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,

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Abstract

Background Topical application of clobetasol-17-propionate has been diffusely reported as anefficacious therapy in atrophic ⁄ erosive oral lichen planus (OLP), without exposing the patient tosystemic side-effects. However, prolonged contact and respective topical effects on the oral mucosashould be avoided.Objectives The aim of the present study was to evaluate efficacy and compliance of new lipidmicrospheres loaded with 0Æ025% of clobetasol propionate (formulation A) compared with acommonly 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.Patients and 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 and33 females; mean age 61Æ1 years (± 12Æ3 SD; range 25–82)] were treated (17 with formulation Aand 28 with formulation B, matched for gender and age; P > 0Æ2) with the same dosage regimen.At times T0, T1 and T2 we evaluated the following parameters: (i) pain score (by linear visualanalogue 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, v2, 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 abetter general trend for formulation A; a significant difference was registered for formulation A interms of a reduction in painful symptoms (parameter i) at time T2 (P ¼ 0Æ02).Conclusions Our results suggest that the new topical drug delivery system (formulation A) mayenhance, at least in terms of symptom remission and compliance, the effectiveness of clobetasolpropionate at a dose of 0Æ025% in OLP therapy.
Lingua originaleEnglish
pagine (da-a)984-990
Numero di pagine7
RivistaBritish Journal of Dermatology
Volume150
Stato di pubblicazionePublished - 2004

All Science Journal Classification (ASJC) codes

  • Dermatology

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