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. 2018 Oct;84(10):2178-2193.
doi: 10.1111/bcp.13662. Epub 2018 Jul 19.

A systematic literature review of the human skin microbiome as biomarker for dermatological drug development

T Niemeyer-van der Kolk  1   2 , H E C van der Wall  1 , C Balmforth  1 , M B A Van Doorn  1   2 , R Rissmann  1   3   4
Affiliations

A systematic literature review of the human skin microbiome as biomarker for dermatological drug development

T Niemeyer-van der Kolk et al. Br J Clin Pharmacol. 2018 Oct.

Abstract

Aims: To explore the potential of the skin microbiome as biomarker in six dermatological conditions: atopic dermatitis (AD), acne vulgaris (AV), psoriasis vulgaris (PV), hidradenitis suppurativa (HS), seborrhoeic dermatitis/pityriasis capitis (SD/PC) and ulcus cruris (UC).

Methods: A systematic literature review was conducted according to the PRISMA guidelines. Two investigators independently reviewed the included studies and ranked the suitability microbiome implementation for early phase clinical studies in an adapted GRADE method.

Results: In total, 841 papers were identified and after screening of titles and abstracts for eligibility we identified 42 manuscripts that could be included in the review. Eleven studies were included for AD, five for AV, 10 for PV, two for HS, four for SD and 10 for UC. For AD and AV, multiple studies report the relationship between the skin microbiome, disease severity and clinical response to treatment. This is currently lacking for the remaining conditions.

Conclusion: For two indications - AD and AV - there is preliminary evidence to support implementation of the skin microbiome as biomarkers in early phase clinical trials. For PV, UC, SD and HS there is insufficient evidence from the literature. More microbiome-directed prospective studies studying the effect of current treatments on the microbiome with special attention for patient meta-data, sampling methods and analysis methods are needed to draw more substantial conclusions.

Keywords: biomarkers; clinical drug development; microbiota; surrogate parameter.

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Figure 1
Flowchart of the study
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References

    1. Atkinson AJ, Colburn WA, DeGruttola VG, DeMets DL, Downing GJ, Hoth DF, et al Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther 2001; 69: 89–95. - PubMed
    1. Cohen AF, Burggraaf J, van Gerven JM, Moerland M, Groeneveld GJ. The use of biomarkers in human pharmacology (Phase I) studies. Annu Rev Pharmacol Toxicol 2015; 55: 55–74. - PubMed
    1. Lee JW, Weiner RS, Sailstad JM, Bowsher RR, Knuth DW, O'Brien PJ, et al Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development: a conference report. Pharm Res 2005; 22: 499–511. - PubMed
    1. de Visser SJ, van der Post JP, de Waal PP, Cornet F, Cohen AF, van Gerven JM. Biomarkers for the effects of benzodiazepines in healthy volunteers. Br J Clin Pharmacol 2003; 55: 39–50. - PMC - PubMed
    1. Human Microbiome Project C . A framework for human microbiome research. Nature 2012; 486: 215–221. - PMC - PubMed

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