title: A randomized trial of the off-label use of imiquimod, 5%, cream with vs without tazarotene, 0.1%, gel for the treatment of lentigo maligna, followed by conservative staged excisions.
abstract: OBJECTIVE
  To determine if the complete response rates of lentigo maligna (LM) to imiquimod, 5%, cream can be improved by the addition of a topical retinoid.
  
  
  METHODS
  Prospective randomized study of patients treated with imiquimod alone vs imiquimod plus a topical retinoid, followed by conservative staged excisions.
  
  
  METHODS
  Mohs surgical clinic in an academic institution.
  
  
  METHODS
  Ninety patients with biopsy-confirmed LM.
  
  
  METHODS
  Ninety patients with 91 LMs were randomized into 2 groups. One group received imiquimod, 5%, cream 5 d/wk for 3 months, while the other group also received tazarotene, 0.1%, gel 2 d/wk for 3 months. Following topical therapy, all patients underwent staged excisions and frozen section analysis with Melan-A immunostaining to confirm negative margins.
  
  
  METHODS
  The presence or absence of residual LM at the time of staged excision.
  
  
  RESULTS
  Forty-six patients with 47 LMs were randomized to receive monotherapy: 42 of 47 LMs reached the intended treatment duration, with 27 complete responses (64%). Forty-four patients with 44 LMs were randomized to receive combined therapy: 37 of 44 LMs reached the intended treatment duration, with 29 complete responses (78%). This difference did not reach statistical significance (P=.17). There have been no recurrences to date, with a mean follow-up period of 42 months.
  
  
  CONCLUSIONS
  Among patients who received topical imiquimod with vs without tazarotene, 22% (8 of 37) of lesions vs 36% (15 of 42) of lesions showed residual LM on staged excisions. Pretreating LM with imiquimod, 5%, cream may decrease surgical defect sizes; however, total reliance on topical imiquimod as an alternative to surgery may put the patient at increased risk of a local recurrence.
authors.affiliation: Department of Dermatology, The University of Utah, Salt Lake City, UT 84112, USA. Mark.hyde@hci.utah.edu
authors.forename: Mark A
authors.initials: MA
authors.lastname: Hyde
authors.forename: Michael L
authors.initials: ML
authors.lastname: Hadley
authors.forename: Payam
authors.initials: P
authors.lastname: Tristani-Firouzi
authors.forename: David
authors.initials: D
authors.lastname: Goldgar
authors.forename: Glen M
authors.initials: GM
authors.lastname: Bowen
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000634:Aminoquinolines / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000008:administration & dosage; D001706:Biopsy; D002610:Cheek; D003879:Dermatologic Agents / Q000008:administration & dosage; D003937:Diagnosis, Differential; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005500:Follow-Up Studies; D005782:Gels; D006801:Humans; D018327:Hutchinson's Melanotic Freckle / Q000175:diagnosis / Q000188:drug therapy* / Q000601:surgery; D000077271:Imiquimod; D008875:Middle Aged; D015580:Mohs Surgery / Q000379:methods*; D009539:Nicotinic Acids / Q000008:administration & dosage*; D056687:Off-Label Use; D009824:Ointments; D011182:Postoperative Care / Q000379:methods*; D011446:Prospective Studies; D012878:Skin Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000601:surgery; D016896:Treatment Outcome; D012176:Retinoids
chemical_list: D000634:Aminoquinolines; D000970:Antineoplastic Agents; D003879:Dermatologic Agents; D005782:Gels; D000077271:Imiquimod; D009539:Nicotinic Acids; D009824:Ointments; C086827:tazarotene; D012176:Retinoids