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Clinical Trial Report

Setipiprant for Androgenetic Alopecia in Males: Results from a Randomized, Double-Blind, Placebo-Controlled Phase 2a Trial

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Pages 1507-1517 | Published online: 15 Oct 2021

References

  • Stough D, Stenn K, Haber R, et al. Psychological effect, pathophysiology, and management of androgenetic alopecia in men. Mayo Clin Proc. 2005;80(10):1316–1322. doi:10.4065/80.10.1316
  • Rathnayake D, Sinclair R. Male androgenetic alopecia. Expert Opin Pharmacother. 2010;11(8):1295–1304. doi:10.1517/14656561003752730
  • Cash TF. The psychological effects of androgenetic alopecia in men. J Am Acad Dermatol. 1992;26(6):926–931. doi:10.1016/0190-9622(92)70134-2
  • Kanti V, Messenger A, Dobos G, et al. Evidence-based (S3) guideline for the treatment of androgenetic alopecia in women and in men - short version. J Eur Acad Dermatol Venereol. 2018;32(1):11–22. doi:10.1111/jdv.14624
  • Kanti V, Messenger A, Dobos G, et al. European Dermatology Forum Guideline for the Treatment of Androgenetic Alopecia in Women and in Men. Zurich, Switzerland: European Dermatology Forum; 2017.
  • Rossi A, Anzalone A, Fortuna MC, et al. Multi-therapies in androgenetic alopecia: review and clinical experiences. Dermatol Ther. 2016;29(6):424–432. doi:10.1111/dth.12390
  • Almohanna HM, Perper M, Tosti A. Safety concerns when using novel medications to treat alopecia. Expert Opin Drug Saf. 2018;17(11):1115–1128. doi:10.1080/14740338.2018.1533549
  • Roberts JL, Fiedler V, Imperato-McGinley J, et al. Clinical dose ranging studies with finasteride, a type 2 5alpha-reductase inhibitor, in men with male pattern hair loss. J Am Acad Dermatol. 1999;41(4):555–563.
  • Kaufman KD, Dawber RP. Finasteride, a type 2 5alpha-reductase inhibitor, in the treatment of men with androgenetic alopecia. Expert Opin Investig Drugs. 1999;8(4):403–415. doi:10.1517/13543784.8.4.403
  • Olsen EA, Dunlap FE, Funicella T, et al. A randomized clinical trial of 5% topical minoxidil versus 2% topical minoxidil and placebo in the treatment of androgenetic alopecia in men. J Am Acad Dermatol. 2002;47(3):377–385. doi:10.1067/mjd.2002.124088
  • Nieves A, Garza LA. Does prostaglandin D2 hold the cure to male pattern baldness? Exp Dermatol. 2014;23(4):224–227. doi:10.1111/exd.12348
  • Woodward DF, Liang Y, Krauss AH. Prostamides (prostaglandin-ethanolamides) and their pharmacology. Br J Pharmacol. 2008;153(3):410–419. doi:10.1038/sj.bjp.0707434
  • Khidhir KG, Woodward DF, Farjo NP, et al. The prostamide-related glaucoma therapy, bimatoprost, offers a novel approach for treating scalp alopecias. FASEB J. 2013;27(2):557–567. doi:10.1096/fj.12-218156
  • Johnstone MA, Albert DM. Prostaglandin-induced hair growth. Surv Ophthalmol. 2002;47(Suppl 1):S185–S202. doi:10.1016/S0039-6257(02)00307-7
  • Gandolfi S, Simmons ST, Sturm R, Chen K, VanDenburgh AM. Three-month comparison of bimatoprost and latanoprost in patients with glaucoma and ocular hypertension. Adv Ther. 2001;18(3):110–121. doi:10.1007/BF02850299
  • Kupczyk M, Kuna P. Targeting the PGD2/CRTH2/DP1 signaling pathway in asthma and allergic disease: current status and future perspectives. Drugs. 2017;77(12):1281–1294. doi:10.1007/s40265-017-0777-2
  • Garza LA, Liu Y, Yang Z, et al. Prostaglandin D2 inhibits hair growth and is elevated in bald scalp of men with androgenetic alopecia. Sci Transl Med. 2012;4(126):126ra134. doi:10.1126/scitranslmed.3003122
  • Nelson AM, Loy DE, Lawson JA, Katseff AS, Fitzgerald GA, Garza LA. Prostaglandin D2 inhibits wound-induced hair follicle neogenesis through the receptor, Gpr44. J Invest Dermatol. 2013;133(4):881–889. doi:10.1038/jid.2012.398
  • Fretz H, Valdenaire A, Pothier J, et al. Identification of 2-(2-(1-naphthoyl)-8-fluoro-3,4-dihydro-1H-pyrido[4,3-b]indol-5(2H)-yl)acetic acid (setipiprant/ACT-129968), a potent, selective, and orally bioavailable chemoattractant receptor-homologous molecule expressed on Th2 cells (CRTH2) antagonist. J Med Chem. 2013;56(12):4899–4911.
  • Ratner P, Andrews CP, Hampel FC, et al. Efficacy and safety of setipiprant in seasonal allergic rhinitis: results from Phase 2 and Phase 3 randomized, double-blind, placebo- and active-referenced studies. Allergy Asthma Clin Immunol. 2017;13:18. doi:10.1186/s13223-017-0183-z
  • Willetts L, Ochkur SI, Jacobsen EA, Lee JJ, Lacy P. Eosinophil shape change and secretion. Methods Mol Biol. 2014;1178:111–128.
  • Diamant Z, Sidharta PN, Singh D, et al. Setipiprant, a selective CRTH2 antagonist, reduces allergen-induced airway responses in allergic asthmatics. Clin Exp Allergy. 2014;44(8):1044–1052. doi:10.1111/cea.12357
  • Norwood OT. Male pattern baldness: classification and incidence. South Med J. 1975;68(11):1359–1365. doi:10.1097/00007611-197511000-00009
  • Guidance for industry: drug-induced liver injury: premarketing clinical evaluation; 2009. Available from: https://www.fda.gov/media/116737/download. Accessed September 30, 2021.
  • Gubelin Harcha W, Barboza Martinez J, Tsai TF, et al. A randomized, active- and placebo-controlled study of the efficacy and safety of different doses of dutasteride versus placebo and finasteride in the treatment of male subjects with androgenetic alopecia. J Am Acad Dermatol. 2014;70(3):489–498.e483. doi:10.1016/j.jaad.2013.10.049
  • Olsen EA, Hordinsky M, Whiting D, et al. The importance of dual 5α-reductase inhibition in the treatment of male pattern hair loss: results of a randomized placebo-controlled study of dutasteride versus finasteride. J Am Acad Dermatol. 2006;55(6):1014–1023. doi:10.1016/j.jaad.2006.05.007
  • Mella JM, Perret MC, Manzotti M, Catalano HN, Guyatt G. Efficacy and safety of finasteride therapy for androgenetic alopecia: a systematic review. Arch Dermatol. 2010;146(10):1141–1150. doi:10.1001/archdermatol.2010.256
  • Sidharta PN, Diamant Z, Dingemanse J. Single- and multiple-dose tolerability and pharmacokinetics of the CRTH2 antagonist setipiprant in healthy male subjects. Fundam Clin Pharmacol. 2014;28(6):690–699. doi:10.1111/fcp.12079