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Methods that is most robust and accurate compared to equivalent in-vivo SPF
tests in predictive in-vitro spf method

Student Name
University
July 31, 2021
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Abstract
The two methods such as the vivo method and in vitro testing of SPF values was
investigated in this study with the objective of evaluating the in vivo robustness of sunscreen
products using in these two methods to reduce labor expenses. The in vivo tests' SPF values were
found to be close to the reported value, suggesting that the SPF values recorded in this study
were reliable more robust. According to the results, there was a significant difference in SPF
values between in vivo and in vitro testing for most products. The results revealed significant
discrepancies between the acquired SPF values and the reference SPF calculated in vivo using
the COLIPA method. The wide range of in vitro outcomes implies that the primary focus should
be on substrate selection that mimics the human skin surface and uniform product application.
When the technical test settings are changed and refined, in vitro screening methods may offer a
rapid and acceptable tool for decreasing the number of in vivo tests and hazards associated with
UV exposure of human participants.

Introduction Sunscreens are among the most

Sunscreens are designed to protect
the skin against the sun's damaging effects,
such as erythema in the short term and
actinic photo-ageing and/or skin cancer in
the long run. The minimal erythemal dosage
is used to determine the efficacy of a
sunscreen for ultraviolet B (UVB) protection
in humans (MED). The test entails putting
the product to a volunteer's skin, exposing
protected and exposed skin to UVR via a
solar simulator, and calculating the
corresponding dosages required to cause
minimal sunburn on protected and
unprotected skin for each volunteer.
Individual SPF is the ratio of these two
doses (SPF = MEDp/MEDu) for each
volunteer, and SPF of the product is the
mean of individual SPFs. The SPF rating on
a product label is critical because it provides
a solid idea of the degree of protection a sun
protection product will provide. The test
technique employed is critical to attaining
reliable labeling. The approach should be
technically sound and laboratory repeatable.
The establishment of a uniform test
technique, as well as standardized SPF
labeling of sun protection goods from
various manufacturers, is a must.
widely used cosmetics. These are
formulations that are applied to the skin's
surface to protect it against ultraviolet (UV)
light's damaging effects. A significant risk
of getting skin cancer has been linked to
repeated skin exposure. According to cancer
research USA, recognizing the damaging
effects of sunlight and how to shield oneself
from the harmful rays can prevent 8 out of
10 occurrences of melanoma. The rise in
holiday sunbathing, as well as the use of
artificial UV sources to promote skin
tanning among young whites desiring a
darker complexion, is causing alarm among
health organizations throughout the world.
Gamma and X rays, for example, are
efficiently filtered out of the planet by the
atmosphere and so have little potential for
harm. It is worth noting, however, that they
are the most deadly, and their exposure
would result in massive tragedies. In this
study, we are going to determine and
evaluate on which predictive in-vitro SPF
method is most robust and accurate
compared to equivalent in-vivo SPF tests.
Methods
Following the PRISMA guidelines,
this study explore the methods in evaluating
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which method we can conclude is more
robust when it comes to prediction of SPF
test. The observational analysis is applied in
this study and for the review of relevant
articles. Both children and adult are
participated in this study with the
presentation of sunscreen application.
Using a standardized data extraction
form, two review authors independently
extracted data from each research. We
gathered the following information: (1)
Study features include the first author's
name, the year of publication, the study's
nation and setting, and the study's sponsor.
(2) Participants: age, gender,
inclusion/exclusion criteria, sampling
method, and sample size (3) Techniques:
research design, exposure categorization
(sunscreen usage), outcome definition
(melanoma, basal cell carcinoma, and
squamous cell carcinoma), data collecting
tools or data source, possible confounders,
and statistical analysis methods; and For
case-control studies, the total number of
participants, number of participants in
exposed and non-exposed groups, number of
persons with skin cancer in each group,
crude and/or adjusted odds ratio (OR), and
95 percent confidence intervals (95 percent
CI); for cross-sectional studies and cohort
studies, the total number of participants,
number of participants in exposed and non-
exposed groups, number of persons with
skin cancer in each group, crude and/or
adjusted odds ratio (OR), and 95 percent
confidence intervals (95 percent. The height
(meters above sea level) and latitude
(degrees from the equator) of the location
were determined.
The I2 statistic, which runs from 0 to
100 percent, was used to measure the
heterogeneity of results between studies,
with values of 25%, 50%, and 75%
corresponding to low, moderate, and high
heterogeneity, respectively. We conducted
previous subgroup analyses based on type of
skin cancer, research design, sampling
technique, correction for confounding
variables, age group, date of data collection,
study site latitude, and comparison of
sunscreen usage frequency to examine the
probable causes of heterogeneity. A post-
hoc subgroup analysis based on study
quality was also performed. To determine
the impact of geographical variables
(altitude and latitude) on study location, we
used meta-regression.
Results
For 28 observational studies, the pooled OR
was 1.11 (95 percent CI: 0.93-1.33; I 2 =
90.2 percent). Ten researches found a link
between sunscreen usage and an increased
incidence of melanoma, whereas five studies
found that sunscreen use protects against
melanoma. When just three studies done
before the 1980s, comprising a total of 1,364
people (619 instances of melanoma), a
rather substantial positive relationship
between risk of melanoma and sunscreen
usage was identified “(cumulative OR =
2.35; 95 percent CI: 1.66-3.33).” Since the
early 1980s, the strength of the link between
sunscreen use and skin cancer risk has
steadily weakened, but the link has remained
statistically significant until the analysis
included 13 studies with data collected.
Discussions
With a total of 313,717 individuals, this
systematic review and meta-analysis of 28
observational studies and one community-
based randomized trial found no significant
overall relationship between the incidence of
melanoma and non-melanoma skin cancers
with sunscreen usage. The effects of
sunscreen appeared to be influenced by
geographical latitude, with the higher the
latitude where individuals reside, the less
preventive impact of sunscreen against skin
cancer. Before the 1980s, there was a very
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substantial positive relationship between the
risk of melanoma and the usage of
sunscreen.
Other Information
The improved efficacy of sunscreens in
protecting against solar UV radiation,
particularly UVA rays, and the growing
public awareness of the risk of excessive sun
exposure may explain the constant shift of
the cumulative point estimate of the
association between skin cancer and
sunscreen use towards the null hypothesis
value through the 1990s. These findings
may allay public fears regarding the
increased risk of skin cancer associated with
sunscreen usage, as previously documented
in epidemiological research. Despite seven
new trials completed in the 2000s, the
cumulative meta-analysis did not
demonstrate the predicted preventive
advantages of sunscreen against skin cancer.
This raises the question of whether or not
using sunscreens is effective in preventing
skin cancer.
The quality of evidence given by this review
could only be described as poor, owing to
inconsistencies in study results,
retrospective design, and the possibility of
bias (selection bias, information bias, and
confounding variables) in the majority of
primary investigations. Given the low
quality of existing data and the availability
of new broad-spectrum sunscreens that
effectively block both UVA and UVB for
more than two decades, it is time to study
the impact of new broad-spectrum
sunscreens on skin cancer prevention in the
general population. Randomized controlled
trials are the “gold standard” for determining
an intervention's efficacy. However, a
strategy like this needs a big sample size and
a long trial period. Furthermore, the study
outcomes are restricted in their application
to the broader population. Prospective,
population-based observational studies in
the actual world would be ideal alternatives.
Data on sunscreen usage and application
appropriateness should be collected in future
investigations (amount of sunscreen applied
and reapplication). Confounding factors
such genetic predisposition, behavior and
lifestyle habits, socioeconomic level, solar
sensitivity, sun exposure, and usage of
alternative sun protection methods were
examined.
References
1. Food and Drug Administration. 1993.
Sunscreen drug products for over-the-
counter human use; tentative final
monograph; proposed rule. Federal Register
58/90, 28194-302. U.S.A.
3. Deutsches Institut fur Normung.
Experimentelle dermatologische Bewertung
des Erythemschutzes von externen
Sonnenschutzmitteln fur die menschliche
Haut. DIN 67501 (1984).
4. Ferguson, J. 1990. European Guidelines
(COLIPA) for Evaluation of Sun Protection
Factors. 25: 513-525.
5. Ferguson, J., Brown, M. and Alert, D.
1996. Collaborative development of a sun
protection factor test method: a proposed
European standard Test Method. COLIPA
Task Force ëSun Protection Measurementí,
Europe. 18: 203-218.
6. (JCIA) Japan Cosmetic Industry
Association. 1991. Standard SPF Test
Method.
7. Food and Drug Administration. 1999.
Sunscreen drug products for over-the
counter human use: final monograph; rules
and regulations, Federal Register. 64(98):
27666-27693.