Novel Polymeric Lotion Formulation of Once-Daily Tazarotene (0.045%) for Moderate-to-Severe Acne: Pooled Phase 3 Analysis

March 2020 | Volume 19 | Issue 3 | Original Article | 272 | Copyright © March 2020


Published online March 1, 2020

Emil A. Tanghetti , William Philip Werschler , Edward Lain , Eric Guenin , Susan Harris , Anya Loncaric , Radhakrishnan Pillai

aCenter for Dermatology and Laser Surgery, Sacramento, CA bUniversity of Washington, School of Medicine, Seattle, WA cAustin Institute for Clinical Research, Austin, TX dOrtho Dermatologics, Bridgewater, NJ eBausch Health US, LLC, Petaluma, CA

REFERENCES

1. Leyden J, Stein-Gold L, Weiss J. Why topical retinoids are mainstay of therapy for acne. Dermatol Ther (Heidelb). 2017;7(3):293-304. 2. Tanghetti EA, Stein Gold L, Del Rosso JQ, et al. Optimized formulation for topical application of a fixed combination halobetasol/tazarotene lotion using polymeric emulsion technology. J Dermatolog Treat. 2019:1-8.
3. Draelos ZD, Tanghetti EA, Tazarotene Combination Leads to Efficacious Acne Results Trial Study G. Optimizing the use of tazarotene for the treatment of facial acne vulgaris through combination therapy. Cutis. 2002;69(2 Suppl): 20-29.
4. Leyden J, Lowe N, Kakita L, Draelos Z. Comparison of treatment of acne vulgaris with alternate-day applications of tazarotene 0.1% gel and oncedaily applications of adapalene 0.1% gel: a randomized trial. Cutis. 2001;67(6 Suppl):10-16.
5. Leyden J, Thiboutot DM, Shalita AR, et al. Comparison of tazarotene and minocycline maintenance therapies in acne vulgaris: a multicenter, doubleblind, randomized, parallel-group study. Arch Dermatol. 2006;142(5):605-612.
6. Leyden JJ, Shalita A, Thiboutot D, et al. Topical retinoids in inflammatory acne: a retrospective, investigator-blinded, vehicle-controlled, photographic assessment. Clin Ther. 2005;27(2):216-224.
7. Leyden JJ, Tanghetti EA, Miller B, et al. Once-daily tazarotene 0.1 % gel versus once-daily tretinoin 0.1 % microsponge gel for the treatment of facial acne vulgaris: a double-blind randomized trial. Cutis. 2002;69(2 Suppl):12-19.
8. Shalita A, Miller B, Menter A, et al. Tazarotene cream versus adapalene cream in the treatment of facial acne vulgaris: a multicenter, double-blind, randomized, parallel-group study. J Drugs Dermatol. 2005;4(2):153-158.
9. Shalita AR, Berson DS, Thiboutot DM, et al. Effects of tazarotene 0.1 % cream in the treatment of facial acne vulgaris: pooled results from two multicenter, double-blind, randomized, vehicle-controlled, parallel-group trials. Clin Ther. 2004;26(11):1865-1873.
10. Tanghetti E, Abramovits W, Solomon B, et al. Tazarotene versus tazarotene plus clindamycin/benzoyl peroxide in the treatment of acne vulgaris: a multicenter, double-blind, randomized parallel-group trial. J Drugs Dermatol. 2006;5(3):256-261.
11. Tanghetti E, Dhawan S, Green L, et al. Randomized comparison of the safety and efficacy of tazarotene 0.1% cream and adapalene 0.3% gel in the treatment of patients with at least moderate facial acne vulgaris. J Drugs Dermatol. 2010;9(5):549-558.
12. Tanghetti E, Dhawan S, Green L, et al. Clinical evidence for the role of a topical anti-inflammatory agent in comedonal acne: findings from a randomized study of dapsone gel 5% in combination with tazarotene cream 0.1% in patients with acne vulgaris. J Drugs Dermatol. 2011;10(7):783-792.
13. Thiboutot D, Arsonnaud S, Soto P. Efficacy and tolerability of adapalene 0.3% gel compared to tazarotene 0.1% gel in the treatment of acne vulgaris. J Drugs Dermatol. 2008;7(6 Suppl):s3-10.
14. Webster GF, Berson D, Stein LF, et al. Efficacy and tolerability of once-daily tazarotene 0.1% gel versus once-daily tretinoin 0.025% gel in the treatment of facial acne vulgaris: a randomized trial. Cutis. 2001;67(6 Suppl):4-9.
15. Webster GF, Guenther L, Poulin YP, et al. A multicenter, double-blind, randomized comparison study of the efficacy and tolerability of once-daily tazarotene 0.1% gel and adapalene 0.1% gel for the treatment of facial acne vulgaris. Cutis. 2002;69(2 Suppl):4-11.
16. Thielitz A, Abdel-Naser MB, Fluhr JW, et al. Topical retinoids in acne--an evidence- based overview. J Dtsch Dermatol Ges. 2008;6(12):1023-1031.
17. Del Rosso JQ, Tanghetti E. A status report on topical tazarotene in the management of acne vulgaris. J Drugs Dermatol. 2013;12(3):s53-58.
18. Tanghetti E, Draelos Z, Grimes P, et al. Moisturizer use enhances facial tolerability of tazarotene 0.1% cream without compromising efficacy in patients with acne vulgaris. Poster Presented at the 32nd Hawaii Dermatology Seminar. 2008.
19. Devaux S, Castela A, Archier E, et al. Adherence to topical treatment in psoriasis: a systematic literature review. J Eur Acad Dermatol Venereol. 2012;26 Suppl 3:61-67.
20. Tan X, Feldman SR, Chang J, Balkrishnan R. Topical drug delivery systems in dermatology: a review of patient adherence issues. Expert Opin Drug Deliv. 2012;9(10):1263-1271.
21. Tanghetti EA, Kircik LH, Green LJ, et al. A phase 2, multicenter, double-blind, randomized, vehicle-controlled clinical study to compare the safety and efficacy of a novel tazarotene 0.045% lotion and tazarotene 0.1% cream in the treatment of moderate-to-severe acne vulgaris. J Drugs Dermatol. 2019;18(6):542.
22. Tanghetti EA WW, Lain T, Guenin E, Martin G, Pillai R. Tazarotene 0.045% lotion for once-daily treatment of moderate-to-severe acne vulgaris: Results from two phase 3 trials. J Drugs Dermatol. 2020;19(1):70-77.
23. Eichenfield LF, Krakowski AC, Piggott C, et al. Evidence-based recommendations for the diagnosis and treatment of pediatric acne. Pediatrics. 2013;131 Suppl 3:S163-186.
24. Thiboutot D, Gollnick H, Bettoli V, et al. New insights into the management of acne: an update from the Global Alliance to Improve Outcomes in Acne group. J Am Acad Dermatol. 2009;60(5 Suppl):S1-50.
25. Hoffman LK, Bhatia N, Zeichner J, Kircik LH. Topical vehicle formulations in the treatment of acne. J Drugs Dermatol. 2018;17(6):s6-s10.
26. Del Rosso JQ, Kircik LH, Zeichner J, Stein Gold L. The clinical relevance and therapeutic benefit of established active ingredients incorporated into advanced foam vehicles: Vehicle characteristics can influence and improve patient outcomes. J Drugs Dermatol. 2019;18(2s):s100-s107.
27. Del Rosso JQ, Kircik L, Lin T, Pillai R. Halobetasol 0.01%/tazarotene 0.045% fixed-combination lotion in the treatment of plaque psoriasis: Sensitization and irritation potential. J Clin Aesthet Dermatol. 2019;12(1):11-15.
28. Zhao Y, Jones SA, Brown MB. Dynamic foams in topical drug delivery. J Pharm Pharmacol. 2010;62(6):678-684.
29. Feldman SR, Werner CP, Alio Saenz AB. The efficacy and tolerability of tazarotene foam, 0.1%, in the treatment of acne vulgaris in 2 multicenter, randomized, vehicle-controlled, double-blind studies. J Drugs Dermatol. 2013;12(4):438-446.

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