Pimecrolimus 1% cream versus betamethasone 17-valerate 0.1% cream in the treatment of facial discoid lupus erythematosus: a double-blind, randomized pilot study

Clin Exp Dermatol. 2009 Oct;34(7):776-80. doi: 10.1111/j.1365-2230.2008.03138.x. Epub 2009 May 18.


Background: Discoid lupus erythematosus (DLE) is commonly treated with topical agents, the most important of which are glucocorticosteroids. However, prolonged use of these agents, especially on sensitive areas such as the face, may result in side-effects (e.g. atrophy and telangiectases) by altering collagen synthesis. Therefore, alternative treatments are needed for these patients.

Aim: To investigate and compare the efficacy of topical pimecrolimus 1% cream and topical betamethasone 17-valerate 0.1% cream on facial lesions of DLE.

Methods: This was a randomized double-blind pilot study, performed in outpatient clinics of two major referral hospitals. Ten patients aged 20-53 years with moderate to severe DLE of the face were randomized into two groups for 8 weeks of treatment and 8 weeks of follow-up after treatment. In this double-blind study, one group applied pimecrolimus 1% cream twice daily and the other group applied betamethasone valerate 0.1% cream twice daily to facial lesions. Efficacy end-points included a combined score based on evaluation of erythema, infiltration and presence of scale.

Results: Efficacy end-points showed significant improvement in both groups. A decrease of 86% and 73% in clinical severity scores was obtained for pimecrolimus and betamethasone, respectively (P = 0.043). There was no significant difference between the two groups in terms of efficacy (P = 0.1). No adverse effect was found at the end of the 8-week trial in any of our patients.

Conclusions: The efficacy of pimecrolimus 1% cream is comparable with that of betamethasone valerate 0.1% cream in treating facial DLE.

Publication types

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

MeSH terms

  • Administration, Cutaneous
  • Adult
  • Betamethasone Valerate / therapeutic use*
  • Double-Blind Method
  • Facial Dermatoses / drug therapy*
  • Facial Dermatoses / pathology
  • Female
  • Glucocorticoids / therapeutic use*
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Lupus Erythematosus, Discoid / drug therapy*
  • Lupus Erythematosus, Discoid / pathology
  • Male
  • Middle Aged
  • Pilot Projects
  • Severity of Illness Index
  • Tacrolimus / analogs & derivatives*
  • Tacrolimus / therapeutic use
  • Treatment Outcome
  • Young Adult


  • Glucocorticoids
  • Immunosuppressive Agents
  • pimecrolimus
  • Betamethasone Valerate
  • Tacrolimus