title: Two Multicenter, Randomized, Double-Blind, Parallel Group Comparison Studies of a Novel Enhanced Lotion Formulation of Halobetasol Propionate, 0.05% Versus Its Vehicle in Adult Subjects With Plaque Psoriasis.
abstract: <p>BACKGROUND: A novel lotion formulation of halobetasol propionate, 0.05% (HBP Lotion) with enhanced vehicle characteristics of a cream while preserving the ease of use and cosmetic elegance of a lotion has been developed to treat plaque psoriasis.
  
  
  OBJECTIVE
  Determine the safety and effectiveness of HBP Lotion in patients with plaque psoriasis.
  
  
  METHODS
  Two prospective, randomized, vehicle-controlled clinical studies were conducted in 443 adult subjects with moderate-severe plaque psoriasis. Subjects applied the test article to psoriatic plaques within the treatment area twice daily for 14 days. Efficacy data are based upon treatment "success" defined as those subjects that achieved scores of 0=clear or 1=almost clear with at least a two-grade improvement relative to baseline for an Investigator's Global Assessment (IGA) and clinical signs (plaque elevation, erythema, scaling). Safety data are presented as adverse events and local skin reactions.
  
  
  RESULTS
  After two weeks of treatment with HBP Lotion, 44.5% of the HBP Lotion treated subjects in each study achieved (a) treatment "success" (ie, an IGA score of 0=clear or 1=almost clear and >2 grade improvement compared to baseline) and (b) a notable reduction in plaque elevation, erythema, scaling, and pruritus. In contrast, only 6.3% and 7.1% of VEH subjects in Studies 1 and 2, respectively, achieved treatment success and the reduction of disease related signs was materially lower. Statistically, at day 15 in both Phase 3 studies, treatment success with HBP Lotion was superior to VEH (P less than 0.001). From a safety perspective the outcomes were in general unremarkable with similar findings in the HBP Lotion and VEH treatment groups.
  
  
  CONCLUSIONS
  The results demonstrate the safety and effectiveness of HBP Lotion in the treatment of plaque psoriasis. Furthermore, this novel HBP lotion formulation is also distinguished by its moisturization qualities and ease of use.</p> <p><em>J Drugs Dermatol. 2017;16(3):234-240.</em></p>.
authors.forename: David
authors.initials: D
authors.lastname: Pariser
authors.forename: Michael
authors.initials: M
authors.lastname: Bukhalo
authors.forename: Scott
authors.initials: S
authors.lastname: Guenthner
authors.forename: Steven
authors.initials: S
authors.lastname: Kempers
authors.forename: Stephen
authors.initials: S
authors.lastname: Shideler
authors.forename: Linda Stein
authors.initials: LS
authors.lastname: Gold
authors.forename: Eduardo
authors.initials: E
authors.lastname: Tschen
authors.forename: Jim
authors.initials: J
authors.lastname: Berg
authors.forename: Mary Beth
authors.initials: MB
authors.lastname: Ferdon
authors.forename: Syd
authors.initials: S
authors.lastname: Dromgoole
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D002990:Clobetasol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D014677:Pharmaceutical Vehicles / Q000008:administration & dosage; D011446:Prospective Studies; D011565:Psoriasis / Q000188:drug therapy*; D012720:Severity of Illness Index; D063465:Skin Cream; D016896:Treatment Outcome
chemical_list: D005938:Glucocorticoids; D014677:Pharmaceutical Vehicles; C064466:halobetasol; D002990:Clobetasol