A Randomized Clinical Trial to Evaluate the Efficacy of an Oral Probiotic in Acne Vulgaris

Authors

  • Cristina Eguren Department of Dermatology, Eguren Dermatology and Aesthetics Clinic, Madrid, Spain
  • Ariadna Navarro-Blasco Department of Dermatology, Dermatological and Aesthetic Center, Alicante, Spain
  • Marina Corral-Forteza Department of Dermatology, University Hospital Sagrat Cor, Barcelona, Spain
  • Alejandra Reolid-Pérez Department of Dermatology, Eguren Dermatology and Aesthetics Clinic, Madrid, Spain
  • Núria Setó-Torrent Department of Dermatology, University Hospital Sagrat Cor, Barcelona, Spain
  • Alejandro García-Navarro Department of Dermatology, Dermatological and Aesthetic Center, Alicante, Spain
  • David Prieto-Merino Faculty of Medicine, University of Alcalá de Henares, Madrid, Spain
  • Eva Núñez-Delegido Faculty of Medicine, Catholic University of Murcia (UCAM), Murcia, Spain
  • Pedro Sánchez-Pellicer Faculty of Medicine, Catholic University of Murcia (UCAM), Murcia, Spain
  • Vicente Navarro-López Faculty of Medicine, Catholic University of Murcia (UCAM), Murcia, Spain; Department of Internal Medicine, University Hospital Vinalopó-Fisabio, Elche, Spain

DOI:

https://doi.org/10.2340/actadv.v104.33206

Keywords:

Acne Vulgaris, Dermatology, Clinical Study, Microbiota, Probiotics.

Abstract

The relevance of the gut microbiota in some skin inflammatory diseases, including acne vulgaris, has been emphasized. Probiotics could play a role in the modulation of the microbiota, improving the clinical course of this disease. A 12-week randomized, double-blind, placebo-controlled, clinical trial with patients aged 12 to 30 years with acne vulgaris was conducted. The study product was a capsule composed of the probiotic Lacticaseibacillus rhamnosus (CECT 30031) and the cyanobacterium Arthrospira platensis (BEA_IDA_0074B). Patients with improvement in the Acne Global Severity Scale were 10/34 (29.41%) in the placebo group compared with 20/40 (50%) in the probiotic group (p = 0.03). A significant reduction (p = 0.03) in the number of non-inflammatory acne lesions was observed in the probiotic group (–18.60 [–24.38 to –12.82]) vs the placebo group (–10.54 [–17.43 to –3.66]). Regarding the number of total  lesions, a reduction almost reaching statistical significance (p = 0.06) was observed in the probiotic group (–27.94 [–36.35 to –19.53]) compared with the placebo group (–18.31 [–28.21 to –8.41]). In addition, patients with improvement attending the Global Acne Grading System were 7/34 (20.58%) in the placebo group vs 17/40 (42.50%) in the probiotic group (p = 0.02). The number of adverse events was similar in both groups. The probiotic used in this study was effective and well tolerated, and it should be considered for acne vulgaris patients.

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References

Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380: 2163-2196.

https://doi.org/10.1016/S0140-6736(12)61729-2 DOI: https://doi.org/10.1016/S0140-6736(12)61729-2

Heng AHS, Chew FT. Systematic review of the epidemiology of acne vulgaris. Sci Rep 2020; 10: 5754.

https://doi.org/10.1038/s41598-020-62715-3 DOI: https://doi.org/10.1038/s41598-020-62715-3

Bhate K, Williams HC. Epidemiology of acne vulgaris. Br J Dermatol 2013; 168: 474-485.

https://doi.org/10.1111/bjd.12149 DOI: https://doi.org/10.1111/bjd.12149

Sánchez-Pellicer P, Navarro-Moratalla L, Núñez-Delegido E, Ruzafa-Costas B, Agüera-Santos J, Navarro-López V. Acne, microbiome, and probiotics: the gut-skin axis. Microorganisms 2022; 10: 1303.

https://doi.org/10.3390/microorganisms10071303 DOI: https://doi.org/10.3390/microorganisms10071303

Ottaviani M, Camera E, Picardo M. Lipid mediators in acne. Mediators Inflamm 2010; 2010: 858176.

https://doi.org/10.1155/2010/858176 DOI: https://doi.org/10.1155/2010/858176

Hu T, Wei Z, Ju Q, Chen W. Sex hormones and acne: state of the art. J Dtsch Dermatol Ges 2021; 19: 509-515.

https://doi.org/10.1111/ddg.14426 DOI: https://doi.org/10.1111/ddg.14426

Melnik BC. Linking diet to acne metabolomics, inflammation, and comedogenesis: an update. Clin Cosmet Investig Dermatol 2015; 8: 371-388.

https://doi.org/10.2147/CCID.S69135 DOI: https://doi.org/10.2147/CCID.S69135

Kwon HH, Yoon JY, Park SY, Suh DH. Analysis of distribution patterns of Propionibacterium acnes phylotypes and Peptostreptococcus species from acne lesions. Br J Dermatol 2013; 169: 1152-1155.

https://doi.org/10.1111/bjd.12486 DOI: https://doi.org/10.1111/bjd.12486

Barnard E, Shi B, Kang D, Craft N, Li H. The balance of metagenomic elements shapes the skin microbiome in acne and health. Sci Rep 2016; 6: 39491.

https://doi.org/10.1038/srep39491 DOI: https://doi.org/10.1038/srep39491

Johnson T, Kang D, Barnard E, Li H. Strain-level differences in porphyrin production and regulation in propionibacterium acnes elucidate disease associations. mSphere 2016; 1: e00023-15.

https://doi.org/10.1128/mSphere.00023-15 DOI: https://doi.org/10.1128/mSphere.00023-15

Coenye T, Spittaels KJ, Achermann Y. The role of biofilm formation in the pathogenesis and antimicrobial susceptibility of cutibacterium acnes. Biofilm 2022; 4: 100063.

https://doi.org/10.1016/j.bioflm.2021.100063 DOI: https://doi.org/10.1016/j.bioflm.2021.100063

Jahns AC, Lundskog B, Ganceviciene R, Palmer RH, Golovleva I, Zouboulis CC, et al. An increased incidence of Propionibacterium acnes biofilms in acne vulgaris: a case-control study. Br J Dermatol 2012; 167: 50-58.

https://doi.org/10.1111/j.1365-2133.2012.10897.x DOI: https://doi.org/10.1111/j.1365-2133.2012.10897.x

Yu Y, Champer J, Agak GW, Kao S, Modlin RL, Kim J. Different Propionibacterium acnes phylotypes induce distinct immune responses and express unique surface and secreted proteomes. J Invest Dermatol 2016;1 36: 2221-2228.

https://doi.org/10.1016/j.jid.2016.06.615 DOI: https://doi.org/10.1016/j.jid.2016.06.615

Nast A, Dréno B, Bettoli V, Bukvic Mokos Z, Degitz K, Dressler C, et al. European evidence-based (S3) guideline for the treatment of acne - update 2016 - short version. J Eur Acad Dermatol Venereol 2016; 30: 1261-1268.

https://doi.org/10.1111/jdv.13776 DOI: https://doi.org/10.1111/jdv.13776

Walsh TR, Efthimiou J, Dréno B. Systematic review of antibiotic resistance in acne: an increasing topical and oral threat. Lancet Infect Dis 2016; 16: e23-33.

https://doi.org/10.1016/S1473-3099(15)00527-7 DOI: https://doi.org/10.1016/S1473-3099(15)00527-7

Garner SE, Eady A, Bennett C, Newton JN, Thomas K, Popescu CM. Minocycline for acne vulgaris: efficacy and safety. Cochrane Database Syst Rev 2012; 2012: CD002086.

https://doi.org/10.1002/14651858.CD002086.pub2 DOI: https://doi.org/10.1002/14651858.CD002086.pub2

Salem I, Ramser A, Isham N, Ghannoum MA. The gut microbiome as a major regulator of the gut-skin axis. Front Microbiol 2018; 9: 1459.

https://doi.org/10.3389/fmicb.2018.01459 DOI: https://doi.org/10.3389/fmicb.2018.01459

Gilbert JA, Blaser MJ, Caporaso JG, Jansson JK, Lynch SV, Knight R. Current understanding of the human microbiome. Nat Med 2018; 24: 392-400.

https://doi.org/10.1038/nm.4517 DOI: https://doi.org/10.1038/nm.4517

Wensel CR, Pluznick JL, Salzberg SL, Sears CL. Next-generation sequencing: insights to advance clinical investigations of the microbiome. J Clin Invest 2022; 132: e154944.

https://doi.org/10.1172/JCI154944 DOI: https://doi.org/10.1172/JCI154944

Deng Y, Wang H, Zhou J, Mou Y, Wang G, Xiong X. Patients with acne vulgaris have a distinct gut microbiota in comparison with healthy controls. Acta Derm Venereol 2018; 98: 783-790.

https://doi.org/10.2340/00015555-2968 DOI: https://doi.org/10.2340/00015555-2968

Huang Y, Liu L, Chen L, Zhou L, Xiong X, Deng Y. Gender-specific differences in gut microbiota composition associated with microbial metabolites for patients with acne vulgaris. Ann Dermatol 2021; 33: 531-540.

https://doi.org/10.5021/ad.2021.33.6.531 DOI: https://doi.org/10.5021/ad.2021.33.6.531

Koh A, De Vadder F, Kovatcheva-Datchary P, Bäckhed F. From dietary fiber to host physiology: short-chain fatty acids as key bacterial metabolites. Cell 2016; 165: 1332-1345.

https://doi.org/10.1016/j.cell.2016.05.041 DOI: https://doi.org/10.1016/j.cell.2016.05.041

Kim CH. Control of lymphocyte functions by gut microbiota-derived short-chain fatty acids. Cell Mol Immunol 2021; 18: 1161-1171.

https://doi.org/10.1038/s41423-020-00625-0 DOI: https://doi.org/10.1038/s41423-020-00625-0

Usuda H, Okamoto T, Wada K. leaky gut: effect of dietary fiber and fats on microbiome and intestinal barrier. Int J Mol Sci 2021; 22: 7613.

https://doi.org/10.3390/ijms22147613 DOI: https://doi.org/10.3390/ijms22147613

Navarro-López V, Núñez-Delegido E, Ruzafa-Costas B, Sánchez-Pellicer P, Agüera-Santos J, Navarro-Moratalla L. Probiotics in the therapeutic arsenal of dermatologists. Microorganisms 2021; 9: 1513.

https://doi.org/10.3390/microorganisms9071513 DOI: https://doi.org/10.3390/microorganisms9071513

Jung GW, Tse JE, Guiha I, Rao J. Prospective, randomized, open-label trial comparing the safety, efficacy, and tolerability of an acne treatment regimen with and without a probiotic supplement and minocycline in subjects with mild to moderate acne. J Cutan Med Surg 2013; 17: 114-122.

https://doi.org/10.2310/7750.2012.12026 DOI: https://doi.org/10.2310/7750.2012.12026

Fabbrocini G, Bertona M, Picazo Ó, Pareja-Galeano H, Monfrecola G, Emanuele E. Supplementation with Lactobacillus rhamnosus SP1 normalises skin expression of genes implicated in insulin signalling and improves adult acne. Benef Microbes 2016; 7: 625-630.

https://doi.org/10.3920/BM2016.0089 DOI: https://doi.org/10.3920/BM2016.0089

Tolino E, Skroza N, Mambrin A, Bernardini N, Zuber S, Balduzzi V, et al. Novel combination for the treatment of acne differentiated based on gender: a new step towards personalized treatment. G Ital Dermatol Venereol 2018; 153: 866-871.

https://doi.org/10.23736/S0392-0488.18.05710-3 DOI: https://doi.org/10.23736/S0392-0488.18.05710-3

Manzhalii E, Hornuss D, Stremmel W. Intestinal-borne dermatoses significantly improved by oral application of Escherichia coli Nissle 1917. World J Gastroenterol 2016; 22: 5415-5421.

https://doi.org/10.3748/wjg.v22.i23.5415 DOI: https://doi.org/10.3748/wjg.v22.i23.5415

Rinaldi F, Marotta L, Mascolo A, Amoruso A, Pane M, Giuliani G, et al. Facial acne: a randomized, double-blind, placebo-controlled study on the clinical efficacy of a symbiotic dietary supplement. Dermatol Ther (Heidelb) 2022; 12: 577-589.

https://doi.org/10.1007/s13555-021-00664-z DOI: https://doi.org/10.1007/s13555-021-00664-z

Chen L, Li H, Li J, Chen Y, Yang Y. Lactobacillus rhamnosus GG treatment improves intestinal permeability and modulates microbiota dysbiosis in an experimental model of sepsis. Int J Mol Med 2019; 43: 1139-1148.

https://doi.org/10.3892/ijmm.2019.4050 DOI: https://doi.org/10.3892/ijmm.2019.4050

Panpetch W, Hiengrach P, Nilgate S, Tumwasorn S, Somboonna N, Wilantho A, et al. Additional candida albicans administration enhances the severity of dextran sulfate solution induced colitis mouse model through leaky gut-enhanced systemic inflammation and gut-dysbiosis but attenuated by Lactobacillus rhamnosus L34. Gut Microbes 2020; 11: 465-480.

https://doi.org/10.1080/19490976.2019.1662712 DOI: https://doi.org/10.1080/19490976.2019.1662712

Jia L, Wu R, Han N, Fu J, Luo Z, Guo L, et al. Porphyromonas gingivalis and Lactobacillus rhamnosus GG regulate the Th17/Treg balance in colitis via TLR4 and TLR2. Clin Transl Immunology 2020; 9: e1213.

https://doi.org/10.1002/cti2.1213 DOI: https://doi.org/10.1002/cti2.1213

Chen JF, Zhuang Y, Jin SB, Zhang SL, Yang WW. Probiotic lactobacillus rhamnosus GG (LGG) restores intestinal dysbacteriosis to alleviate upregulated inflammatory cytokines triggered by femoral diaphyseal fracture in adolescent rodent model. Eur Rev Med Pharmacol Sci 2021; 25: 376-389.

Nihal B, Gupta NV, Gowda D, Mariapan M. Formulation and development of topical anti acne formulation of spirulina extract. Int J Appl Pharm 2018; 10: 229-233.

https://doi.org/10.22159/ijap.2018v10i6.26334 DOI: https://doi.org/10.22159/ijap.2018v10i6.26334

Dranseikienė D, Balčiūnaitė-Murzienė G, Karosienė J, Morudov D, Juodžiukynienė N, Hudz N, et al. Cyano- phycocyanin: mechanisms of action on human skin and future perspectives in medicine. Plants (Basel) 2022; 11: 1249.

https://doi.org/10.3390/plants11091249 DOI: https://doi.org/10.3390/plants11091249

Kellett SC, Gawkrodger DJ. The psychological and emotional impact of acne and the effect of treatment with isotretinoin. Br J Dermatol 1999; 140: 273-282.

https://doi.org/10.1046/j.1365-2133.1999.02662.x DOI: https://doi.org/10.1046/j.1365-2133.1999.02662.x

Mirdamadi Y, Bommhardt U, Goihl A, Guttek K, Zouboulis CC, Quist S, et al. Insulin and insulin-like growth factor-1 can activate the phosphoinositide-3-kinase /Akt/FoxO1 pathway in T cells in vitro. Dermatoendocrinol 2017; 9: e1356518.

https://doi.org/10.1080/19381980.2017.1356518 DOI: https://doi.org/10.1080/19381980.2017.1356518

Melnik BC. The role of transcription factor FoxO1 in the pathogenesis of acne vulgaris and the mode of isotretinoin action. G Ital Dermatol Venereol 2010; 145: 559-571.

Dall'Oglio F, Nasca MR, Fiorentini F, Micali G. Diet and acne: review of the evidence from 2009 to 2020. Int J Dermatol 2021; 60: 672-685.

https://doi.org/10.1111/ijd.15390 DOI: https://doi.org/10.1111/ijd.15390

Rocha MA, Bagatin E. Adult-onset acne: prevalence, impact, and management challenges. Clin Cosmet Investig Dermatol 2018; 11: 59-69.

https://doi.org/10.2147/CCID.S137794 DOI: https://doi.org/10.2147/CCID.S137794

Published

2024-05-15

How to Cite

Eguren , C., Navarro-Blasco, A. ., Corral-Forteza, M. ., Reolid-Pérez, A. ., Setó-Torrent, N. ., García-Navarro, A. ., Prieto-Merino, D. ., Núñez-Delegido, E. ., Sánchez-Pellicer, P., & Navarro-López, V. (2024). A Randomized Clinical Trial to Evaluate the Efficacy of an Oral Probiotic in Acne Vulgaris. Acta Dermato-Venereologica, 104, adv33206. https://doi.org/10.2340/actadv.v104.33206