title: Relief of pruritus in patients with atopic dermatitis after treatment with topical doxepin cream. The Doxepin Study Group.
abstract: BACKGROUND
  Atopic dermatitis is associated with severe pruritus for which effective topical treatment is lacking. As a potent H1 and H2 antagonist, the antipruritic effect of topical doxepin was first demonstrated in histamine-induced itch in nonatopic volunteers.
  
  
  OBJECTIVE
  The current study was undertaken to compare the efficacy and safety of topical 5% doxepin cream in relieving pruritus associated with atopic dermatitis.
  
  
  METHODS
  A total of 270 patients with atopic dermatitis who had daily moderate to severe pruritus for at least 1 week were enrolled in the double-blind, vehicle-controlled, multicenter study. Treatment was randomly assigned: 5% doxepin cream or vehicle cream was applied twice on the day of the baseline visit and four times daily for the remainder of the 7-day trial.
  
  
  RESULTS
  Relief of pruritus was achieved in 85% of doxepin-treated patients and 57% of vehicle-treated patients by day 7; a majority of these positive responses occurred during the first 24 hours. Pruritus severity scores demonstrated significantly greater improvement with topical doxepin at each study visit (p < 0.01). Visual analogue scales for pruritus severity and pruritus relief showed similar improvement in the doxepin-treated group. At each of three visits, the physician's global evaluation for relief of pruritus also showed significant improvement in the doxepin treatment group (p < 0.01). The physician's global evaluations of eczema significantly favored topical doxepin on day 7 (p < 0.01). Nineteen patients withdrew from the study because of adverse effects (doxepin, n = 16; vehicle, n = 3). The most commonly reported were localized stinging or burning (doxepin group, n = 39; vehicle group, n = 34) and drowsiness (doxepin group, n = 37; vehicle group, n = 3), all of which decreased in frequency and severity over time.
  
  
  CONCLUSIONS
  Topical doxepin is effective in reducing pruritus in patients with atopic dermatitis. It has an apparent short-term low risk of major side effects or sensitization.
authors.affiliation: Massachusetts General Hospital, Boston.
authors.forename: L A
authors.initials: LA
authors.lastname: Drake
authors.forename: J D
authors.initials: JD
authors.lastname: Fallon
authors.forename: A
authors.initials: A
authors.lastname: Sober
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D003876:Dermatitis, Atopic / Q000150:complications*; D004311:Double-Blind Method; D004316:Doxepin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004485:Eczema / Q000188:drug therapy / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D014677:Pharmaceutical Vehicles; D011537:Pruritus / Q000188:drug therapy*; D012894:Sleep Stages / Q000187:drug effects; D013997:Time Factors
chemical_list: D014677:Pharmaceutical Vehicles; D004316:Doxepin