should examine the effects of age and gender on tolerability to
better understand the treatment needs of this population.
CONCLUSION
Results from this pooled post hoc analysis from two identical
phase 3 studies demonstrate that tazarotene 0.045% lotion
significantly reduced acne lesions and led to higher rates of
treatment success versus vehicle in female and male participants
with moderate-to-severe acne. Overall AE rates were low,
with favorable tolerability in both sexes. Together, these data
demonstrate this hydrating polymeric lotion formulation of tazarotene
is both an efficacious and well tolerated treatment for
acne in females and males.
DISCLOSURES
Leon Kircik has acted as an investigator, advisor, speaker, and
consultant for Ortho Dermatologics. Linda Stein Gold has
served as investigator/consultant or speaker for Ortho Dermatologics,
LEO, Dermavant, Incyte, Novartis, AbbVie, Galderma,
Sol-Gel, Foamix, and Lilly. Kenneth Beer has received funding
from Allergan, Galderma, Evolus, and Revance. Jerry Tan has
served as an advisor, investigator/consultant or speaker for
Bausch Health and Ortho Dermatologics. Hilary Baldwin has
served as advisor, investigator, and on speakers’ bureaus for
Almiral, Cassiopea, Foamix, Galderma, Ortho Dermatologics,
Sol Gel, and Sun Pharmaceuticals. Eric Guenin is an employee
of Ortho Dermatologics and may hold stock and/or stock options
in its parent company. Robert Kang and Johnson Varughese are
employees of Bausch Health US, LLC and may hold stock and/or
stock options in its parent company.
ACKNOWLEDGMENT
Medical writing support was provided by Lynn M. Anderson,
PhD and Jacqueline Benjamin, PhD of Prescott Medical Communications
Group (Chicago, IL) with financial support from Ortho
Dermatologics. Ortho Dermatologics is a division of Bausch
Health US, LLC.
REFERENCES
1. Zaenglein AL, Pathy AL, Schlosser BJ, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016;74(5):945-973.e933.
2. Skroza N, Tolino E, Mambrin A, et al. Adult acne versus adolescent acne: A retrospective study of 1,167 patients. J Clin Aesthet Dermatol. 2018;11(1):21- 25.
3. Zeichner JA, Baldwin HE, Cook-Bolden FE, et al. Emerging issues in adult female acne. J Clin Aesthet Dermatol. 2017;10(1):37-46.
4. 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 e21.
5. Luebberding S, Krueger N, Kerscher M. Skin physiology in men and women: in vivo evaluation of 300 people including TEWL, SC hydration, sebum content and skin surface pH. Int J Cosmet Sci. 2013;35(5):477-483.
6. Khunger N, Mehrotra K. Menopausal acne - challenges and solutions. Int J Womens Health. 2019;11:555-567.
7. Leyden J, Stein-Gold L, Weiss J. Why topical retinoids are mainstay of therapy for acne. Dermatol Ther (Heidelb). 2017;7(3):293-304.
8. Chien A. Retinoids in acne management: Review of current understanding, future considerations, and focus on topical treatments. J Drugs Dermatol. 2018;17(12):s51-55.
9. 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.
10. 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.
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. Yeh L, Bonati LM, Silverberg NB. Topical retinoids for acne. Semin Cutan Med Surg. 2016;35(2):50-56.
13. Thielitz A, Gollnick H. Topical retinoids in acne vulgaris: update on efficacy and safety. Am J Clin Dermatol. 2008;9(6):369-381. 14. 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.
15. 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):542-548.
16. Tanghetti EA, Werschler WP, Lain T, Guenin E. 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.
17. Hoffman LK, Bhatia N, Zeichner J, Kircik LH. Topical vehicle formulations in the treatment of acne. J Drugs Dermatol. 2018;17(6):s6-s10.
2. Skroza N, Tolino E, Mambrin A, et al. Adult acne versus adolescent acne: A retrospective study of 1,167 patients. J Clin Aesthet Dermatol. 2018;11(1):21- 25.
3. Zeichner JA, Baldwin HE, Cook-Bolden FE, et al. Emerging issues in adult female acne. J Clin Aesthet Dermatol. 2017;10(1):37-46.
4. 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 e21.
5. Luebberding S, Krueger N, Kerscher M. Skin physiology in men and women: in vivo evaluation of 300 people including TEWL, SC hydration, sebum content and skin surface pH. Int J Cosmet Sci. 2013;35(5):477-483.
6. Khunger N, Mehrotra K. Menopausal acne - challenges and solutions. Int J Womens Health. 2019;11:555-567.
7. Leyden J, Stein-Gold L, Weiss J. Why topical retinoids are mainstay of therapy for acne. Dermatol Ther (Heidelb). 2017;7(3):293-304.
8. Chien A. Retinoids in acne management: Review of current understanding, future considerations, and focus on topical treatments. J Drugs Dermatol. 2018;17(12):s51-55.
9. 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.
10. 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.
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. Yeh L, Bonati LM, Silverberg NB. Topical retinoids for acne. Semin Cutan Med Surg. 2016;35(2):50-56.
13. Thielitz A, Gollnick H. Topical retinoids in acne vulgaris: update on efficacy and safety. Am J Clin Dermatol. 2008;9(6):369-381. 14. 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.
15. 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):542-548.
16. Tanghetti EA, Werschler WP, Lain T, Guenin E. 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.
17. Hoffman LK, Bhatia N, Zeichner J, Kircik LH. Topical vehicle formulations in the treatment of acne. J Drugs Dermatol. 2018;17(6):s6-s10.
AUTHOR CORRESPONDENCE
Leon H. Kircik MD wedoderm@yahoo.com
