This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on ISI (7)  • Contact me when this article is cited  Related Content  • Related articles  • Similar articles in this journal  Topic Collections  • Dentistry/ Oral Medicine  • Dermatologic Disorders  • Randomized Controlled Trial  • Dermatologic Disorders, Other  • Drug Therapy  • Drug Therapy, Other  • Alert me on articles by topic  Social Bookmarking   What's this?

A Double-blind, Randomized, Prospective Trial With Measurement of Pimecrolimus Levels in the Blood

Thierry Passeron, MD; Jean-Philippe Lacour, MD; Eric Fontas, MD; Jean-Paul Ortonne, MD

Arch Dermatol. 2007;143(4):472-476.

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.

Trial Registration  clinicaltrials.gov Identifier: NCT00321750

Author Affiliations: Department of Dermatology, Archet 2 Hospital (Drs Passeron, Lacour, and Ortonne), and Department of Public Health, Archet 1 Hospital (Dr Fontas), University of Nice, Nice, France.

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati     What's this?

RELATED ARTICLES

A Randomized, Double-blind, Placebo-Controlled Trial of Pentoxifylline for the Treatment of Recurrent Aphthous Stomatitis
Martin H. Thornhill, Lorena Baccaglini, Elizabeth Theaker, and Michael N. Pemberton
Arch Dermatol. 2007;143(4):463-470.
ABSTRACT | FULL TEXT  

Oral Lichen Planus: A Case Series With Emphasis on Therapy
Dorothea C. Torti, Joseph L. Jorizzo, and Martha Ann McCarty
Arch Dermatol. 2007;143(4):511-515.
ABSTRACT | FULL TEXT  

New and Old Therapeutics for Oral Ulcerations
Alison Bruce and Roy S. Rogers, III
Arch Dermatol. 2007;143(4):519-523.
EXTRACT | FULL TEXT  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

New and Old Therapeutics for Oral Ulcerations
Bruce and Rogers
Arch Dermatol 2007;143:519-523.
FULL TEXT