Evidence map›Paper›PMID 36173595›Full record

ArticleDermatology and therapy2022

Evaluation of a Sunscreen Product Compared with Reference Standards P3, P5 and P8 in Outdoor Conditions: a Randomized, Double-Blinded, Intra-individual Study in Healthy Subjects.

Corinne Granger, Gitanjali Petkar, Muzzammil Hosenally, Javier Bustos, Carles Trullàs, Thierry Passeron, Jean Krutmann

Abstract read
In one paragraph

Article in Dermatology and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Corinne GrangerStella Polaris Europe, Paris, France.ORCID http://orcid.org/0000-0001-5117-448X
Gitanjali PetkarCentre International de Développement Pharmaceutique, Phoenix, Mauritius.ORCID http://orcid.org/0000-0003-3700-2256
Muzzammil HosenallyCentre International de Développement Pharmaceutique, Phoenix, Mauritius.ORCID http://orcid.org/0000-0001-7778-9482
Javier BustosInnovation and Development, ISDIN, Barcelona, Spain.ORCID http://orcid.org/0000-0001-6892-4814
Carles TrullàsInnovation and Development, ISDIN, Barcelona, Spain. carles.trullas@isdin.com.ORCID http://orcid.org/0000-0003-1925-5102
Thierry PasseronDepartment of Dermatology, CHU Nice, University Côte d'Azur, Nice, France.ORCID http://orcid.org/0000-0002-0797-6570
Jean KrutmannIUF Leibniz Research Institute for Environmental Medicine, Dusseldorf, Germany.ORCID http://orcid.org/0000-0001-8433-1517

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe shortcomings of standardized sunscreen testing have been discussed in recent years, noting differences between how sunscreens perform in indoor clinical (in vivo) laboratory testing compared with real-life conditions. We previously developed an outdoor clinical method for ranking sunscreens by performance level. We used this method to test the performance of a new broad-spectrum sunscreen against International Organization for Standardization (ISO) reference products P3, P5 and P8.

methodsSixty-five healthy volunteers with individual typology angle (ITA) ≥ 28° (light to intermediate skin colour) participated in an outdoor study in Mauritius. Test areas were marked on their backs, which were treated with the different products: one commercially available broad-spectrum sun protection factor (SPF) 50 sunscreen [investigational product (IP)] and the three reference products P3 (SPF 15), P5 (SPF 30) and P8 (SPF 50+) from ISO norm 24444:2019 for SPF testing. The test areas were exposed for 2-3 h, depending on the baseline skin colour. They were also compared with an unprotected positive control area and a non-exposed negative control area. Clinical and colorimetry assessment of erythema and pigmentation were performed at 24 h and 8 days, respectively.

resultsOverall, according to this outdoor clinical testing method, the sunscreens' efficacy was ranked in an appropriate order given their established SPF levels, with higher SPFs giving greater protection against erythema and pigmentation. Between the different levels of SPF, the differences were statistically significant, for both clinical and colorimetry assessments. The new broad-spectrum SPF 50 IP performed similarly to the SPF 50+ (P8) reference product. Even the highest SPF products, SPF 50 and SPF 50+, had some instances of photoprotection failure.

conclusionThese findings confirm the feasibility of this outdoor clinical testing method in ranking sunscreens and provide further evidence, in addition to standardized SPF and UVA protection factor (UVAPF) testing, on how this new broad-spectrum SPF 50 sunscreen performs in extreme outdoor solar exposure: in line with reference product P8 (SPF 50+). TRIAL REGISTRATION NO: ISRCTN95394014.

Indexed as

ExtremeOutdoor conditionsSpectrumSPFUV index

Identifiers

PMID36173595
PMCPMC9588103

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.