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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.
Br J Dermatol. 2004 May; 150(5):984-90.BJ

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 0.025% 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 61.1 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.

Authors+Show Affiliations

Department of Chemistry and Pharmaceutical Technologies, University of Palermo, Palermo, Italy. giucampisi@inwind.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase IV
Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

15149513

Citation

Campisi, G, et al. "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." The British Journal of Dermatology, vol. 150, no. 5, 2004, pp. 984-90.
Campisi G, Giandalia G, De Caro V, et al. 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. Br J Dermatol. 2004;150(5):984-90.
Campisi, G., Giandalia, G., De Caro, V., Di Liberto, C., Aricò, P., & Giannola, L. I. (2004). 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. The British Journal of Dermatology, 150(5), 984-90.
Campisi G, et al. 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. Br J Dermatol. 2004;150(5):984-90. PubMed PMID: 15149513.
* Article titles in AMA citation format should be in sentence-case
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 - Campisi,G, AU - Giandalia,G, AU - De Caro,V, AU - Di Liberto,C, AU - Aricò,P, AU - Giannola,L I, PY - 2004/5/20/pubmed PY - 2004/7/16/medline PY - 2004/5/20/entrez SP - 984 EP - 90 JF - The British journal of dermatology JO - Br. J. Dermatol. VL - 150 IS - 5 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 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. 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 61.1 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. SN - 0007-0963 UR - https://www.unboundmedicine.com/medline/citation/15149513/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_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&sid=nlm:pubmed&issn=0007-0963&date=2004&volume=150&issue=5&spage=984 DB - PRIME DP - Unbound Medicine ER -