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

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


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.

Publication types

  • Systematic Review

MeSH terms

  • Biomarkers / analysis
  • Clinical Trials as Topic
  • Dermatologic Agents / therapeutic use*
  • Drug Development / methods*
  • Humans
  • Microbiota*
  • Skin / microbiology*
  • Skin Diseases / diagnosis*
  • Skin Diseases / drug therapy
  • Skin Diseases / microbiology
  • Treatment Outcome


  • Biomarkers
  • Dermatologic Agents