The impact of current investigational drugs for acne on future treatment strategies

References

• Zaenglein AL, Pathy AL, Schlosser BJ, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016;74(5):945–973.e33.
   PubMed Web of Science ®Google Scholar
• Thiboutot DM, Dréno B, Abanmi A, et al. Practical management of acne for clinicians: an international consensus from the Global Alliance to improve outcomes in acne. J Am Acad Dermatol. 2018;78(2):S1–S23.1.
   PubMed Web of Science ®Google Scholar
• Gollnick H, Cunliffe W, Berson D, et al. Management of acne. J Am Acad Dermatol. 2003;49(1):S1–S37. doi: 10.1067/mjd.2003.618
   PubMed Web of Science ®Google Scholar
• Gebauer K. Acne in adolescents. Aust Fam Physician. 2017;46(12):892–895.
   PubMedGoogle Scholar
• Tan J, Kang S, Leyden J. Prevalence and risk factors of acne scarring among patients consulting dermatologists in the USA. J Drugs Dermatol. 2017;16(2):97–102.
   PubMed Web of Science ®Google Scholar
• Bhate K, Williams HC. Epidemiology of acne vulgaris: Epidemiology of acne vulgaris. Br J Dermatol. 2013;168(3):474–485. doi: 10.1111/bjd.12149
   PubMed Web of Science ®Google Scholar
• Valente Duarte De Sousa IC. New and emerging drugs for the treatment of acne vulgaris in adolescents. Expert Opin Pharmacother. 2019;20(8):1009–1024. doi: 10.1080/14656566.2019.1584182
   PubMed Web of Science ®Google Scholar
• Baldwin H, Tan J. Effects of diet on acne and its response to treatment. Am J Clin Dermatol. 2021;22(1):55–65. doi: 10.1007/s40257-020-00542-y
   PubMed Web of Science ®Google Scholar
• Zouboulis CC, Dessinioti C, Tsatsou F, et al. Anti-acne drugs in phase 1 and 2 clinical trials. Expert Opin Investig Drugs. 2017;26(7):813–823. doi: 10.1080/13543784.2017.1337745
   PubMed Web of Science ®Google Scholar
• Mavranezouli I, Daly CH, Welton NJ, et al. A systematic review and network meta-analysis of topical pharmacological, oral pharmacological, physical and combined treatments for acne vulgaris. Br J Dermatol. 2022 Nov;187(5):639–649. Epub 2022 Aug 22. PMID: 35789996; PMCID: PMC9804728. doi: 10.1111/bjd.21739
   PubMed Web of Science ®Google Scholar
• Lupu R, Menendez J. Pharmacological inhibitors of fatty acid synthase (FASN)-catalyzed endogenous fatty acid biogenesis: a new family of anti-cancer agents? CPB. 2006;7(6):483–494. doi: 10.2174/138920106779116928
   Google Scholar
• Fhu CW, Ali A. Fatty acid synthase: an emerging target in cancer. Molecules. 2020;25(17):3935. doi: 10.3390/molecules25173935
   PubMed Web of Science ®Google Scholar
• Menendez JA, Lupu R. Fatty acid synthase (FASN) as a therapeutic target in breast cancer. Expert Opin Ther Targets. 2017;21(11):1001–1016. doi: 10.1080/14728222.2017.1381087
   PubMed Web of Science ®Google Scholar
• Sagimet Biosciences Inc. Study Of TVB-2640 In Subjects With Nonalcoholic Steatohepatitis (NASH). ClinicalTrials.gov Identifier: NCT04906421. 2021 May. https://clinicaltrials.gov/ct2/show/NCT04906421?term=FASCINATE-2&draw=2&rank=1.
   Google Scholar
• Layton AM, Eady EA, Whitehouse H, et al. Oral spironolactone for acne vulgaris in adult females: a hybrid systematic review. Am J Clin Dermatol. 2017;18(2):169–191. doi: 10.1007/s40257-016-0245-x
   PubMed Web of Science ®Google Scholar
• Hebert A, Thiboutot D, Stein Gold L, et al. Efficacy and safety of topical clascoterone cream, 1%, for treatment in patients with facial acne: two phase 3 randomized clinical trials. JAMA Dermatol. 2020;156(6):621. doi: 10.1001/jamadermatol.2020.0465
   PubMed Web of Science ®Google Scholar
• Rosette C, FJ A, Mazzetti A, et al. Cortexolone 17α-propionate (clascoterone) is a novel androgen receptor antagonist that inhibits production of lipids and inflammatory cytokines from sebocytes in vitro. J Drugs Dermatol. 2019;18(5):412–418.
   PubMed Web of Science ®Google Scholar
• Drake L, Reyes-Hadsall S, Barbieri JS, et al. New developments in topical acne therapy. Am J Clin Dermatol. 2022;23(2):125–136.
   PubMed Web of Science ®Google Scholar
• Mazzetti A, Moro L, Gerloni M, et al. Pharmacokinetic profile, safety, and tolerability of clascoterone (cortexolone 17-alpha propionate, CB-03-01) topical cream, 1% in subjects with acne vulgaris: an open-label phase 2a study. J Drugs Dermatol. 2019;18(6):563.
   PubMed Web of Science ®Google Scholar
• Barbieri JS. A new class of topical acne treatment addressing the hormonal pathogenesis of acne. JAMA Dermatol. 2020;156(6):619–620. doi: 10.1001/jamadermatol.2020.0464
   PubMed Web of Science ®Google Scholar
• Suzhou Kintor Pharmaceutical Inc. A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose Escalation Study In Subjects To Evaluate The Safety, Tolerability And Pharmacokinetics Of GT20029 Following Topical Single And Multiple Ascending Dose Administration. ClinicalTrials.gov Identifier: NCT05428449. [cited 2022 Jun 23]. Available from: https://clinicaltrials.gov/ct2/show/NCT05428449.
   Google Scholar
• Wang Y, Hata TR, Tong YL, et al. The Anti-Inflammatory Activities of Propionibacterium acnes CAMP Factor-Targeted Acne Vaccines. J Invest Dermatol. 2018 Nov;138(11):2355–2364. Epub 2018 Jun 30. PMID: 29964032. doi: 10.1016/j.jid.2018.05.032
   PubMed Web of Science ®Google Scholar
• Ivezic-Schoenfeld Z. A phase I, multi-center, double-blind, randomized, dose escalating, Parallel Group, placebo-controlled safety, tolerability and immunogenicity study of ORI-A-ce001 for the treatment of facial acne vulgaris. ClinicalTrials.gov Identifier: NCT05131373. 2022 Jul 11. https://clinicaltrials.gov/ct2/show/NCT05131373.
   Google Scholar
• Ling JM, Schryvers AB. Perspectives on interactions between lactoferrin and bacteria. Biochem Cell Biol. 2006 Jun;84(3):275–281. PMID: 16936797. doi: 10.1139/o06-044
   PubMedGoogle Scholar
• Chan H, Chan G, Santos J, et al. A randomized, double-blind, placebo-controlled trial to determine the efficacy and safety of lactoferrin with vitamin E and zinc as an oral therapy for mild to moderate acne vulgaris. Int J Dermatol. 2017 Jun;56(6):686–690. Epub 2017 Mar 30. PMID: 28369875. doi: 10.1111/ijd.13607
   PubMed Web of Science ®Google Scholar
• Lim J. (2021 Dec). A Randomized, Double-Blind, Placebo-Controlled Trial To Determine The Safety And Efficacy Of Lactoferrin With Vitamin E And Zinc As An Oral Therapy For Mild To Moderate Hormonal Acne In Adult Women. Identifier NCT05151055. https://clinicaltrials.gov/ct2/show/NCT05151055.
   Google Scholar
• Rezk M, Dawood R, Abo-Elnasr M, et al. RETRACTED ARTICLE: lactoferrin versus ferrous sulphate for the treatment of iron deficiency anemia during pregnancy: a randomized clinical trial. J Matern Neonatal Med. 2016;29(9):1387–1390. doi: 10.3109/14767058.2015.1049149
   PubMed Web of Science ®Google Scholar
• Paesano R, Torcia F, Berlutti F, et al. Oral administration of lactoferrin increases hemoglobin and total serum iron in pregnant womenThis paper is one of a selection of papers published in this special issue, entitled 7th international conference on lactoferrin: structure, function, and applications, and has undergone the Journal’s usual peer review process. Biochem Cell Biol. 2006;84(3):377–380.
   PubMed Web of Science ®Google Scholar
• Hwang J, Rick J, Hsiao J, et al. A review of IL-36: an emerging therapeutic target for inflammatory dermatoses. J Dermatological Treat. 2022;33(6):2711–2722. doi: 10.1080/09546634.2022.2067819
   PubMed Web of Science ®Google Scholar
• Fukaura R, Akiyama M. Targeting IL-36 in inflammatory skin diseases. BioDrugs. Published online Mar 3, 2023;37(3):279–293. doi: 10.1007/s40259-023-00587-5
   PubMed Web of Science ®Google Scholar
• AnaptysBio, Inc. A phase 2, randomized, double-blind, placebo controlled study to evaluate the efficacy and safety of imsidolimab (ANB019) in the treatment of subjects with acne vulgaris. 2021 September ClinicalTrials.gov Identifier: NCT04856917. 2021 Apr. https://clinicaltrials.gov/ct2/show/NCT04856917
   Google Scholar
• Dermata Therapeutics. A study of tolerability, safety, and efficacy, of DMT310 in patients with acne vulgaris. 2020 June ClinicalTrials.gov Identifier: NCT03536637. 2018 May. https://clinicaltrials.gov/ct2/show/NCT03536637
   Google Scholar
• Fitz-Gibbon S, Tomida S, Chiu BH, et al. Propionibacterium acnes strain populations in the human skin microbiome associated with acne. J Invest Dermatol. 2013;133(9):2152–2160. doi: 10.1038/jid.2013.21
   PubMed Web of Science ®Google Scholar
• Johnson T, Kang D, Barnard E, et al. Strain-level differences in porphyrin production and Regulation in propionibacterium acnes elucidate disease associations. D’Orazio SEF, ed. mSphere. 2016;1(1):e00023–15. doi: 10.1128/mSphere.00023-15
   PubMed Web of Science ®Google Scholar
• McDowell A, Barnard E, Nagy I, et al. An expanded multilocus sequence typing scheme for propionibacterium acnes: investigation of ‘pathogenic’, ‘commensal’ and antibiotic resistant strains. PLoS One. 2012;7(7):e41480. Tse H, ed. doi: 10.1371/journal.pone.0041480
   PubMed Web of Science ®Google Scholar
• Tomida S, Nguyen L, Chiu BH, et al. Pan-genome and comparative genome analyses of propionibacterium acnes reveal its genomic diversity in the healthy and diseased human skin microbiome. MBio. 2013;4(3):e00003–13. Blaser MJ, ed. doi: 10.1128/mBio.00003-13
   PubMed Web of Science ®Google Scholar
• Taylor E (2018 Jan – 2020 Aug). A Phase 1B Dose Escalating Study Of The Safety, Short-Term Engraftment And Action Of a Singly-Applied NB01 In Adults With Moderate Acne. ClinicalTrials.gov Identifier: NCT03450369. https://clinicaltrials.gov/ct2/show/NCT03450369
   Google Scholar
• Mohamed Awad S (2019 Sep – 2022 Nov). The Topical Preparations Are Packed In Non-Identifiable Jars And Coded By a Person Who Is Not Involved In The Study The Patient. ClinicalTrials.gov Identifier: NCT04080869. https://clinicaltrials.gov/ct2/show/NCT04080869
   Google Scholar