INTRODUCTION
Plaque psoriasis and atopic dermatitis (AD) are chronic, immune-mediated skin diseases associated with a high burden of disease as well as a reduced quality of life.1 Although multiple options are available for the treatment of plaque psoriasis and AD, there is a need for efficacious topical therapies that can be used without restrictions on body surface area, anatomic locations, or duration of treatment.2-4
Tapinarof (VTAMA®; Dermavant Sciences, Inc., USA) is a first-in-class, non-steroidal, topical, aryl hydrocarbon receptor agonist approved by the Food and Drug Administration (FDA) for the treatment of plaque psoriasis in adults, and under investigation for the treatment of psoriasis in children and atopic dermatitis in adults and children.4-7 Tapinarof specifically binds to and activates the aryl hydrocarbon receptor, a ligand-dependent transcription factor with roles in the regulation of cytokine and skin barrier protein expression, and antioxidant activity.4,8,9
The efficacy and safety of tapinarof cream 1% QD have been demonstrated in a comprehensive phase 3 psoriasis pivotal trial program (PSOARING 1, 2, and 3),10,11 and are being further evaluated in a pivotal clinical trial program in adults and children with AD (ADORING 1, 2, and 3).
The US Food and Drug Administration (FDA) provides recommendations for evaluating the potential for skin irritation and sensitization with new topical therapies as well as phototoxic and photoallergic potential.12,13 Here, we report results from 4 randomized, controlled, phase 1 trials evaluating the dermal safety of topical tapinarof cream 1%. These trials were conducted to comprehensively assess the dermal safety of topical tapinarof cream 1% compared with appropriate controls, as required by the FDA for all topical investigational drugs. The formulation and concentration of tapinarof used in all 4 of the present trials is the same as that used in the pivotal phase 3 psoriasis trial program (PSOARING) and the
Tapinarof (VTAMA®; Dermavant Sciences, Inc., USA) is a first-in-class, non-steroidal, topical, aryl hydrocarbon receptor agonist approved by the Food and Drug Administration (FDA) for the treatment of plaque psoriasis in adults, and under investigation for the treatment of psoriasis in children and atopic dermatitis in adults and children.4-7 Tapinarof specifically binds to and activates the aryl hydrocarbon receptor, a ligand-dependent transcription factor with roles in the regulation of cytokine and skin barrier protein expression, and antioxidant activity.4,8,9
The efficacy and safety of tapinarof cream 1% QD have been demonstrated in a comprehensive phase 3 psoriasis pivotal trial program (PSOARING 1, 2, and 3),10,11 and are being further evaluated in a pivotal clinical trial program in adults and children with AD (ADORING 1, 2, and 3).
The US Food and Drug Administration (FDA) provides recommendations for evaluating the potential for skin irritation and sensitization with new topical therapies as well as phototoxic and photoallergic potential.12,13 Here, we report results from 4 randomized, controlled, phase 1 trials evaluating the dermal safety of topical tapinarof cream 1%. These trials were conducted to comprehensively assess the dermal safety of topical tapinarof cream 1% compared with appropriate controls, as required by the FDA for all topical investigational drugs. The formulation and concentration of tapinarof used in all 4 of the present trials is the same as that used in the pivotal phase 3 psoriasis trial program (PSOARING) and the
