Proactive treatment of adult facial seborrhoeic dermatitis with 0.1% tacrolimus ointment: randomized, double-blind, vehicle-controlled, multi-centre trial

Acta Derm Venereol. 2013 Sep 4;93(5):557-61. doi: 10.2340/00015555-1532.

Abstract

The effectiveness of intermittent topical tacrolimus to prevent relapse in patients with stabilized facial seborrhoeic dermatitis has not been evaluated. The aim of this study was to determine whether proactive use of 0.1% tacrolimus ointment can keep adult facial seborrhoeic dermatitis in remission. A total of 75 patients who had stabilized facial seborrhoeic dermatitis after 2 weeks' (open-label induction) treatment with 0.1% tacrolimus were randomized in a double-blind fashion to treatment with 0.1% tacrolimus once a week, twice a week, or vehicle twice a week, for 10 weeks (maintenance). Significant improvement in erythema, scaling and pruritus compared with baseline was maintained during the maintenance phase in both tacrolimus groups, but not in the vehicle group. The mean recurrence rate according to global assessment was significantly higher in the tacrolimus once-weekly group than in the twice-weekly group. In conclusion, twice-weekly treatment with 0.1% tacrolimus ointment had superior effects in keeping facial seborrhoeic dermatitis in remission.

Trial registration: ClinicalTrials.gov NCT01591070.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Cutaneous
  • Adult
  • Aged
  • Chi-Square Distribution
  • Dermatitis, Seborrheic / diagnosis
  • Dermatitis, Seborrheic / drug therapy*
  • Dermatologic Agents / administration & dosage*
  • Dermatologic Agents / adverse effects
  • Double-Blind Method
  • Drug Administration Schedule
  • Facial Dermatoses / diagnosis
  • Facial Dermatoses / drug therapy*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Ointments
  • Remission Induction
  • Republic of Korea
  • Secondary Prevention
  • Tacrolimus / administration & dosage*
  • Tacrolimus / adverse effects
  • Time Factors
  • Treatment Outcome

Substances

  • Dermatologic Agents
  • Ointments
  • Tacrolimus

Associated data

  • ClinicalTrials.gov/NCT01591070