stimulating keratinocyte turnover (promoting loss of melanin), reducing/inhibiting melanosome transfer to keratinocytes, and interrupting melanin synthesis.22,26 TAZ has also been shown to downregulate markers of cell proliferation and inflammation such as IL-6,12,13 which is known to have hypopigmenting effects.18
The fixed combination HP 0.01%/TAZ 0.045% lotion used by the patient in this case report has additional efficacy and safety benefits. The new polymeric emulsion technology used to develop HP/TAZ lotion allows for efficient permeation of the active ingredients into the dermal layers, at around half the concentration of traditional topical formulations.10 Further, HP/ TAZ lotion has demonstrated synergistic activity, with efficacy greater than that which would be predicted from the individual active ingredients.10 The maintenance of therapeutic effect seen in this patient—who sustained disease reduction 4 weeks posttreatment—is likely due to the mechanism of action of TAZ in psoriasis, which restores skin to a quiescent, prelesional status.27 However, when used alone, TAZ can cause cutaneous irritation; HP alone can also result in AEs that limit long term use. These safety limitations can be minimized when combining HP with TAZ.10,11 The patient in this case report did not report any adverse events—including any application or irritation events— and local skin reactions were limited. Though the patient was limited to 8-weeks of HP/TAZ treatment as part of the clinical trial design, treatment with HP/TAZ for up to 1 year (maximum 24 weeks of continuous use) in an open-label, long-term study (NCT02462083) has demonstrated a favorable safety profile.28
The fixed combination HP 0.01%/TAZ 0.045% lotion used by the patient in this case report has additional efficacy and safety benefits. The new polymeric emulsion technology used to develop HP/TAZ lotion allows for efficient permeation of the active ingredients into the dermal layers, at around half the concentration of traditional topical formulations.10 Further, HP/ TAZ lotion has demonstrated synergistic activity, with efficacy greater than that which would be predicted from the individual active ingredients.10 The maintenance of therapeutic effect seen in this patient—who sustained disease reduction 4 weeks posttreatment—is likely due to the mechanism of action of TAZ in psoriasis, which restores skin to a quiescent, prelesional status.27 However, when used alone, TAZ can cause cutaneous irritation; HP alone can also result in AEs that limit long term use. These safety limitations can be minimized when combining HP with TAZ.10,11 The patient in this case report did not report any adverse events—including any application or irritation events— and local skin reactions were limited. Though the patient was limited to 8-weeks of HP/TAZ treatment as part of the clinical trial design, treatment with HP/TAZ for up to 1 year (maximum 24 weeks of continuous use) in an open-label, long-term study (NCT02462083) has demonstrated a favorable safety profile.28
CONCLUSION
In conclusion, this case report in a Black male patient
demonstrates that this new formulation of HP 0.01%/TAZ
0.045% lotion was efficacious in the treatment of psoriasis,
with treatment success achieved early and maintained 4 weeks
posttreatment. Hypopigmentation was evident during resolution
of disease, though had completely resolved by week 12 with
minimal hyperpigmentation observed. These results indicate
that HP/TAZ may be a treatment option for patients with skin of
color, who are disproportionally affected by postinflammatory
dyspigmentation.
DISCLOSURES
Seemal Desai has served as a research investigator and/or
consultant for Skinmedica, Ortho Dermatologics, Galderma,
Pfizer, Dermavant, Almirall, Dermira, and Watson.
Andrew F. Alexis has received grant/research support (funds
to institution) from Leo, Novartis, Almirall, Bristol-Myers-
Squibb, Celgene, Menlo, Galderma, Bausch Health, and Cara;
and has served as a consultant/advisory board member for
Leo, Novartis, Menlo, Galderma, Pfizer, Sanofi-Regeneron,
Dermavant, Unilever, Celgene, Beiersdorf, L’Oreal, BMS, Menlo,
Scientis, Bausch Health, UCB, and Foamix.Abby Jacobson is an employee of Ortho Dermatologics and
may hold stock and/or stock options in its parent company.
ACKNOWLEDGMENTS
The studies were funded by Ortho Dermatologics.
Medical writing support was 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. Gelfand JM, Stern RS, Nijsten T, et al. The prevalence of psoriasis in African Americans: Results from a population-based study. J Am Acad Dermatol. 2005;52(1):23-26.
2. Alexis AF, Blackcloud P. Psoriasis in skin of color: Epidemiology, genetics, clinical presentation, and treatment nuances. J Clin Aesthet Dermatol. 2014;7(11):16-24.
3. Alexis AF, Sergay AB, Taylor SC. Common dermatologic disorders in skin of color: A comparative practice survey. Cutis. 2007;80(5):387-394.
4. Davis EC, Callender VD. Postinflammatory hyperpigmentation: A review of the epidemiology, clinical features, and treatment options in skin of color. J Clin Aesthet Dermatol. 2010;3(7):20-31.
5. Desai SR. Hyperpigmentation therapy: a review. J Clin Aesthet Dermatol. 2014;7(8):13-17.
6. Shah SK, Arthur A, Yang YC, et al. A retrospective study to investigate racial and ethnic variations in the treatment of psoriasis with etanercept. J Drugs Dermatol. 2011;10(8):866-872.
7. Kaufman BP, Alexis AF. Psoriasis in skin of color: Insights into the epidemiology, clinical presentation, genetics, quality-of-life impact, and treatment of psoriasis in non-White racial/ethnic groups. Am J Clin Dermatol. 2018;19(3):405-423.
8. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol. 2009;60(4):643-659.
9. Uva L, Miguel D, Pinheiro C, et al. Mechanisms of action of topical corticosteroids in psoriasis. Int J Endocrinol. 2012;2012:561018.
10. 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.
11. Tanghetti E, Lebwohl M, Stein Gold L. Tazarotene revisited: Safety and efficacy in plaque psoriasis and its emerging role in treatment strategy. J Drugs Dermatol. 2018;17(12):1280-1287.
12. Duvic M, Nagpal S, Asano AT, Chandraratna RA. Molecular mechanisms of tazarotene action in psoriasis. J Am Acad Dermatol. 1997;37(2 Pt 3):S18-24.
13. Duvic M, Asano AT, Hager C, Mays S. The pathogenesis of psoriasis and the mechanism of action of tazarotene. J Am Acad Dermatol. 1998;39(4 Pt 2):S129-133.
14. Gold LS, Lebwohl MG, Sugarman JL, et al. Safety and efficacy of a fixed combination of halobetasol and tazarotene in the treatment of moderate-tosevere plaque psoriasis: Results of 2 phase 3 randomized controlled trials. J Am Acad Dermatol. 2018;79(2):287-293.
15. Sugarman JL, Weiss J, Tanghetti EA, et al. Safety and efficacy of a fixed combination halobetasol and tazarotene lotion in the treatment of moderateto- severe plaque psoriasis: A pooled analysis of two phase 3 studies. J Drugs Dermatol. 2018;17(8):855-861.
16. Basra MK, Salek MS, Camilleri L, et al. Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): Further data. Dermatology. 2015;230(1):27-33.
17. Kelly AP. Keloids. Dermatol Clin. 1988;6(3):413-424.
18. Wang CQF, Akalu YT, Suarez-Farinas M, et al. IL-17 and TNF synergistically modulate cytokine expression while suppressing melanogenesis: Potential relevance to psoriasis. J Invest Dermatol. 2013;133(12):2741-2752.
19. Wasmeier C, Hume AN, Bolasco G, Seabra MC. Melanosomes at a glance. J Cell Sci. 2008;121(Pt 24):3995-3999.
20. Vachiramon V, Thadanipon K. Postinflammatory hypopigmentation. Clin Exp Dermatol. 2011;36(7):708-714.
21. Abdel-Naser MB, Liakou AI, Elewa R, et al. Increased activity and number of epidermal melanocytes in lesional psoriatic skin. Dermatology. 2016;232(4):425-430.
22. Vashi NA, Kundu RV. Facial hyperpigmentation: Causes and treatment. Br J Dermatol. 2013;169 Suppl 3:41-56.
2. Alexis AF, Blackcloud P. Psoriasis in skin of color: Epidemiology, genetics, clinical presentation, and treatment nuances. J Clin Aesthet Dermatol. 2014;7(11):16-24.
3. Alexis AF, Sergay AB, Taylor SC. Common dermatologic disorders in skin of color: A comparative practice survey. Cutis. 2007;80(5):387-394.
4. Davis EC, Callender VD. Postinflammatory hyperpigmentation: A review of the epidemiology, clinical features, and treatment options in skin of color. J Clin Aesthet Dermatol. 2010;3(7):20-31.
5. Desai SR. Hyperpigmentation therapy: a review. J Clin Aesthet Dermatol. 2014;7(8):13-17.
6. Shah SK, Arthur A, Yang YC, et al. A retrospective study to investigate racial and ethnic variations in the treatment of psoriasis with etanercept. J Drugs Dermatol. 2011;10(8):866-872.
7. Kaufman BP, Alexis AF. Psoriasis in skin of color: Insights into the epidemiology, clinical presentation, genetics, quality-of-life impact, and treatment of psoriasis in non-White racial/ethnic groups. Am J Clin Dermatol. 2018;19(3):405-423.
8. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol. 2009;60(4):643-659.
9. Uva L, Miguel D, Pinheiro C, et al. Mechanisms of action of topical corticosteroids in psoriasis. Int J Endocrinol. 2012;2012:561018.
10. 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.
11. Tanghetti E, Lebwohl M, Stein Gold L. Tazarotene revisited: Safety and efficacy in plaque psoriasis and its emerging role in treatment strategy. J Drugs Dermatol. 2018;17(12):1280-1287.
12. Duvic M, Nagpal S, Asano AT, Chandraratna RA. Molecular mechanisms of tazarotene action in psoriasis. J Am Acad Dermatol. 1997;37(2 Pt 3):S18-24.
13. Duvic M, Asano AT, Hager C, Mays S. The pathogenesis of psoriasis and the mechanism of action of tazarotene. J Am Acad Dermatol. 1998;39(4 Pt 2):S129-133.
14. Gold LS, Lebwohl MG, Sugarman JL, et al. Safety and efficacy of a fixed combination of halobetasol and tazarotene in the treatment of moderate-tosevere plaque psoriasis: Results of 2 phase 3 randomized controlled trials. J Am Acad Dermatol. 2018;79(2):287-293.
15. Sugarman JL, Weiss J, Tanghetti EA, et al. Safety and efficacy of a fixed combination halobetasol and tazarotene lotion in the treatment of moderateto- severe plaque psoriasis: A pooled analysis of two phase 3 studies. J Drugs Dermatol. 2018;17(8):855-861.
16. Basra MK, Salek MS, Camilleri L, et al. Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): Further data. Dermatology. 2015;230(1):27-33.
17. Kelly AP. Keloids. Dermatol Clin. 1988;6(3):413-424.
18. Wang CQF, Akalu YT, Suarez-Farinas M, et al. IL-17 and TNF synergistically modulate cytokine expression while suppressing melanogenesis: Potential relevance to psoriasis. J Invest Dermatol. 2013;133(12):2741-2752.
19. Wasmeier C, Hume AN, Bolasco G, Seabra MC. Melanosomes at a glance. J Cell Sci. 2008;121(Pt 24):3995-3999.
20. Vachiramon V, Thadanipon K. Postinflammatory hypopigmentation. Clin Exp Dermatol. 2011;36(7):708-714.
21. Abdel-Naser MB, Liakou AI, Elewa R, et al. Increased activity and number of epidermal melanocytes in lesional psoriatic skin. Dermatology. 2016;232(4):425-430.
22. Vashi NA, Kundu RV. Facial hyperpigmentation: Causes and treatment. Br J Dermatol. 2013;169 Suppl 3:41-56.
