La Roche Posay, Lipidor AB, L’Oreal, Ortho Dermatologics, Sebacia, SolGel, Verrica, and WebMD. Dr Harper reported receiving honoraria for serving as a consultant, speaker, and/or investigator for Almirall, Cassiopeia, Cutera, EPI, Galderma, Journey, L’oreal, Ortho, Sol Gel, Sun, and Vyne and received honoraria for holding stocks in Cutera. Dr Alexis reported receiving grants and/or royalties from Abbvie, Almirall SA, Amgen, Arcutis, Bristol-Myers-Squibb, Cara, Castle, Dermavant, Galderma, Leo, Novartis, Springer, Wiley-Blackwell, Wolters Kluwer Health, Valeant (Bausch Health), and Vyne; and served as a consultant/advisor and/or speaker for Abbvie, Allergan, Almirall SA, Amgen, Arcutis, Bausch health, Beiersdorf, BMS, Cara, Castle, Cutera, Dermavant, Eli Lilly, EPI, Galderma, Incyte, Janssen, Leo, L’Oreal, Ortho, Pfizer, Sanofi-Genzyme, Sanofi-Regeneron, Swiss American, Regeneron, UCB, VisualDx, and Vyne. Dr Stein Gold served as an investigator, advisor and/or speaker for Almirall SA, Galderma, Ortho Derm, and Sun. Dr Kircik served as an investigator, speaker, advisory board member, and/or consultant for Abbott Laboratories, Aclaris, Inc, Allergan, Inc, Almirall, Anacor Pharmaceuticals, Inc, Assos Pharma, Astellas Pharma US, Inc, Asubio Pharma Co, Ltd, Berlex Laboratories (Bayer Healthcare Pharmaceuticals), Biogen-Idec, Inc, Biolife, Biopelle, Boehringer Ingelheim, Breckinridge Pharma, Celgene Corporation, Centocor, Inc, Colbar, CollaGenex, Combinatrix, Connetics Corporation, Coria, Dermik Laboratories, Dermira, Inc, Dow Pharmaceutical Sciences, Inc, Dusa Pharmaceuticals, Inc, Eli Lilly & Co, Embil Pharmaceutical Co, Ltd, EOS, Ferndale Laboratories, Inc, Galderma Laboratories, LP, Genentech, Inc, GlaxoSmithKline, PLC, Health Point Ltd, Idera, Inc, Innocutis Medical, LLC, Innovail, Intendis, Inc, Johnson & Johnson, Laboratory Skin Care, Inc, Leo Pharmaceuticals, Inc, L’Oreal SA, 3M, Maruho Co, Ltd, Medical International Technologies, Medicis Pharmaceutical Corp, Merck & Co, Inc, Merz, Nano Bio Corporation, Novartis Pharmaceutical Corporation, Noven Pharmaceuticals, Inc, Nucryst Pharmaceuticals Corporation, Obagi Medical Products, Inc, Onset, Ortho Dermatologics, Ortho Neutrogena, PediaPharma, Inc, Promius Pharma, LLC, PharmaDerm, Pfizer, Inc, PuraCap, QLT, Inc, Quatrix, Quinnova, Serono (Merck-Serono International SA), SkinMedica, Inc, Stiefel Laboratories, Inc, Sun Pharmaceutical Industries, Ltd, Taro, TolerRx, Inc, Triax, UCB, Inc, Valeant Pharmaceuticals North America LLC, Warner-Chilcott, XenoPort, Inc, and ZAGE. Dr. Del Rosso served as a research investigator, consultant/advisor, and/or speaker for AbbVie, Aclaris, Almirall, Amgen (Celgene), AnaptysBio, Arcutis, Athenex, Bausch (Ortho Dermatologics), Biofrontera, BioPharmX, Biorasi, Blue Creek, Botanix, Brickell, Bristol Myers Squibb, Cara Therapeutics, Cassiopea, Dermata, Dermavant, Encore, EPI Health, Ferndale, Galderma, Genentech, Incyte, Jem Health, LEO Pharma, La Roche-Posay, Lilly (Dermira), MC2, NOVAN, Pfizer, Ralexar, Regeneron, Sanofi-Genzyme, Sente, Solgel, Sonoma (Intraderm), Sun Pharma, UCB, Verrica, and VYNE (Foamix/Menlo). Dr Hebert reported receiving grants and/or honoraria from Almirall SA, Amryt, Arcutis, Dermavant, GSK, Incyte, Leo, Lilly, Novan, Pfizer, and Sun Pharma; and served as a member of Data and Safety Monitoring Board for GSK, Ortho Dermatologics, and Regeneron-Sanofi. Dr Fried served as a research investigator and/or scientific advisor for AbbVie, BI, BMS, Dermavant, Dermira, EPI, Incyte, Janssen, LEO, Lilly, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi Sun, and UCB. Dr. Siva Narayanan reported receiving consulting honoraria or research funding from Almirall, Biogen, Johnson and Johnson, Sarepta Therapeutics, SeaGen, and Takeda. Dr Koscielny and Dr Kasujee are employees of Almirall, SA. Dr Hilary E. Baldwin has served as an advisor, speaker, consultant and/or investigator for: Almirall, Arcutis, Bausch, Cutera, EPI, Galderma, Journey, La Roche-Posay, L’Oreal, Novan, Sol-Gel, and SUN.
ACKNOWLEDGMENT
Funding for this study was provided by Almirall S.A. We thank Phase to Phase Strategy, LLC for medical writing services.
REFERENCES
- Vos T, Flaxman AD, Naghavi 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(9859):2163-96. doi:10.1016/S0140-6736(12)61729-2
- Tan JK, Bhate K. A global perspective on the epidemiology of acne. Br J Dermatol. Jul 2015;172 Suppl 1:3-12. doi:10.1111/bjd.13462
- Layton AM, Thiboutot D, Tan J. Reviewing the global burden of acne: how could we improve care to reduce the burden? Br J Dermatol. 2021;184(2):219-225. doi:10.1111/bjd.19477
- Bhate K, Williams HC. Epidemiology of acne vulgaris. Br J Dermatol. 2013;168(3):474-85. doi:10.1111/bjd.12149
- Goulden V, Stables GI, Cunliffe WJ. Prevalence of facial acne in adults. J Am Acad Dermatol. 1999;41(4):577-80.
- Acne clinical guideline. American Academy of Dermatology. Accessed December 16, 2022. https://www.aad. org/member/clinical-quality/guidelines/acne
- Gieler U, Gieler T, Kupfer JP. Acne and quality of life - impact and management. J Eur Acad Dermatol Venereol. 2015;29 Suppl 4:12-4. doi:10.1111/jdv.13191
- Timms RM. Moderate acne as a potential barrier to social relationships: myth or reality? Psychol Health Med. 2013;18(3):310-20. doi:10.1080/13548506.2012.726363
- Revol O, Milliez N, Gerard D. Psychological impact of acne on 21st-century adolescents: decoding for better care. Br J Dermatol. 2015;172(Suppl 1):52-8. doi:10.1111/bjd.13749
- Lindberg M, Isacson D, Bingefors K. Self-reported skin diseases, quality of life and medication use: a nationwide pharmaco-epidemiological survey in Sweden. Acta Derm Venereol. 2014;94(2):188-91. doi:10.2340/00015555- 1672
- Cresce ND, Davis SA, Huang WW, et al. The quality of life impact of acne and rosacea compared to other major medical conditions. J Drugs Dermatol. 2014;13(6):692-7.
- Mallon E, Newton JN, Klassen A, et al. The quality of life in acne: a comparison with general medical conditions using generic questionnaires. Br J Dermatol. 1999;140(4):672-6. doi:10.1046/j.1365-2133.1999.02768.x
- Zaenglein AL, Pathy AL, Schlosser BJ, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016;74(5):945-73 e33. doi:10.1016/j.jaad.2015.12.037
- Thiboutot DM, Dreno 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 Suppl 1):S1-S23 e1. doi:10.1016/j.jaad.2017.09.078
- Leyden JJ, Sniukiene V, Berk DR, et al. Efficacy and Safety of Sarecycline, a Novel, Once-Daily, Narrow Spectrum Antibiotic for the Treatment of Moderate to Severe Facial Acne Vulgaris: Results of a Phase 2, Dose- Ranging Study. J Drugs Dermatol. 2018;17(3):333-338.
- Armstrong AW, Hekmatjah J, Kircik LH. Oral Tetracyclines and Acne: A Systematic Review for Dermatologists. J Drugs Dermatol. 2020;19(11):s6-s13.
- Bienenfeld A, Nagler AR, Orlow SJ. Oral antibacterial therapy for acne vulgaris: an evidence-based review. Am J Clin Dermatol. 2017;18(4):469-490. doi:10.1007/s40257-017-0267-z
- Ghannoum MA, Long L, Bunick CG, et al. Sarecycline demonstrated reduced activity compared to minocycline against microbial species representing human gastrointestinal microbiota. Antibiotics (Basel). 2022;11(3) doi:10.3390/antibiotics11030324
- Leyden JJ, McGinley KJ, Cavalieri S, et al. Propionibacterium acnes resistance to antibiotics in acne patients. J Am Acad Dermatol. 1983;8(1):41-5. doi:10.1016/s0190-9622(83)70005-8
- Moore A, Green LJ, Bruce S, et al. Once-daily oral sarecycline 1.5 mg/kg/day is effective for moderate to severe acne vulgaris: results from two identically designed, phase 3, randomized, double-blind clinical trials. J Drugs Dermatol. 2018;17(9):987-996.
- SEYSARA (sarecycline) tablets for oral use. Almirall LLC.
- Zhanel G, Critchley I, Lin LY, et al. Microbiological profile of sarecycline, a novel targeted spectrum tetracycline for the treatment of acne vulgaris. Antimicrob Agents Chemother. 2019;63(1)doi:10.1128/AAC.01297-18
- Drugs@FDA: FDA-Approved Drugs. US Food and Drug Administration. Accessed 8 September, 2022.https:// www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&var ApplNo=209521
- Layton AM, Eady EA, Thiboutot DM, et al. Identifying what to measure in acne clinical trials: first steps towards development of a core outcome set. J Invest Dermatol. Aug 2017;137(8):1784-1786. doi:10.1016/j.jid.2017.04.017
- Chernyshov PV, Zouboulis CC, Tomas-Aragones L, et al. Quality of life measurement in acne. Position paper of the European Academy of Dermatology and Venereology Task Forces on Quality of Life and Patient Oriented Outcomes and Acne, Rosacea and Hidradenitis Suppurativa. J Eur Acad Dermatol Venereol. 2018;32(2):194-208. doi:10.1111/jdv.14585
- Hornsey S, Stuart B, Muller I, et al. Patient-reported outcome measures for acne: a mixed-methods validation study (acne PROMs). BMJ Open. 2021;11(3):e034047. doi:10.1136/bmjopen-2019-034047
- Williams HC, Dellavalle RP, Garner S. Acne vulgaris. Lancet. 2012;379(9813):361-72. doi:10.1016/S0140- 6736(11)60321-8
- Barratt H, Hamilton F, Car J, et al. Outcome measures in acne vulgaris: systematic review. Br J Dermatol. 2009;160(1):132-6. doi:10.1111/j.1365-2133.2008.08819.x
- Alexis A, Daniels SR, Johnson N, et al. Development of a new patient-reported outcome measure for facial acne: the Acne Symptom and Impact Scale (ASIS). J Drugs Dermatol. 2014;13(3):333-40.
- Hudgens S, Harper JC, Daniels SR, et al. Validation of a new patient-reported outcome measure for facial acne: The Acne Symptom and Impact Scale (ASIS). J Drugs Dermatol. 2015;14(6):552-9.
- Altunay IK, Ozkur E, Dalgard FJ, et al. Psychosocial aspects of adult acne: data from 13 European countries. Acta Derm Venereol. 2020;100(4):adv00051. doi:10.2340/00015555-3409
- Ahmed SH, El-Kelish AA, Hafeez NA, et al. Influential factors of depression in patients with moderate and severe acne. J Clin Aesthet Dermatol. 2020;13(2):13-16.
- Xu S, Zhu Y, Hu H, et al. The analysis of acne increasing suicide risk. Medicine (Baltimore). 2021;100(24):e26035. doi:10.1097/MD.0000000000026035
- Lukaviciute L, Ganceviciene R, Navickas P, et al. Anxiety, depression, and suicidal ideation amongst patients with facial dermatoses (acne, rosacea, perioral dermatitis, and folliculitis) in Lithuania. Dermatology. 2020;236(4):314-322. doi:10.1159/000506627
- Lukaviciute L, Navickas P, Navickas A, et al. Quality of life, anxiety prevalence, depression symptomatology and suicidal ideation among acne patients in Lithuania. J Eur Acad Dermatol Venereol. 2017;31(11):1900-1906. doi:10.1111/jdv.14477
- Sackett DL, Rosenberg WM, Gray JA, et al. Evidence based medicine: what it is and what it isn't. BMJ. 1996;312(7023):71-2. doi:10.1136/bmj.312.7023.71
- Klassen AF, Cano SJ, Scott A, et al. Measuring patient-reported outcomes in facial aesthetic patients: development of the FACE-Q. Facial Plast Surg. 2010;26(4):303-9. doi:10.1055/s-0030-1262313
AUTHOR CORRESPONDENCE
Hilary E. Baldwin MD HBaldwin@acnetrc.com