Tacrolimus powder in Orabase 0.1% for the treatment of oral lichen planus and oral lichenoid lesions: an open clinical trial.
OBJECTIVE
The aim of our study was to evaluate the clinical efficacy and safety profile of a novel compound, Tacrolimus powder in Orabase 0.1% in patients with LP and LL.


METHODS
Seven patients with LP and 3 with LL were asked to participate. All patients received a 1 week treatment of Fluconazole, prior to entering the study, and on follow up visit were provided with a 15 g container of the study medication. Patients were asked to treat the most symptomatic site, three times a day for two weeks.


RESULTS
Disease control (signs) was achieved in most patients by the end of two weeks (from 1.58 to 0.55); all patients experienced a high degree of discomfort (pain) at baseline, which dropped quickly by the end of the second week of treatment (from 1.95 to 0.45); none developed yeast during the course of treatment. Recurrent headaches were reported by one patient with erosive LP, and transient burning by a patient with reticular LP.


CONCLUSIONS
Tacrolimus powder in Orabase 0.1% appears to have a relatively safe profile, and represents a likely alternative to topical steroids in the treatment of LP and LL, especially in those at risk for oral candidiasis.
Lozada-Nur
Francina I
FI
Department of OroFacial Science, Division of Oral Medicine, Oral Pathology, Oral Radiology, University of California, San Francisco, CA 94143-0422, USA. Lozada-Nur@ucsf.edu
Sroussi
Herve Y
HY
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage; D002266:Carboxymethylcellulose Sodium / Q000031:analogs & derivatives; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D017676:Lichen Planus, Oral / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D014677:Pharmaceutical Vehicles; D010865:Pilot Projects; D013256:Steroids / Q000008:administration & dosage; D016559:Tacrolimus / Q000008:administration & dosage*; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D007166:Immunosuppressive Agents; D014677:Pharmaceutical Vehicles; D013256:Steroids; C056627:Orabase; D002266:Carboxymethylcellulose Sodium; D016559:Tacrolimus