Pimecrolimus 1% cream for oral erosive lichen planus: a 6-week randomized, double-blind, vehicle-controlled study with a 6-week open-label extension to assess efficacy and safety.
J Eur Acad Dermatol Venereol
; 25(9): 1061-7, 2011 Sep.
Article
em En
| MEDLINE
| ID: mdl-21175873
ABSTRACT
OBJECTIVE:
To assess the efficacy and safety of topical pimecrolimus 1% cream in the treatment of oral erosive lichen planus.DESIGN:
A 6-week randomized, double-blind, vehicle-controlled phase followed by a 6-week open-label phase.SETTING:
Outpatients of the Department of Dermatology, University of Utah. PATIENTS Twenty-one patients with oral erosive lichen planus were randomized and treated with either pimecrolimus 1% cream or vehicle cream. INTERVENTION Pimecrolimus 1% cream, or its vehicle, were applied twice daily for 6 weeks to each side of the mouth with a 2×2 inch gauze pad folded in half and placed directly on the erosive lesion. MAIN OUTCOMEMEASURES:
Efficacy was based on clinical evaluation of Investigator's Global Assessment (IGA) of the overall severity of the disease, erythema, measurement of the size of any target erosion in millimetres, and assessment of spontaneous pain. Blood levels of pimecrolimus were monitored in all subjects on day 0 and repeated on day 7.RESULTS:
Pimecrolimus 1% cream was superior to vehicle cream in reducing mean IGA, pain, and erosion size. For the vehicle group that entered the open-label phase, pimecrolimus 1% cream improved the mean IGA, pain, erosion size, and erythema. Pimecrolimus levels were detected in nine out of 10 of the pimecrolimus-treated subjects. These levels were consistently low. The pimecrolimus cream was well-tolerated. No clinically relevant, drug-related adverse events were reported.CONCLUSION:
Pimecrolimus 1% cream was superior to vehicle in reducing pain, erythema, decreasing erosion size, and improving overall severity of disease when compared with vehicle treatment.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Tacrolimo
/
Líquen Plano Bucal
/
Fármacos Dermatológicos
Idioma:
En
Ano de publicação:
2011
Tipo de documento:
Article