ORIGINAL ARTICLE

Inuence of the quantity of sunscreen applied on the ability to protect

against ultraviolet-induced polymorphous light eruption
Robert Bissonnette, Simon Nigen & Chantal Bolduc
Innovaderm Research Inc., Montreal, QC, Canada

Summary
Key words:
polymorphous light eruption; sun
protection factor; sunscreen; UVA
protection

Correspondence:
Dr Robert Bissonnette, MD, FRCPC,
Innovaderm Research Inc., 1851 Sherbrooke East
suite 502, Montreal, Quebec, Canada H2K 4L5.
Tel: +1 514 521 4285 ext 210
Fax: +1 514 906 0659
e-mail: rbissonnette@innovaderm.ca

Accepted for publication:

23 May 2012

Conicts of interest:
This study was sponsored by LOral
Canada. Robert Bissonnette, Simon Nigen
and Chantal Bolduc received research
grants from LOral and Pierre Fabre
Dermocosmtique. Robert Bissonnette
received honoraria as a speaker from
LOral and Pierre-Fabre
Dermocosmtique.

Background/Purpose: Despite the fact that most people apply less sunscreen than the 2 mg/
cm2 required to measure sun protection factor (SPF), there is a lack of clinical data on the
protection afforded from lower applied quantities.The aim of this study was to compare the
ability of sunscreens to protect against UV-induced polymorphous light eruption (PLE)
when applied at 2 mg/cm2 and 1 mg/cm2.
Methods: Two SPF 45 sunscreens (one with a high level and one with a low level of UVA
protection) were applied at 2 mg/cm2 and 1 mg/cm2 to four randomized 6 6 cm areas on
the upper thorax of 15 female patients with a typical history of PLE.The areas were exposed
daily to increasing UVAUVB radiation until a PLE reaction was detected or a maximum of
five consecutive days.
Results: The proportion of patients who developed a PLE reaction with the high UVAprotection sunscreen was significantly lower (0%) than with the low UVA-protection sunscreen (73%) when both sunscreens were applied at 2 mg/cm2 (P = 0.004). At 1 mg/cm2,
33% and 80% of patients presented a PLE reaction with the high and low UVA-protection
sunscreen, respectively (P = 0.064).
Conclusion: A high SPF and high UVA-protection broad spectrum sunscreen was able to
protect the majority of patients from the development of UV-induced PLE reaction even at
1 mg/cm2.

easurement of ultraviolet A (UVA) and ultraviolet B (UVB)

protection afforded by sunscreens is usually performed in
vivo using 2 mg/cm2 as recommended by the Food and Drug
Administration (FDA) for sun protection factor (SPF) testing.The
required use of 2 mg/cm2 for SPF testing has recently been
confirmed by the FDA in their 2011 revised sunscreen labeling
and effectiveness testing regulation (1). According to this document, the decision was based on a greater reproducibility of SPF
test results with the use of 2 mg/cm2 and on the importance of
global harmonization as other countries are using 2 mg/cm2.
However, numerous studies have shown that people commonly
apply sunscreen amount ranging from 0.5 to 1 mg/cm2 and
sometimes even less (25).
Polymorphous light eruption (PLE) is the most frequent idiopathic photodermatosis with an estimated prevalence of up to
10% to 20% of the population in fair-skinned individuals (68).
As a first line therapy to prevent PLE, high SPF sunscreens affording broad range of UVA protection are effective at reducing
or suppressing the appearance of PLE (912). There is a lack of
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clinical data on the ability of sunscreens to protect against photodermatoses when the amount of applied sunscreen is less than
2 mg/cm2. The aim of this study was to compare the ability of
sunscreens to protect against UV-induced PLE when applied at
2 mg/cm2 and 1 mg/cm2.

Methods
Patients
This intraindividual, randomized, comparative, single-blind trial
was performed in one study center in Canada. To be eligible for
the study, patients had to be women, aged between 18 and 45,
with Fitzpatrick skin phototype II or III, and a known history of
typical PLE on the thorax. Before being enrolled in the study, a
washout of 12 weeks for sun exposure on the upper thorax and
of 4 weeks for any medication that could induce photosensitivity
was required.
2012 John Wiley & Sons A/S
Photodermatology, Photoimmunology & Photomedicine 2012, 28, 240243

Sunscreen quantity and polymorphous light eruption

Table 1. Ultraviolet A and B radiations doses
Exposure

UVA dose (J/cm2)

UVB dose (J/cm2)

Day 1
Day 2
Day 3
Day 4
Day 5
Total

30
35
35
40
45
185

0.83
0.96
0.96
1.10
1.24
5.09

UVA, ultraviolet A; UVB, ultraviolet B.

Procedures
The study was approved by an institutional review board, and
written informed consent was obtained from each patient before
beginning any study-related procedures. Two sunscreens were
tested. Sunscreen A (Ombrelle Face Protection SPF 45, LOreal
Canada, Montreal, QC, Canada) contained octocrylene 5%,
Mexoryl SX (teraphthalylidene dicamphor sulfonic acid) 1.5%,
Mexoryl XL (drometrizole trisiloxane) 4%, avobenzone 3%, and
titanium dioxide 3.3%; while sunscreen B (Coppertone Sunblock
lotion SPF 45, Schering-Plough Canada Inc., Kirkland, QC,
Canada) contained homosalate 8%, octinoxate 7.5%, oxybenzone 6%, and octisalate 5%. Sunscreens A and B had critical
wavelengths of 382 and approximately 361, respectively (data on
file LOral).
According to the persistent pigment darkening method, the
UVA protection factors were, respectively, 25 for sunscreen A and
5 for sunscreen B (data on file LOral). Sunscreens A and B were
randomly applied to four 6 6 cm delineated areas on the upper
thorax of each patient. Fifteen minutes after sunscreen application, each of the four areas were exposed to the same doses of
UVA (irradiance 20 mW/cm2) and UVB (irradiance 0.55 mW/
cm2) using a metal Halide Lamp (UVASPOT 400/T, Dr Honle AG
UV Technology, Munich, Germany). Untreated skin was covered
during UV exposure. Repeated daily sunscreen application and
UVA and UVB exposure with identically increasing UV doses to
all areas was performed for five consecutive days (Table 1).

Fig. 1. Cumulative number of patients with ultraviolet (UV)-triggered

polymorphous light eruption (PLE).

exposed to UV and not further assessed for signs of PLE. Safety

was assessed by adverse events evaluation from day 1 to day 5.
Statistical analysis
A sample size of 15 patients had a power of 80% to detect a
difference of 66.8% in the proportion of patients developing a
PLE reaction with the high-protection sunscreen assuming that
83.4% of patients protected by the low protection sunscreen
would develop a PLE reaction using a two-sided McNemar test
with a significance level (alpha) of 0.05.
Two-by-two comparisons were done using McNemar test and
a Bonferroni correction to compare the number of patients who
developed a positive PLE reaction after five consecutive treatments or less. Analyses were performed with SPSS (version 15.0,
SPSS, IBM Corporation, Armonk, NY, USA) and Stata (version 10,
Stata, StataCorp LP, College Station, TX, USA). All patients were
included in the safety and efficacy analyses and the nonresponder
imputation method was used for missing data.

Results
Efcacy and safety evaluations
Five hours after each UV irradiation, a blind assessor evaluated
the presence of PLE signs at each of the exposed areas. Erythema,
papules, vesicles, and edema were individually assessed for each
of the exposed areas, according to the following 4-point severity
scale denoting area of involvement of each sign [0 = no visible
reaction; 1 = slight reaction (less than 15% of the surface
involved); 2 = mild reaction (1530% of the surface involved);
3 = severe reaction (30100% of the surface involved)]. A score
of at least 1 for both erythema and papules was necessary to
consider that PLE was triggered. The PLE severity for each area
was determined by the maximum score for erythema, papules,
vesicles, or edema. For example, a subject with an assessment
of 1 for erythema, 2 for papules, 0 for vesicles, and 1 for edema
would have an overall score of 2 (mild reaction) for that exposed
area. Once PLE was confirmed, the area involved was no longer
2012 John Wiley & Sons A/S
Photodermatology, Photoimmunology & Photomedicine 2012, 28, 240243

Patients
A total of 15 women with a mean age of 33.6 years (1845)
were included in the study. All patients completed the study, but
one patient missed one visit and another missed two visits.There
was no major protocol deviation during this study.
PLE reactions
For each sunscreen and each application, the cumulative number
of patients who had PLE triggered at each study visit is shown
in Fig. 1. When sunscreens were used at 2 mg/cm2, the number
of patients who developed PLE symptoms with sunscreen A
(0%) was significantly lower than with sunscreen B (73%)
(P = 0.004). When sunscreens A and B were used at 1 mg/cm2, a
total of five patients (33%) had a UV-triggered PLE reaction with
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Bissonnette et al.

Fig. 2. Polymorphous light eruption (PLE) severity for each sunscreen

and application rate.

sunscreen A as compared to 12 patients (80%) with sunscreen B.

Although not significant, there was a trend toward a lower
number of patients who presented PLE with sunscreen A
(P = 0.064). There was no significant difference between the
number of patients who presented a PLE reaction when sunscreen A was used at 2 mg/cm2 compared to 1 mg/cm2
(P = 0.252) as well as for sunscreen B used at 2 mg/cm2 compared to 1 mg/cm2 (P = 1.000).
With sunscreen A, the cumulative number of patients who
developed erythema and/or papules with a score of at least 2 was
zero and one when used at 2 and 1 mg/cm2, respectively. With
sunscreen B, the cumulative number of patients who developed
erythema and/or papules with a score of at least 2 was seven and
five when used at 2 and 1 mg/cm2, respectively.
The proportion of patients who developed a slight, mild, or
severe PLE reaction is presented in Fig. 2. With sunscreen A, PLE
reactions of slight intensity (score of 1) only were observed in
five patients (33%) when used at 1 mg/cm2, whereas no patient
presented a PLE reaction at 2 mg/cm2 with sunscreen A. With
sunscreen B, PLE reactions of mild and severe intensity (score of
2 or 3) were observed.The proportion of patients with a score of
2 was 27% and 20% when used at 2 and 1 mg/cm2, respectively.
Also, 6.7% of patients who used sunscreen B at 1 mg/cm2 experienced a PLE reaction of severe intensity (score of 3).
Adverse events
All adverse events reported in this study were evaluated as not
related to study treatment and were mild or moderate in intensity. There was no serious adverse event reported.

Discussion
Sales of sunscreens per individual have increased over the past
decade in the United States (13). Sunscreens with SPF of 50 and
over with UVA protection factors of 30 and more are currently
available in most markets. Patients and consumers have access to
sunscreens offering excellent protection against UVA and UVB
radiation. Despite the availability of these broad spectrum and
high SPF sunscreens, patients often report that their sunscreen
failed to protect against sunburn or PLE. This could be related to
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an inadequate amount of sunscreen applied. Most in vivo sunscreen studies are performed with an amount of 2 mg/cm2
when, unfortunately, studies have shown that consumers are
using much less (25).Various studies have shown that lowering
the amount of sunscreen applied per unit area will lower the SPF.
Whether this relationship is linear or exponential appears to be
controversial (1416).
The present study showed that the high-level UVA protection
sunscreen (sunscreen A) containing a combination of different
UVA filters including photostabilized avobenzone was still able
to prevent UV-induced PLE in most subjects (67%) when used
at 1 mg/cm2. There was no statistically significant difference
between the proportions of patients who presented PLE with the
high-level UVA protection sunscreen at 2 and 1 mg/cm2. These
findings are important as they demonstrate that protection from
UV-induced PLE with a sunscreen providing high-level, broad
spectrum UVA protection is still possible when sunscreens are
used at less than 2 mg/cm2. On the other hand, the proportion of
subjects who presented a UV-induced PLE with the sunscreen
offering a low level of UVA protection applied at 2 and 1 mg/cm2
was fairly similar (73% and 80%, respectively). This suggests
that, in the case of a sunscreen with low UVA protection, the
amount of sunscreen applied is less relevant to prevent PLE and
underlines the importance for these patients of using a sunscreen
with sufficient UVA protection. Previous studies showed that UVA
(320400 nm) radiation is the main triggering factor in PLE
(9, 12, 15, 1721).The current study confirmed the importance
of the UVA protection level of sunscreen and showed that the
amount of sunscreen applied is also an important factor for
prevention of UV-induced PLE.
One of the limitations of the current study is the small sample
size.The power calculation assumed that 83.4% of patients using
sunscreen B would develop a PLE, however only 76.7% did;
suggesting that this 15-patient study was underpowered to detect
statistically significant differences between the four exposed
areas. Future studies are needed with larger sample size. In addition, the light source used in this study was fairly similar to the
UV solar spectrum (22), but did not contain significant amounts
of visible light, which has been shown to trigger idiopathic
dermatoses in some patients (23, 24).
As some patients tend to use a very low amount of sunscreen,
which increases the risks of having unprotected skin areas,
patients should be educated to apply enough sunscreen as a lower
quantity of sunscreen applied per unit area means a lower overall
protection against UV radiation. Some studies have shown that
patients sometimes use as little as 0.39 mg/cm2 and even less. It
is almost impossible to evenly spread a sunscreen when used in
such a low amount, and therefore it does not provide adequate
sun protection over the whole application area (5).
In conclusion, this study showed that a sunscreen with high
SPF offering high and broad spectrum UVA protection was still
able to protect most patients against UV-induced PLE even when
applied at 1 mg/cm2. However, patients must be educated on the
amount of sunscreen to apply as PLE was induced in 33% of
patients when the amount of sunscreen was lowered from 2 to
1 mg/cm2.
2012 John Wiley & Sons A/S
Photodermatology, Photoimmunology & Photomedicine 2012, 28, 240243

Sunscreen quantity and polymorphous light eruption

Acknowledgements
The authors want to thank Sophie Prfontaine Beaupr for her
assistance in writing this manuscript and Miguel Chagnon for his
assistance with statistics.

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