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 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. Objectives The aim of the present study was to evaluate efficacy and compliance of new lipid microspheres loaded with 0Æ025% 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. 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 and 33 females; mean age 61Æ1 years (± 12Æ3 SD; range 25–82)] were treated (17 with formulation A and 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 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, v 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 ¼ 0Æ02). 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 0Æ025% in OLP therapy.
Lingua originaleEnglish
pagine (da-a)984-990
Numero di pagine7
RivistaBritish Journal of Dermatology
Volume150
Stato di pubblicazionePublished - 2004

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Clobetasol
Oral Lichen Planus
Ointments
Microspheres
Clinical Trials
Lipids
Compliance
Phase IV Clinical Trials
Students
Drug Compounding
Patient Dropouts
Therapeutics
Drug Delivery Systems
Patient Compliance
Nonparametric Statistics
Pain

All Science Journal Classification (ASJC) codes

  • Dermatology

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@article{6d8d20cc0dca4cd2a7d6739649d62b8d,
title = "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,",
abstract = "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. Objectives The aim of the present study was to evaluate efficacy and compliance of new lipid microspheres loaded with 0{\AE}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. 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 and 33 females; mean age 61{\AE}1 years (± 12{\AE}3 SD; range 25–82)] were treated (17 with formulation A and 28 with formulation B, matched for gender and age; P > 0{\AE}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, v 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 ¼ 0{\AE}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{\AE}025{\%} in OLP therapy.",
author = "{De Caro}, Viviana and Giuseppina Campisi and Giulia Giandalia",
year = "2004",
language = "English",
volume = "150",
pages = "984--990",
journal = "British Journal of Dermatology",
issn = "0007-0963",
publisher = "Wiley-Blackwell",

}

TY - JOUR

T1 - 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,

AU - De Caro, Viviana

AU - Campisi, Giuseppina

AU - Giandalia, Giulia

PY - 2004

Y1 - 2004

N2 - 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. Objectives The aim of the present study was to evaluate efficacy and compliance of new lipid microspheres loaded with 0Æ025% 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. 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 and 33 females; mean age 61Æ1 years (± 12Æ3 SD; range 25–82)] were treated (17 with formulation A and 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 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, v 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 ¼ 0Æ02). 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 0Æ025% in OLP therapy.

AB - 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. Objectives The aim of the present study was to evaluate efficacy and compliance of new lipid microspheres loaded with 0Æ025% 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. 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 and 33 females; mean age 61Æ1 years (± 12Æ3 SD; range 25–82)] were treated (17 with formulation A and 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 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, v 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 ¼ 0Æ02). 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 0Æ025% in OLP therapy.

UR - http://hdl.handle.net/10447/30486

M3 - Article

VL - 150

SP - 984

EP - 990

JO - British Journal of Dermatology

JF - British Journal of Dermatology

SN - 0007-0963

ER -