Efficacy of topical tacrolimus 0.1% in active plaque morphea: randomized, double-blind, emollient-controlled pilot study.
BACKGROUND
Tacrolimus, a calcineurin inhibitor, is an immunomodulating and anti-inflammatory drug that inhibits T-cell activation and production of cytokines. The elevated level of cytokines in morphea causes fibroblast proliferation and subsequent overproduction of collagen. Theoretically, tacrolimus could inhibit the pathophysiologic process of morphea.


OBJECTIVE
To assess whether tacrolimus 0.1% ointment is an effective treatment for active plaque morphea in a double-blind, placebo (petroleum emollient)-controlled pilot study.


METHODS
Ten patients with active plaque morphea were included. All patients were treated with tacrolimus 0.1% ointment and with an emollient (petrolatum) on two selected morphea plaques, applied twice daily for 12 weeks. Initial and final assessment included surface area measurements, photography, durometer scores, and clinical feature scores. Adverse reactions were recorded.


RESULTS
The scleroderma plaques treated with topical tacrolimus 0.1% improved, resulting in a significant reduction in durometer and clinical feature scores. Overall, a significant difference could be found between topical tacrolimus and petrolatum with regard to durometer score (p < 0.005) and the clinical feature score (p = 0.019).


CONCLUSIONS
In this first double-blind, placebo-controlled pilot study comparing tacrolimus 0.1% ointment with petrolatum in active plaque morphea, tacrolimus 0.1% ointment was shown to be an effective treatment for this condition.
Department of Dermatology, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands. i.kroft@zgt.nl
Elisabeth B M
EB
Kroft
Tamara J
TJ
Groeneveld
Marieke M B
MM
Seyger
Elke M G J
EM
de Jong
D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004643:Emollients / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009824:Ointments / Q000627:therapeutic use; D010577:Petrolatum / Q000627:therapeutic use; D010865:Pilot Projects; D012594:Scleroderma, Localized / Q000175:diagnosis / Q000188:drug therapy*; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
D004643:Emollients; D007166:Immunosuppressive Agents; D009824:Ointments; D010577:Petrolatum; D016559:Tacrolimus