A new delivery system of clobetasol-17-propionate (lipid-loaded microspheres 0.025%) compared with a conventional formulation (lipophilic ointment in a hydrophilic phase 0.025%) in topical treatment of atrophic/erosive oral lichen planus. A Phase IV, randomized, observer-blinded, parallel group clinical trial.
BACKGROUND
Topical application of clobetasol-17-propionate has been diffusely reported as an efficacious therapy in atrophic/erosive oral lichen planus (OLP), without exposing the patient to systemic side-effects. However, prolonged contact and respective topical effects on the oral mucosa should be avoided.


OBJECTIVE
The aim of the present study was to evaluate efficacy and compliance of new lipid microspheres loaded with 0.025% of clobetasol propionate (formulation A) compared with a commonly used formulation (a sort of dispersion of a lipophilic ointment in a hydrophilic phase) with the same amount of drug (formulation B) in the topical treatment of OLP.


METHODS
Fifty patients with symptomatic OLP were enrolled in a controlled single-blind phase IV clinical trial. After a dropout of five patients, a total of 45 patients [12 males and 33 females; mean age 61.1 years (+/- 12.3 SD; range 25-82)] were treated (17 with formulation A and 28 with formulation B, matched for gender and age; P > 0.2) with the same dosage regimen. At times T0, T1 and T2 we evaluated the following parameters: (i) pain score (by linear visual analogue scale; 0-100); (ii) clinical score; (iii) clinical resolution; and (iv) patient compliance. Statistical analysis was calculated using S-Plus 4.0 and SPSS 9.0 (Student's t-test, chi(2), Kolmogorov-Smirnow, Friedman, Student-Newman-Keuls, Mann-Whitney U-test and Spearman tests).


RESULTS
Both formulations were found to be similar for parameters ii, iii and iv, although with a better general trend for formulation A; a significant difference was registered for formulation A in terms of a reduction in painful symptoms (parameter i) at time T2 (P = 0.02).


CONCLUSIONS
Our results suggest that the new topical drug delivery system (formulation A) may enhance, at least in terms of symptom remission and compliance, the effectiveness of clobetasol propionate at a dose of 0.025% in OLP therapy.
Campisi
G
G
Department of Chemistry and Pharmaceutical Technologies, University of Palermo, Palermo, Italy. giucampisi@inwind.it
Giandalia
G
G
De Caro
V
V
Di Liberto
C
C
Aricò
P
P
Giannola
L I
LI
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D002626:Chemistry, Pharmaceutical; D002990:Clobetasol / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D016503:Drug Delivery Systems; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D017676:Lichen Planus, Oral / Q000188:drug therapy*; D008055:Lipids; D008297:Male; D008863:Microspheres; D008875:Middle Aged; D009824:Ointments; D010349:Patient Compliance; D016037:Single-Blind Method
D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids; D008055:Lipids; D009824:Ointments; D002990:Clobetasol