Efficacy of topical tacrolimus 0.3% in clobetasol propionate 0.05% ointment in therapy-resistant cutaneous lupus erythematosus: a cohort study

Clin Exp Dermatol. 2010 Jan;35(1):27-30. doi: 10.1111/j.1365-2230.2009.03351.x. Epub 2009 Jun 22.


Background: Despite a range of available topical and systemic therapies, treatment of cutaneous lupus erythematosus (CLE) can be challenging. Objectives. To evaluate the efficacy of a specially formulated preparation of tacrolimus 0.3% in clobetasol propionate 0.05% ointment (TCPO) in the treatment of CLE.

Methods: Case notes of 13 patients with treatment-resistant CLE (11 discoid LE, 1 systemic LE and 1 subacute cutaneous LE) who had used twice-daily TCPO (TCPO group) were reviewed. These were compared with five similar patients with resistant CLE who had been given 0.1% tacrolimus ointment alone (TO group).

Results: In the TCPO group (mean treatment duration 20 months, range 1-72), a good or excellent response was seen in five and six patients, respectively; one patient showed slight improvement. Telangiectasia and acne were observed in two patients. No systemic side-effects were noted. In the TO group (mean treatment duration 6 months, range 1-24), one patient showed good improvement and two showed slight improvement.

Conclusion: The results of our small retrospective study suggest that TCPO may be more effective than either 0.1% tacrolimus or clobetasol propionate 0.05% ointment monotherapy in the treatment of recalcitrant CLE. Randomized controlled trials are needed to confirm these preliminary findings.

MeSH terms

  • Administration, Topical
  • Adult
  • Aged
  • Clobetasol / administration & dosage*
  • Cohort Studies
  • Dermatologic Agents / administration & dosage*
  • Drug Administration Schedule
  • Drug Combinations
  • Female
  • Humans
  • Lupus Erythematosus, Cutaneous / drug therapy*
  • Male
  • Middle Aged
  • Retrospective Studies
  • Tacrolimus / administration & dosage*
  • Treatment Outcome
  • Young Adult


  • Dermatologic Agents
  • Drug Combinations
  • Clobetasol
  • Tacrolimus