Expert dialogue on topical minocycline gel in acne vulgaris: minologue India
DOI:
https://doi.org/10.18203/issn.2455-4529.IntJResDermatol20240685Keywords:
Topical, Minocycline, Acne, Recommendations, ConsensusAbstract
Acne vulgaris is a common skin disorder with a global prevalence of about 9.4%. Oral antibacterials are recommended but they are associated with potential systemic side effects. Topical minocycline 4% has been recently approved by the United States Food and Drug Administration (US-FDA) for the management of moderate to severe acne. Although efficacy and safety are established, little is known of its real word usage. To review and appraise existing literature and make recommendations on the real world usage and positioning of topical minocycline 4% in acne management. The minocycline 4% consensus was developed by nine acne experts and was evidence-based on a review of recent topical minocycline 4% literature. A total of 11 questions were discussed regarding different domains like positioning of topical minocycline in acne management as monotherapy and combination therapy, safety and use in special population. Several recommendations were given regarding topical minocycline use like: no monotherapy use; consider use in combination with other anti-acne treatments like isotretinoin, adapalene and benzoyl peroxide; not recommended to be combined with systemic antibiotics; low chances for hyperpigmentation; use of sun protection measures; consider risk benefit ratio in pregnancy; use in lactation not recommended; and can be used only in children >9 years of age. This consensus has discussed and answered many real world usage questions and place in therapy for topical minocycline in acne management and finds it a useful addition to the existing armamentarium.
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References
Heng AH, Chew FT. Systematic review of the epidemiology of acne vulgaris. Scientific Rep. 2020;10(1):1-29.
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. The Lancet. 2012;380(9859):2163-96.
Dréno B, Pécastaings S, Corvec S, Veraldi S, Khammari A, Roques C. Cutibacterium acnes (Propionibacterium acnes) and acne vulgaris: a brief look at the latest updates. J Eur Acad Dermatol Venereol. 2018;32(2):5-14.
Zaenglein AL, Pathy AL, Schlosser BJ, Alikhan A, Baldwin HE, Berson DS, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016;74(5):945-73.
Bienenfeld A, Nagler AR, Orlow SJ. Oral antibacterial therapy for acne vulgaris: an evidence-based review. Am J Clin Dermatol. 2017;18(4):469-90.
Xu H, Li H. Acne, the skin microbiome, and antibiotic treatment. Am J Clin Dermatol. 2019;20(3):335-44.
Biswal I, Gaind R, Kumar N, Mohanty S, Manchanda V, Khunger N, et al. In vitro antimicrobial susceptibility patterns of Propionibacterium acnes isolated from patients with acne vulgaris. J Infect Dev Ctries. 2016;10(10):1140–5.
AMZEEQ prescribing information. Mohlin, Switzerland, MA: Foamix Pharmaceuticals Inc. 2018. Available at: https://www.accessdata.fda.gov /drugsatfda_docs/label/2019/212379s000lbl.pdf. Accessed on 26 February 2023.
Recommendations of the SEC (Dermatology & Allergy) at 54th meeting. 2021. CDSCO HQ New Delhi. Available at: https://cdsco.gov.in/opencms /resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/54th%20%20Dermatology%20Recommendation%2012.01.2021.pdf. Accessed on 26 February 2023.
Fefer JP, Stone SD, Daigle J, Silka L. Using the Delphi technique to identify key elements for effective and sustainable visitor use planning frameworks. Sage Open. 2016;6(2):1-16.
Leyden JJ, Hickman JG, Jarratt MT, Stewart DM, Levy SF. The efficacy and safety of a combination benzoyl peroxide/clindamycin topical gel compared with benzoyl peroxide alone and a benzoyl peroxide/erythromycin combination product. J Cutan Med Surg. 2001;5:3742.
Lookingbill DP, Chalker DK, Lindholm JS, Katz HI, Kempers SE, Huerter CJ, et al. Treatment of acne with a combination clindamycin/benzoyl peroxide gel compared with clindamycin gel, benzoyl peroxide gel and vehicle gel: combined results of two double-blind investigations. J Am Acad Dermatol. 1997;37:590-5.
Tschen EH, Katz HI, Jones TM, Monroe EW, Kraus SJ, Connolly MA, et al. A combination benzoyl peroxide and clindamycin topical gel compared with benzoyl peroxide, clindamycin phosphate, and vehicle in the treatment of acne vulgaris. Cutis. 2001;67:165-9.
Thiboutot DM, Dréno B, Abanmi A, Alexis AF, Araviiskaia E, Barona Cabal MI, 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.
Titus S, Hodge J. Diagnosis and treatment of acne. Am Fam Physician. 2012;86(8):734-40.
Rigopoulos D, Larios G, Katsambas AD. The role of isotretinoin in acne therapy: why not as first-line therapy? facts and controversies. Clin Dermatol. 2010;28(1):24-30.
Layton AM, Knaggs H, Taylor J, Cunliffe WJ. Isotretinoin for acne vulgaris - 10 years later: A safe and successful treatment. Br J Dermatol. 1993;129:292-6.
ACCUTANE (isotretinoin capsule). Roche Pharmaceuticals Inc. 2008. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018662s059lbl.pdf. Accessed on 26 February 2023.
Friedman DI. Medication-induced intracranial hypertension in dermatology. Am J Clin Dermatol. 2005;6(1):29-37.
Lee AG. Pseudotumor cerebri after treatment with tetracycline and isotretinoin for acne. Cutis. 1995;55:165-8.
Spector RH, Carlisle J. Pseudotumor cerebri caused by a synthetic vitamin A preparation. Neurology. 1984;34:1509-11.
MINOCIN (Minocycline hydrochloride pellet-filled capsules). USA: Patheon Pharmaceuticals Inc. 2017. Available at: https://dailymed.nlm.nih.gov/daily med/fda/fdaDrugXsl.cfm?setid=6dd5b14b-ebfc-49a2-ac63-429f9a8b974f&type=display. Accessed on 26 February 2023.
Moskowitz T, Leibowitz E, Ronen M, Aviel E. Pseudotumor cerebri induced by vitamin A combined with minocycline. Ann Ophthalmol. 1993;25:306-8.
Tintle SJ, Harper JC, Webster GF, Kim GK, Thiboutot DM. Safe Use of Therapeutic-Dose Oral Isotretinoin in Patients with a History of Pseudotumor Cerebri. JAMA Dermatol. 2016;152(5):582-4.
Reserva J, Adams W, Perlman D, Vasicek B, Joyce C, Tung R, et al. Coprescription of Isotretinoin and Tetracyclines for Acne is Rare: An Analysis of the National Ambulatory Medical Care Survey. J Clin Aesthet Dermatol. 2019;12(10):45-8.
Jones TM, Ellman H. Pharmacokinetic comparison of once-daily topical minocycline foam 4% vs oral minocycline for moderate-to-severe acne. J Drug Dermatol. 2017;16(10):1022-8.
Stein Gold L, Dhawan S, Weiss J, Draelos ZD, Ellman H, Stuart I. Open-label extension study evaluating long-term safety and efficacy of FMX101 4% minocycline foam for moderate-to-severe acne vulgaris. J Clin Aesthet Dermatol. 2019;12(10):16-23.
Lain E. A Companion Treatment Study for Patients With Moderate to Severe Acne Vulgaris. Unpublished. Available at: https://clinicaltrials. gov/ct2/show/NCT04940767?term=isotretinoin&cond=Acne+Vulgaris&cntry=US&draw=2&rank=2. Accessed on 26 February 2023.
ICTRP Search Portal. trialsearch.who.int. Available at: https://trialsearch.who.int/Trial2.aspx?TrialID= CTRI/2023/04/052056. Accessed on 26 February 2023.
Pariser DM, Rich P, Cook-Bolden FE, Korotzer A. An aqueous gel fixed combination of clindamycin phosphate 1.2% and benzoyl peroxide 3.75% for the once-daily treatment of moderate to severe acne vulgaris. J Drugs Dermatol. 2014;13:1083-9.
Wolf JE Jr, Kaplan D, Kraus SJ, Loven KH, Rist T, Swinyer LJ, et al. Efficacy and tolerability of combined topical treatment of acne vulgaris with adapalene and clindamycin: a multicenter, randomized, investigator-blinded study. J Am Acad Dermatol. 2003;49:S211-7.
Cunliffe WJ, Meynadier J, Alirezai M, George SA, Coutts I, Roseeuw DI, et al. Is combined oral and topical therapy better than oral therapy alone in patients with moderate to moderately severe acne vulgaris? A comparison of the efficacy and safety of lymecycline plus adapalene gel 0.1%, versus lymecycline plus gel vehicle. J Am Acad Dermatol. 2003;49(3):S218-26.
Thiboutot DM, Shalita AR, Yamauchi PS, Dawson C, Arsonnaud S, Kang S; Differin Study Group. Combination therapy with adapalene gel 0.1% and doxycycline for severe acne vulgaris: a multicenter, investigator-blind, randomized, controlled study. Skinmed. 2005;4(3):138-46.
Mendoza N, Hernandez PO, Tyring SK, Haitz KA, Motta A. Antimicrobial susceptibility of Propionibacterium acnes isolates from acne patients in Colombia. Int J Dermatol. 2013;52(6):688-92.
Zhu T, Zhu W, Wang Q, He L, Wu W, Liu J, et al. Antibiotic susceptibility of Propionibacterium acnes isolated from patients with acne in a public hospital in Southwest China: prospective cross-sectional study. BMJ Open. 2019;9:e022938.
Sutcliffe J, McLaughlin R, Webster G, Read AF, Drlica K, Elliott R, Stuart I. Susceptibility of Cutibacterium acnes to topical minocycline foam. Anaerobe. 2020;62:102169.
Del Rosso JQ, Gold LS, Draelos Z, Raoof TJ, Hooper D, Stuart I. A Prospective, Multicenter, Randomized, Double-blind, Vehicle-controlled Phase 2 Study to Evaluate the Safety and Efficacy of a Combination Of 3% Minocycline and 0.3% Adapalene Topical Foam Formulation for the Treatment of Moderate-to-Severe Acne. SKIN J Cutaneous Med. 2020;4(6):s90.
Dosik J, Ellman H, Stuart I. Topical minocycline foam 4%: results of four phase 1 studies evaluating the potential for phototoxicity, photoallergy, sensitization, and cumulative irritation. J Immunotoxicol. 2019;16(1):133-9.
Stein Gold L, Dhawan S, Weiss J, Draelos ZD, Ellman H, Stuart IA. A novel topical minocycline foam for the treatment of moderate-to-severe acne vulgaris: results of 2 randomized, double-blind, phase 3 studies. J Am Acad Dermatol. 2019;80(1):168-77.
Raoof TJ, Hooper D, Moore A, Zaiac M, Sullivan T, Kircik L, et al. Efficacy and safety of a novel topical minocycline foam for the treatment of moderate to severe acne vulgaris: a phase 3 study. J Am Acad Dermatol. 2020;82(4):832-7.
Martins AM, Marto JM, Johnson JL, Graber EM. A Review of Systemic Minocycline Side Effects and Topical Minocycline as a Safer Alternative for Treating Acne and Rosacea. Antibiotics (Basel). 2021;10(7):757.
Drugs.com. Minocycline (Topical). Available at: https://www.drugs.com/monograph/minocycline-topical.html. Accessed on 26 February 2023.
Webster G, Draelos ZD, Graber E, Lee MS, Dhawan S, Salman M, et al. A multicentre, randomized, double-masked, parallel group, vehicle-controlled phase IIb study to evaluate the safety and efficacy of 1% and 3% topical minocycline gel in patients with papulopustular rosacea. Br J Dermatol. 2020;183(3):471-9.
Ochsendorf F. Minocycline in acne vulgaris: benefits and risks. Am J Clin Dermatol. 2010;11(5):327-41.
Eisen D, Hakim MD. Minocycline-induced pigmentation. Incidence, prevention and management. Drug Saf. 1998;18(6):431-40.
Dereure O. Drug-induced skin pigmentation. Am J Clin Dermatol. 2001;2(4):25362.
Taveres J, Leung W. Discoloration of nail beds and skin from minocycline. Can Med Assoc J. 2011;183(2):224.
Abad-Casintahan F, Chow SK, Goh CL, Kubba R, Hayashi N, Noppakun N, et al. Frequency and characteristics of acne-related post-inflammatory hyperpigmentation. J Dermatol. 2016;43(7):826-8.
Al-Qarqaz F, Bodoor K, Baba A, Al-Yousef A, Muhaidat J, Alshiyab D. Post-acne hyperpigmentation: Evaluation of risk factors and the use of artificial neural network as a predictive classifier. Dermatol Rep. 2021;13(3):8223.
Hazot Y, Malinov T, Gazal E, Keynan R, Margulis L, Tamarkin D. Topical oleaginous minocycline foam: efficacious delivery into skin layers. J Anal Pharm Res. 2017;4(5):1-5.
Frost P, Weinstein GD, Gomez EC. Phototoxic Potential of Minocycline and Doxycycline. Arch Dermatol. 1972;105(5):681-3.
Paik J. Topical Minocycline Foam 4%: A Review in Acne Vulgaris. Am J Clin Dermatol. 2020;21(3):449-56.
Shah B, Mistry D, Gonsalves N, Vasani P, Dhoot D, Barkate H. A Prospective, Randomized, Comparative Study of Topical Minocycline Gel 4% with Topical Clindamycin Phosphate Gel 1% in Indian Patients with Acne Vulgaris. Antibiotics. 2023;12(9):1455.
Search Drug Information. CIMS. Available at: https://www.mims.com/india/drug. Accessed on 26 February 2023.