identical phase 3 trials, regardless of race and ethnicity, with
fewer acne lesions and improved treatment success over a 12-
week course of therapy. This new formulation of tazarotene had
good tolerability compared with vehicle lotion as well as lower
rates of irritation-related TEAEs compared with retinoid-based
treatments. Tazarotene 0.045% lotion does not appear to induce
post-inflammatory hyperpigmentation and may be an effective
and well tolerated treatment option for patients with skin of
color.
DISCLOSURES
Neal Bhatia has received honoraria and investigator grants
from Bausch Health. Jonathan S. Weiss is a consultant, speaker,
advisor, and/or researcher for Abbvie, Ortho Dermatologics/
Bausch Health US, Galderma, Foamix, Promius/Dr. Reddy’s,
LEO Pharma, Novartis, Sanofi/Regeneron, Aclaris, Endo International,
Dermira, and Almirall. Neil Sadick has served on
advisory boards, as a consultant, investigator, speaker, and/or
other and has received honoraria and/or grants/research funding
from Almirall, Actavis, Allergan, Anacor Pharmaceuticals,
Auxilium Pharmaceuticals, Bausch Health, Bayer, Biorasi, BTG,
Carma Laboratories, Cassiopea, Celgene Corporation, Cutera,
Cynosure, DUSA Pharmaceuticals, Eclipse Medical, Eli Lilly and
Company, Endo International, EndyMed Medical, Ferndale Laboratories,
Galderma, Gerson Lehrman Group, Hydropeptide,
Merz Aesthetics, Neostrata, Novartis, Nutraceutical Wellness,
Palomar Medical Technologies, Prescriber's Choice, Regeneron,
Roche Laboratories, Samumed, Solta Medical, Storz Medical
AG, Suneva Medical, Vanda Pharmaceuticals, and Venus Concept.
Fran E. Cook-Bolden has served as consultant, speaker,
investigator for Galderma, LEO Pharma, Almirall, Cassiopea,
Ortho Dermatologics, Investigators Encore, Foamix, Hovione,
Aclaris, and Cutanea. Stephen K. Tyring has acted as an investigator
for Ortho Dermatologics. Eric Guenin is an employee of
Ortho Dermatologics and may hold stock and/or stock options
in its parent company. Anya Loncaric and Susan Harris are employees
of Bausch Health US, LLC and may hold stock and/or
stock options in its parent company. Bausch Health US, LLC is an
affiliate of Bausch Health Companies Inc. Ortho Dermatologics
is a division of Bausch Health US, LLC.
ACKNOWLEDGMENTS
Medical writing and editorial support were provided by Prescott
Medical Communications Group (Chicago, IL) with financial
support from Ortho Dermatologics. Ortho Dermatologics is a
division of Bausch Health US, LLC.
REFERENCES
1. Davis SA, Narahari S, Feldman SR, et al. Top dermatologic conditions in patients of color: an analysis of nationally representative data. J Drugs Dermatol. 2012;11(4):466-473.
2. Kundu RV, Patterson S. Dermatologic conditions in skin of color: part I. Special considerations for common skin disorders. Am Fam Physician. 2013;87(12):850-856.
3. Han G, Armstrong AW, Desai SR, Guenin E. Novel tretinoin 0.05% lotion for the once-daily treatment of moderate-to-severe acne vulgaris in an Asian population. J Drugs Dermatol. 2019;18(9):910-916.
4. Alexis AF, Cook-Bolden F, Lin T. Treatment of moderate-to-severe acne vulgaris in a hispanic population: a post-hoc analysis of the efficacy and tolerability of clindamycin 1.2%/benzoyl peroxide 3.75% gel. J Clin Aesthet Dermatol. 2017;10(6):36-43.
5. Rendon MI, Rodriguez DA, Kawata AK, et al. Acne treatment patterns, expectations, and satisfaction among adult females of different races/ethnicities. Clin Cosmet Investig Dermatol. 2015;8:231-238.
6. Lawson CN, Hollinger J, Sethi S, et al. Updates in the understanding and treatments of skin & hair disorders in women of color. Int J Womens Dermatol. 2017;3(1 Suppl):S21-S37.
7. Dreno B, Pecastaings S, Corvec S, et al. Cutibacterium acnes (Propionibacterium acnes) and acne vulgaris: a brief look at the latest updates. J Eur Acad Dermatol Venereol. 2018;32 Suppl 2:5-14.
8. Callender VD, Alexis AF, Daniels SR, et al. Racial differences in clinical characteristics, perceptions and behaviors, and psychosocial impact of adult female acne. J Clin Aesthet Dermatol. 2014;7(7):19-31.
9. Perkins AC, Cheng CE, Hillebrand GG, et al. Comparison of the epidemiology of acne vulgaris among caucasian, Asian, Continental Indian and African American women. J Eur Acad Dermatol Venereol. 2011;25(9):1054-1060.
10. Yin NC, McMichael AJ. Acne in patients with skin of color: practical management. Am J Clin Dermatol. 2014;15(1):7-16.
11. Tirado-Sanchez A, Espindola YS, Ponce-Olivera RM, Bonifaz A. Efficacy and safety of adapalene gel 0.1% and 0.3% and tretinoin gel 0.05% for acne vulgaris: results of a single-center, randomized, double-blinded, placebo-controlled clinical trial on Mexican patients (skin type III-IV). J Cosmet Dermatol. 2013;12(2):103-107.
12. Alexis AF. Acne vulgaris in skin of color: understanding nuances and optimizing treatment outcomes. J Drugs Dermatol. 2014;13(6):s61-65.
13. Leyden J, Stein-Gold L, Weiss J. Why topical retinoids are mainstay of therapy for acne. Dermatol Ther (Heidelb). 2017;7(3):293-304.
14. Hoffman LK, Bhatia N, Zeichner J, Kircik LH. Topical vehicle formulations in the treatment of acne. J Drugs Dermatol. 2018;17(6):s6-s10.
15. 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.
16. 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.
17. Tanghetti EA, Werschler WP, Lain T, et al. Tazarotene 0.045% lotion for oncedaily treatment of moderate-to-severe acne vulgaris: results from two phase 3 trials. J Drugs Dermatol. 2020;19(1):70-77.
18. DuBois J, Ong GCW, Petkar G, et al. Patient-reported outcomes in acne patients with skin of color using adapalene 0.3%-benzoyl peroxide 2.5%: a prospective real-world study. J Drugs Dermatol. 2019;18(5):514.
19. Callender VD, Preston N, Osborn C, et al. A meta-analysis to investigate the relation between fitzpatrick skin types and tolerability of adapalene-benzoyl peroxide topical gel in subjects with mild or moderate acne. J Clin Aesthet Dermatol. 2010;3(8):15-19.
20. Grimes P, Callender V. Tazarotene cream for postinflammatory hyperpigmentation and acne vulgaris in darker skin: a double-blind, randomized, vehiclecontrolled study. Cutis. 2006;77(1):45-50.
21. Charrow A, Xia FD, Joyce C, Mostaghimi A. Diversity in dermatology clinical trials: a systematic review. JAMA Dermatol. 2017;153(2):193-198.
22. He SY, McCulloch CE, Boscardin WJ, et al. Self-reported pigmentary phenotypes and race are significant but incomplete predictors of Fitzpatrick skin phototype in an ethnically diverse population. J Am Acad Dermatol. 2014;71(4):731-737.
23. Culp L, Moradi Tuchayi S, Alinia H, Feldman SR. Tolerability of topical retinoids: Are there clinically meaningful differences among topical retinoids? J Cutan Med Surg. 2015;19(6):530-538.
2. Kundu RV, Patterson S. Dermatologic conditions in skin of color: part I. Special considerations for common skin disorders. Am Fam Physician. 2013;87(12):850-856.
3. Han G, Armstrong AW, Desai SR, Guenin E. Novel tretinoin 0.05% lotion for the once-daily treatment of moderate-to-severe acne vulgaris in an Asian population. J Drugs Dermatol. 2019;18(9):910-916.
4. Alexis AF, Cook-Bolden F, Lin T. Treatment of moderate-to-severe acne vulgaris in a hispanic population: a post-hoc analysis of the efficacy and tolerability of clindamycin 1.2%/benzoyl peroxide 3.75% gel. J Clin Aesthet Dermatol. 2017;10(6):36-43.
5. Rendon MI, Rodriguez DA, Kawata AK, et al. Acne treatment patterns, expectations, and satisfaction among adult females of different races/ethnicities. Clin Cosmet Investig Dermatol. 2015;8:231-238.
6. Lawson CN, Hollinger J, Sethi S, et al. Updates in the understanding and treatments of skin & hair disorders in women of color. Int J Womens Dermatol. 2017;3(1 Suppl):S21-S37.
7. Dreno B, Pecastaings S, Corvec S, et al. Cutibacterium acnes (Propionibacterium acnes) and acne vulgaris: a brief look at the latest updates. J Eur Acad Dermatol Venereol. 2018;32 Suppl 2:5-14.
8. Callender VD, Alexis AF, Daniels SR, et al. Racial differences in clinical characteristics, perceptions and behaviors, and psychosocial impact of adult female acne. J Clin Aesthet Dermatol. 2014;7(7):19-31.
9. Perkins AC, Cheng CE, Hillebrand GG, et al. Comparison of the epidemiology of acne vulgaris among caucasian, Asian, Continental Indian and African American women. J Eur Acad Dermatol Venereol. 2011;25(9):1054-1060.
10. Yin NC, McMichael AJ. Acne in patients with skin of color: practical management. Am J Clin Dermatol. 2014;15(1):7-16.
11. Tirado-Sanchez A, Espindola YS, Ponce-Olivera RM, Bonifaz A. Efficacy and safety of adapalene gel 0.1% and 0.3% and tretinoin gel 0.05% for acne vulgaris: results of a single-center, randomized, double-blinded, placebo-controlled clinical trial on Mexican patients (skin type III-IV). J Cosmet Dermatol. 2013;12(2):103-107.
12. Alexis AF. Acne vulgaris in skin of color: understanding nuances and optimizing treatment outcomes. J Drugs Dermatol. 2014;13(6):s61-65.
13. Leyden J, Stein-Gold L, Weiss J. Why topical retinoids are mainstay of therapy for acne. Dermatol Ther (Heidelb). 2017;7(3):293-304.
14. Hoffman LK, Bhatia N, Zeichner J, Kircik LH. Topical vehicle formulations in the treatment of acne. J Drugs Dermatol. 2018;17(6):s6-s10.
15. 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.
16. 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.
17. Tanghetti EA, Werschler WP, Lain T, et al. Tazarotene 0.045% lotion for oncedaily treatment of moderate-to-severe acne vulgaris: results from two phase 3 trials. J Drugs Dermatol. 2020;19(1):70-77.
18. DuBois J, Ong GCW, Petkar G, et al. Patient-reported outcomes in acne patients with skin of color using adapalene 0.3%-benzoyl peroxide 2.5%: a prospective real-world study. J Drugs Dermatol. 2019;18(5):514.
19. Callender VD, Preston N, Osborn C, et al. A meta-analysis to investigate the relation between fitzpatrick skin types and tolerability of adapalene-benzoyl peroxide topical gel in subjects with mild or moderate acne. J Clin Aesthet Dermatol. 2010;3(8):15-19.
20. Grimes P, Callender V. Tazarotene cream for postinflammatory hyperpigmentation and acne vulgaris in darker skin: a double-blind, randomized, vehiclecontrolled study. Cutis. 2006;77(1):45-50.
21. Charrow A, Xia FD, Joyce C, Mostaghimi A. Diversity in dermatology clinical trials: a systematic review. JAMA Dermatol. 2017;153(2):193-198.
22. He SY, McCulloch CE, Boscardin WJ, et al. Self-reported pigmentary phenotypes and race are significant but incomplete predictors of Fitzpatrick skin phototype in an ethnically diverse population. J Am Acad Dermatol. 2014;71(4):731-737.
23. Culp L, Moradi Tuchayi S, Alinia H, Feldman SR. Tolerability of topical retinoids: Are there clinically meaningful differences among topical retinoids? J Cutan Med Surg. 2015;19(6):530-538.
AUTHOR CORRESPONDENCE
Neal Bhatia MD dsbconsulting37@gmail.com
