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

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.

Medical Management of Oral Lichen Planus: A Systematic Review

“…Among these studies, [4,8,9,27,36] did not present any significant difference in pain reduction. However, lower pain scores in the group that used microsphere formulation [10] & better response in betamethasone group [20] were shown.…”

“…The comparisons were: flucinoloneacetonide in an oral base 0.1% vs flucinoloneacetonide gel no.1 and the same orabase with flucinoloneacetonide gel no.2 [8], clobetasol (0.025%) in microspheres with clobetasol ointment (0.025%) [10], triamcinolone acetonide in mouth rinse vs intralesional triamcinolone acetonide injection [36]; two studies compared different steroids in different arms topical fluticasone propionate spray and betamethasone sodium phosphate mouthrinse [9]; betamethasone OMP and triamcinolone acetonide paste [20]; one trial [4] compared different steroids in the same arm (clobetasolorabase ointment and triamcinoloneacetonide ointment); one study [27] used the same steroid clobetasol ointment in different concentrations (0.05% vs 0.025%). Among these studies, [4,8,9,27,36] did not present any significant difference in pain reduction.…”

“…[18] all the participants received a systemic steroid, and in another study [28] the experimental intervention was compared with intralesional steroid. Of the 29 trials using steroid as an active intervention, clobetasol was used in nine trials [4,7,10,11,19,22,23,27,35], triamcinolone in ten trials [4,5,[13][14][15][16]20,28,31,36], flucinolone in two trials [6,8], dexamethasone in two trials [29,34], prednisolone in one trial [18], fluticasone in one trial [9] & betamethasone in two trials [9,20]. Systemic prednisolone was used in one trial [18].…”

“…Of the 35 RCTs, the randomisation methods used by some studies [3,7,9,20,21,[28][29][30] was random number tables, by few others [10,14,15,18,36] was block randomisation, and an automated system of assigning randomisation numbers was followed by few other trials [19,[22][23][24][25]27,31,34,35]. Passeron used draw lots method [17].…”

“…Clinical response was measured by eleven trials [6][7][8][9][10][14][15][16]21,27,30,31] using the clinical grading by Thongprasom 1992 consisting of a six-point ordinal scale, four trials [17,19,22,24] used a different clinical grading scale with scores 1 to 4. Tel Aviv San Francisco scale was used in one trial [32].…”