title: A Phase 2, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of a Halobetasol/Tazarotene Fixed Combination in the Treatment of Plaque Psoriasis.
abstract: <p>BACKGROUND: Psoriasis is a chronic, immune-mediated disease that varies widely in its clinical expression. Treatment options focus on relieving symptoms, reducing inflammation, induration, and scaling, and controlling the extent of the disease. Topical corticosteroids are the mainstay of treatment, however long-term safety remains a concern, particularly with the more potent formulations. Combination therapy with a corticosteroid and tazarotene may improve psoriasis signs at a lower corticosteroid concentration providing a superior safety profile.
  
  
  OBJECTIVE
  To investigate the efficacy and safety of a once-daily application of a fixed combination halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ) lotion in comparison with its monads and vehicle in subjects with moderate-to-severe plaque psoriasis.
  
  
  METHODS
  Multicenter, randomized, double-blind, vehicle-controlled Phase 2 study in moderate or severe psoriasis (N=212). Subjects randomized (2:2:2:1 ratio) to receive HP/TAZ, individual monads, or vehicle, once-daily for 8 weeks. Efficacy assessments included treatment success (defined as at least a 2-grade improvement from baseline in the IGA score and a score of 'Clear' or 'Almost Clear'), and impact on individual signs of psoriasis (erythema, plaque elevation, and scaling) at the target lesion. Safety and treatment emergent adverse events (TEAEs) were evaluated throughout.
  
  
  RESULTS
  HP/TAZ lotion demonstrated statistically significant superiority over vehicle as early as 2 weeks. At week 8, 52.5% of subjects had treatment success compared with 33.3%, 18.6%, and 9.7% in the HP (P=0.033), TAZ (P less than 0.001), and vehicle (P less than 0.001) groups, respectively. HP/TAZ lotion was superior to its monads and vehicle in reducing the psoriasis signs of erythema, plaque elevation, and scaling at the target lesion. At week 8, a 2-grade improvement in IGA was achieved by 54.2% of subjects for erythema, 67.8% for plaque elevation, and 64.4% for scaling. Most frequently reported TEAEs were application site reactions, and were more likely associated with the tazarotene component. Side effects such as skin atrophy were rare.
  
  
  CONCLUSIONS
  HP/TAZ lotion was consistently more effective than its monads or vehicle in achieving treatment success and reducing psoriasis signs of erythema, plaque elevation, and scaling at the target lesion. Safety data were consistent with the known safety profile of halobetasol propionate and tazarotene, and did not reveal any new safety concerns with the combination product.</p> <p><em>J Drugs Dermatol. 2017;16(3):197-204.</em></p>.
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Sugarman
authors.forename: Linda Stein
authors.initials: LS
authors.lastname: Gold
authors.forename: Mark G
authors.initials: MG
authors.lastname: Lebwohl
authors.forename: David M
authors.initials: DM
authors.lastname: Pariser
authors.forename: Binu J
authors.initials: BJ
authors.lastname: Alexander
authors.forename: Radhakrishnan
authors.initials: R
authors.lastname: Pillai
mesh_terms: D000279:Administration, Cutaneous; D002990:Clobetasol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D009539:Nicotinic Acids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014677:Pharmaceutical Vehicles / Q000008:administration & dosage; D011565:Psoriasis / Q000188:drug therapy*; D012720:Severity of Illness Index; D063465:Skin Cream; D016896:Treatment Outcome; D012176:Retinoids
chemical_list: D002990:Clobetasol; D003879:Dermatologic Agents; D004338:Drug Combinations; D005938:Glucocorticoids; D009539:Nicotinic Acids; D014677:Pharmaceutical Vehicles; C086827:tazarotene; D012176:Retinoids; C064466:halobetasol