title: Topical tacrolimus 0.1% ointment for treatment of cutaneous Crohn's Disease.
abstract: BACKGROUND
  Cutaneous Crohn's Disease is a notoriously difficult condition to treat and causes significant morbidity, impacting heavily on quality of life. This is the first study in adults examining the effect of topical tacrolimus on the different cutaneous manifestations of Crohn's Disease.
  
  
  METHODS
  This open label observational study of 20 patients with heterogeneous forms of cutaneous Crohn's disease used topical tacrolimus 0.1% ointment once daily to affected areas for 12 weeks with a maximal total dose of 90g. Therapy was stopped at 12 weeks to assess whether the condition relapsed. Thereafter relapsing patients optionally continued an open label extension of topical tacrolimus therapy and were observed for a total of 12 months.
  
  
  RESULTS
  Of seventeen patients completing the twelve-week study, fifteen improved using a specifically designed physicians' global severity scale. One patient cleared, four showed a pronounced improvement (51-75%) and ten demonstrated a mild (1-25%) or moderate improvement (25-50%) in twelve weeks. Over twelve months eleven patients remained in the study, nine of which improved, one cleared and one showed no change. Perineal disease responded better with two out of twelve clearing, four showing pronounced benefit and four mild to moderate improvement. Long-term application of 0.1% tacrolimus applied to broken skin and mucosa was safe and serum levels of tacrolimus were undetectable in all subjects throughout the study.
  
  
  CONCLUSIONS
  0.1% tacrolimus ointment was safe and effective in treating cutaneous manifestations of Crohn's disease, particularly perineal disease and pyoderma gangrenosum, yet it seldom cleared the condition.
  
  
  BACKGROUND
  ClinicalTrials.gov Protocol Registration System ID: 33000332.
authors: Department of Dermatology, Aberdeen Royal Infirmary, Foresterhill, Aberdeen AB25 2ZB, UK.
authors: Shantini A
authors: SA
authors: Rice
authors: Pick N
authors: PN
authors: Woo
authors: Emad
authors: E
authors: El-Omar
authors: Ronald A
authors: RA
authors: Keenan
authors: Anthony D
authors: AD
authors: Ormerod
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D003424:Crohn Disease / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009824:Ointments; D012871:Skin Diseases / Q000188:drug therapy*; D016559:Tacrolimus / Q000008:administration & dosage / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D009824:Ointments; D016559:Tacrolimus