains
sola -induced e y hema. Na u ally, his does no ab oga e
he es ablished sun-sa e ad ice o con inue o seek shade
and use p o ec i e clo hing; a he , his p oduc can powe -
ully bols e such app oaches, and along wi h ongoing use
educa ion,
29
op imize sola skin p o ec ion.
30,31
As sunsc-
een is o en he main p e en i e s a egy employed,
29
i is
essen ial ha he p oduc used be as highly e ec i e as
possible and ha he ex u e o he o mula ion encou age
adequa e and equen eapplica ion o he p oduc . As
Wang e al
32
concluded, he bes sunsc een is he one ha
is ac ually used.
Conclusion
In ou doo condi ions in Medi e anean summe sun, his
wa e -based b oad-spec um SPF50+ sun p o ec ion p oduc
had a e y high pho op o ec i e e ec : a le el compa able o
an exis ing SPF50+ sunsc een and supe io o he SPF15
e e ence sunsc een, e en in pho o ype III and IV skin.
Acknowledgmen s
A medical w i e (J. Ma shall) assis ed in d a ing he
manusc ip . The au ho s would like o acknowledge he
Spanish Me eo ological Se ice o he p o ision o he
adia ion measu emen s.
Disclosu e
CG and CT a e employees o ISDIN, who manu ac u ed he
p oduc and sponso ed he s udy. The au ho s epo no o he
conflic s o in e es in his wo k.
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