Treatment of oral erosive lichen planus with 1% pimecrolimus cream: a double-blind, randomized, prospective trial with measurement of pimecrolimus levels in the blood. Passeron, T., Lacour, J., P., Fontas, E., & Ortonne, J., P. Arch Dermatol, 143(4):472-476, 2007.
Treatment of oral erosive lichen planus with 1% pimecrolimus cream: a double-blind, randomized, prospective trial with measurement of pimecrolimus levels in the blood [link]Website  abstract   bibtex   
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.
@article{
 title = {Treatment of oral erosive lichen planus with 1% pimecrolimus cream: a double-blind, randomized, prospective trial with measurement of pimecrolimus levels in the blood},
 type = {article},
 year = {2007},
 identifiers = {[object Object]},
 keywords = {Aged,Calcineurin/antagonists & inhibitors,Double-Blind Method,Female,Humans,Lichen Planus, Oral/*drug therapy/pathology,Male,Middle Aged,Ointments,Tacrolimus/administration & dosage/adverse effects,derivatives/pharmacokinetics},
 pages = {472-476},
 volume = {143},
 websites = {http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=17438179},
 edition = {2007/04/18},
 id = {6212a58d-30ca-345e-a55f-97fb004bbdae},
 created = {2017-06-19T13:43:37.815Z},
 file_attached = {false},
 profile_id = {de68dde1-2ff3-3a4e-a214-ef424d0c7646},
 group_id = {b2078731-0913-33b9-8902-a53629a24e83},
 last_modified = {2017-06-19T13:43:37.963Z},
 read = {false},
 starred = {false},
 authored = {false},
 confirmed = {true},
 hidden = {false},
 source_type = {Journal Article},
 language = {eng},
 notes = {<m:note>Passeron, Thierry<m:linebreak/>Lacour, Jean-Philippe<m:linebreak/>Fontas, Eric<m:linebreak/>Ortonne, Jean-Paul<m:linebreak/>Randomized Controlled Trial<m:linebreak/>Research Support, Non-U.S. Gov't<m:linebreak/>United States<m:linebreak/>Archives of dermatology<m:linebreak/>143/4/472<m:linebreak/>Arch Dermatol. 2007 Apr;143(4):472-6.</m:note>},
 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.},
 bibtype = {article},
 author = {Passeron, T and Lacour, J P and Fontas, E and Ortonne, J P},
 journal = {Arch Dermatol},
 number = {4}
}
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