Oral Erosive Lichen Planus Clinical Trial
Official title:
Phase 2 Study of the Treatment of Oral Erosive Lichen Planus With 1% Pimecrolimus Cream: a Double Blind Randomized Prospective Trial With Measurement of Pimecrolimus Levels in the Blood
Background and hypothesis. Oral erosive lichen planus (OELP) is a severe form of mucosal
lichen planus. Lesions often induce intense pain and limit feeding. Its course is chronic
with flares and spontaneous remissions are rare. Treatment is difficult: topical steroids
are usually used first but antimalarials, oral retinoids, systemic steroids,
immunosuppressive drugs and even extracorporeal photochemotherapy can be necessary for
treating severe forms. The need for novel therapies with less morbidity is obvious.
Calcineurin inhibitors have a theoretical interest in treating OELP: this has been
emphasized by several open studies performed with topical tacrolimus. The effectiveness of
1% pimecrolimus cream has been suggested by a few case reports and by one recent comparative
study which confirmed the potential interest of topical pimecrolimus in treating OELP. The
absorption of pimecrolimus through human mucosa is still unknown. Its application on
ulcerative lesions such as OELP ones, could lead to significant systemic levels of the
molecule.
Objective: To evaluate the efficacy of 1% pimecrolimus cream in treating oral erosive lichen
planus (OELP) and to assess its tolerance.
Background and hypothesis. Oral erosive lichen planus (OELP) is a severe form of mucosal
lichen planus. Lesions often induce intense pain and limit feeding. Its course is chronic
with flares and spontaneous remissions are rare. Treatment is difficult: topical steroids
are usually used first but antimalarials, oral retinoids, systemic steroids,
immunosuppressive drugs and even extracorporeal photochemotherapy can be necessary for
treating severe forms. The need for novel therapies with less morbidity is obvious.
Calcineurin inhibitors have a theoretical interest in treating OELP: this has been
emphasized by several open studies performed with topical tacrolimus. The effectiveness of
1% pimecrolimus cream has been suggested by a few case reports and by one recent comparative
study which confirmed the potential interest of topical pimecrolimus in treating OELP. The
absorption of pimecrolimus through human mucosa is still unknown. Its application on
ulcerative lesions such as OELP ones, could lead to significant systemic levels of the
molecule.
Objective: To evaluate the efficacy of 1% pimecrolimus cream in treating oral erosive lichen
planus (OELP) and to assess its tolerance.
Design: Double blind randomized trial with placebo control.
Settings: Outpatients of the Department of Dermatology of the University hospital of Nice,
France.
Patients: Fourteen consecutive patients with OELP confirmed by histological examination and
with a clinical score superior to 3. 1% pimecrolimus cream or its vehicle were applied on
ulcerated lesions twice a day for 4 weeks.
Main outcome measures; the efficacy of the treatment was quantified using a 12 points
clinical score. Blood level of pimecrolimus was analyzed at D0, D14 and D28.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment