Treatment of oral erosive lichen planus with 1% pimecrolimus cream: a double-blind, randomized, prospective trial with measurement of pimecrolimus levels in the blood.

Abstract

OBJECTIVES:

To evaluate the efficacy of 1% pimecrolimus cream in treating oral erosive lichen planus and to assess its tolerance.

DESIGN:

Double-blind randomized trial with placebo control.

SETTING:

Outpatients of the Department of Dermatology, University Hospital of Nice, from December 21, 2004, to April 19, 2005.

PATIENTS:

Fourteen consecutive patients with oral erosive lichen planus confirmed by histological examination and with a clinical score superior to 3. Of the 14 patients, 2 did not meet the inclusion criteria and 12 were enrolled in the trial.

INTERVENTION:

The intervention was 1% pimecrolimus cream or its vehicle, which was applied on ulcerated lesions twice a day for 4 weeks.

MAIN OUTCOME MEASURES:

The efficacy of the treatment was quantified using a 12-point clinical score. The blood level of pimecrolimus was analyzed on days 0 (baseline), 14, and 28.

RESULTS:

In the placebo group, the mean score was 4.67 on day 0 vs 3.33 on day 28 (P = .22). In the pimecrolimus group, the mean score was 6.83 on day 0 vs 3.33 on day 28 (P = .04). In the pimecrolimus group, blood concentrations of pimecrolimus were always above the threshold (mean value, 2.84 ng/mL; extreme values, 0-6.19 ng/mL). Pimecrolimus cream was well tolerated, and only transient burning sensations were reported by some subjects. Each of the patients in the pimecrolimus group whose condition improved subsequently relapsed when assessed 1 month after treatment.

CONCLUSIONS:

The 1% pimecrolimus cream seems to be an effective and well-tolerated treatment for oral erosive lichen planus. The finding of systemic levels of pimecrolimus after mucosal applications necessitates long-term study because it seems that long-term application is required to maintain clinical improvement.

• Authors: Thierry Passeron, Jean-Philippe Lacour, Eric Fontas, Jean-Paul Ortonne
• Journal: Archives of dermatology (Arch Dermatol) Vol. 143 Issue 4 Pg. 472-6 (Apr 2007) ISSN: 0003-987X [Print] United States
• PMID: 17438179 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Calcineurin Inhibitors
• Ointments
• pimecrolimus
• Tacrolimus

Topics

• Aged
• Calcineurin Inhibitors
• Double-Blind Method
• Female
• Humans
• Lichen Planus, Oral (drug therapy, pathology)
• Male
• Middle Aged
• Ointments
• Tacrolimus (administration & dosage, adverse effects, analogs & derivatives, pharmacokinetics)