Long-term safety results from a phase 3 open-label study of a fixed combination halobetasol propionate 0.01% and tazarotene 0.045% lotion in moderate-to-severe plaque psoriasis

Lebwohl, Mark; Sugarman, Jeffrey; Gold, Linda F Stein; Pariser, David M.; Lin, Tina; Pillai, Radhakrishnan; Martin, Gina; Harris, Susan; Israel, Robert J.

doi:10.1016/j.jaad.2018.09.002

Cited by 21 publications

(31 citation statements)

References 7 publications

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“…27 Long-term efficacy and safety results (up to 1 year) of HP/TAZ have been reported by Lebwohl et al in an openlabel, phase III study (n=555) in adults with moderate-tosevere plaque psoriasis, defined as having a baseline IGA of 3 or 4. 28 In this study, 4.7% and 20.9% of subjects discontinued treatment with HP/TAZ by weeks 12 and 24, respectively, due to inefficacy. 28 The most commonly reported treatment-related adverse events were application site reactions resulting in dermatitis, pruritus, and pain, with 7.5% of subjects discontinuing treatment with HP/ TAZ due to these side effects.…”

Section: Dovepressmentioning

confidence: 61%

“…28 In this study, 4.7% and 20.9% of subjects discontinued treatment with HP/TAZ by weeks 12 and 24, respectively, due to inefficacy. 28 The most commonly reported treatment-related adverse events were application site reactions resulting in dermatitis, pruritus, and pain, with 7.5% of subjects discontinuing treatment with HP/ TAZ due to these side effects. 28 Overall, the incidence of adverse events peaked around day 60 of the trial and remained stable from day 90 until the end of the study.…”

Section: Dovepressmentioning

confidence: 61%

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<p>Impact of Halobetasol Propionate and Tazarotene Lotion 0.01%/0.045% in the Management of Plaque Psoriasis in Adults</p>

Reddy

Myers

Yang

et al. 2020

CCID

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Halobetasol propionate and tazarotene lotion 0.01%/0.045% (HP/TAZ) is a topical medication approved for the treatment of plaque psoriasis in adults. As a treatment modality, HP/TAZ has a combinatory therapeutic effect because it contains both a corticosteroid (HP) and a retinoid (TAZ) component. Here, we review the important clinical efficacy and safety data derived from pivotal clinical trials for HP/TAZ in the treatment of plaque psoriasis. We also discuss the mechanism of action, dosage guidelines, pharmacokinetics/pharmacodynamics, and clinical considerations for HP/TAZ, including why HP/TAZ should be avoided in pregnant patients.

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Section: Dovepressmentioning

confidence: 61%

Section: Dovepressmentioning

confidence: 61%

<p>Impact of Halobetasol Propionate and Tazarotene Lotion 0.01%/0.045% in the Management of Plaque Psoriasis in Adults</p>

Reddy

Myers

Yang

et al. 2020

CCID

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“…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…”

Section: Discussionmentioning

confidence: 99%

Successful Management of a Black Male With Psoriasis and Dyspigmentation Treated With Halobetasol Propionate 0.01%/Tazarotene 0.045% Lotion: Case Report

Desai¹,

Alexis²,

Jacobson³

2020

JDD

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Skin of color patients with psoriasis face unique challenges related to disease characteristics and treatment. Dyspigmentation, including postinflammatory hypo-and hyperpigmentation, more frequently and severely affects patients with skin of color and remains a challenge in psoriasis management. We present the case of a 58-year-old Black male with moderate psoriasis who was treated for 8 weeks with a fixed combination halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion during a phase 3 study (NCT02462070). HP/TAZ was efficacious in this patient, whose Investigator's Global Assessment score decreased from 3 (moderate) at baseline to 1 (almost clear) within 4 weeks, with maintenance of "almost clear" through week 12 (4 weeks posttreatment). Affected body surface area decreased by 50% and quality of life greatly improved from baseline to week 8. The patient experienced dyspigmentation of the affected skin during the trial; hypopigmentation was primarily experienced from weeks 2-8, with the greatest degree at week 4. By week 12, the affected skin area had returned to normal, with only small regions of hyperpigmentation, primarily around the periphery of the lesion. These results indicate that HP/TAZ may be a treatment option for patients with skin of color, who are disproportionally affected by postinflammatory dyspigmentation.

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“…Finally, in a long-term open-label study, subjects with moderate-to-severe plaque psoriasis were treated for 8 weeks with HP plus tazarotene (HP/TAZ) lotion, with additional treatment being administered in 4-week cycles as needed for up to 1 year [38]. This study reported on the long-term safety profile of HP/ TAZ, including assessments of AEs and tolerability.…”

Section: Long-term Clinical Studies Of Topical Agents For Treatment Omentioning

confidence: 99%

PSO-LONG: Design of a Novel, 12-Month Clinical Trial of Topical, Proactive Maintenance with Twice-Weekly Cal/BD Foam in Psoriasis

Gold

Alonso‐Llamazares

Lacour³

et al. 2020

Adv Ther

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Background: Psoriasis vulgaris is commonly treated with topical corticosteroids and vitamin D analogues. Although potent and superpotent topical corticosteroids are very effective at clearing psoriasis, with short-term reactive treatment durations, symptoms usually recur after treatment discontinuation, necessitating long-term disease management strategies. A foam formulation of calcipotriol and betamethasone dipropionate (Cal/BD foam), consisting of calcipotriol 50 lg/g and betamethasone dipropionate 0.5 mg/g, is approved for the daily treatment of psoriasis for up to 4 weeks. Here, we describe a clinical trial protocol for evaluating the long-term safety and efficacy of twice-weekly Cal/BD foam as a proactive topical maintenance therapy for plaque psoriasis for up to 52 weeks. Objective: The aim of this trial was to evaluate the safety and efficacy of Cal/BD foam when Digital Features To view digital features for this article, go to

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Long-term safety results from a phase 3 open-label study of a fixed combination halobetasol propionate 0.01% and tazarotene 0.045% lotion in moderate-to-severe plaque psoriasis

Cited by 21 publications

References 7 publications

<p>Impact of Halobetasol Propionate and Tazarotene Lotion 0.01%/0.045% in the Management of Plaque Psoriasis in Adults</p>

<p>Impact of Halobetasol Propionate and Tazarotene Lotion 0.01%/0.045% in the Management of Plaque Psoriasis in Adults</p>

Successful Management of a Black Male With Psoriasis and Dyspigmentation Treated With Halobetasol Propionate 0.01%/Tazarotene 0.045% Lotion: Case Report

PSO-LONG: Design of a Novel, 12-Month Clinical Trial of Topical, Proactive Maintenance with Twice-Weekly Cal/BD Foam in Psoriasis

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