A randomized controlled trial to compare steroid with cyclosporine for the topical treatment of oral lichen planus. Photochemotherapy of oral lichen planus. A controlled study. The efficacy of topical intralesional BCG-PSN injection in the treatment of erosive oral lichen planus: a randomized controlled trial. Efficacy of purslane in the treatment of oral lichen planus. Ignatia in the treatment of oral lichen planus. A comparison of treatment of oral lichen planus with topical tacrolimus and triamcinolone acetonide ointment. The efficacy of topical hyaluronic acid in the management of oral lichen planus. Pimecrolimus cream 1% in erosive oral lichen planus--a prospective randomized double-blind vehicle-controlled study. Betamethasone oral mini-pulse therapy compared with topical triamcinolone acetonide (0.1%) paste in oral lichen planus: A randomized comparative study. Efficacy of topical Aloe vera in patients with oral lichen planus: a randomized double-blind study. The effectiveness of 1% pimecrolimus cream in the treatment of oral erosive lichen planus. Fluocinonide in an adhesive base for treatment of oral lichen planus. A double-blind, placebo-controlled clinical study. The efficacy of aloe vera gel in the treatment of oral lichen planus: a randomized controlled trial. Comparative effect of tacrolimus 0.1% ointment and clobetasol 0.05% ointment in patients with oral lichen planus. Ciclosporin vs. clobetasol in the topical management of atrophic and erosive oral lichen planus: a double-blind, randomized controlled trial. Fluticasone propionate spray and betamethasone sodium phosphate mouthrinse: a randomized crossover study for the treatment of symptomatic oral lichen planus. Topical clobetasol in the treatment of atrophic-erosive oral lichen planus: a randomized controlled trial to compare two preparations with different concentrations. Miconazole as adjuvant therapy for oral lichen planus: a double-blind randomized controlled trial. A randomized, placebo-controlled, double-blind clinical trial of curcuminoids in oral lichen planus. Effect of topical cyclosporine rinse on oral lichen planus. A double-blind analysis. Treatment of oral erosive lichen planus with 1% pimecrolimus cream: a double-blind, randomized, prospective trial with measurement of pimecrolimus levels in the blood. 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. Randomized trial of pimecrolimus cream versus triamcinolone acetonide paste in the treatment of oral lichen planus.
To compare the effectiveness of cyclosporine solution versus triamcinolone acetonide in orabase in the treatment of oral lichen planus (OLP) in reducing signs and symptoms.
                One hundred thirty-nine biopsy-proven OLP patients were randomly assigned to cyclosporine (68) or steroid (71) applied onto the target lesion and affected areas. Assessments were at weeks 0, 2, 4, 8 by clinical scoring and grid measurement of the target lesion (reticulation, erythema, ulceration). Patients ranked severity of pain and burning sensation using visual analog scales.
                Although clinical response, pain, burning sensation, area of reticulation, erythema, and ulceration at week 4 were all worse in patients receiving cyclosporine than in those receiving steroid, the differences were not statistically significant. Large patient-to-patient variability was evident over the observation period, with little evidence of marked changes in levels over time in both treatment groups.
                Topical cyclosporine appears no more effective than steroid in the treatment of oral lichen planus. Photochemotherapy with 8-methoxypsoralen and long-wave ultraviolet light (PUVA) has become a useful alternative in dermatologic therapy. PUVA therapy has been successfully used in the treatment of severe psoriasis and cutaneous lichen planus. The aim of this investigation was to use PUVA in the treatment of oral lichen planus (OLP). Eighteen patients with long-standing, bilateral, and severe OLP of the buccal mucosa participated in the investigation. A dose of 0.6 mg/kg 8-methoxypsoralen was administered orally 2 hours before long-wave ultraviolet light irradiation was done. The patients were randomly assigned to treatment of the left or right side of the buccal mucosa. The irradiation therapy was given 12 times at intervals of 2 to 3 days, and the patients received a total average dosage of 16.5 J/cm2. The results showed that 13 treated sites compared with six control sites responded significantly favorable to PUVA therapy. Two patients dropped out because of side effects that were similar to those seen after whole-body irradiation PUVA treatment. The follow up times was 12 months. The conclusion of this study is that PUVA seems to be effective in the treatment of OLP and should be considered in severe cases of OLP. Nowadays, it has been widely accepted that the local cell-mediated immunologic disorders may play an important role in the pathogenesis of oral lichen planus (OLP). Therefore, we sieved out polysaccharide nucleic acid fraction of bacillus Calmette-Guerin (BCG-PSN) from various immunomodulators to evaluate the short-term therapeutic efficacy and clinical safety of intralesional BCG-PSN injection for erosive OLP.
                A total of 56 OLP patients were randomly assigned to receive either intralesional injection of 0.5 ml BCG-PSN every other day (31 of 56) or 10 mg triamcinolone acetonide (TA, a positive-controlled group, 25 of 56) every week for 2 weeks. After the cessation of treatment, those cured from erosion were followed up for 3 months. Another two researchers measured erosive areas and recorded visual analog scale (VAS) scores both at the start and the end of the treatment. We also registered adverse reactions and the recurrence intervals.
                After 2-week treatment, 27 of 31 BCG-PSN-treated patients (87.1%) and 22 of 25 TA-treated patients (88.0%) healed. There were no statistical differences between the two groups in erosive areas (27.86 +/- 27.97 vs. 25.68 +/- 34.65, P = 0.801) and VAS scores (2.45 +/- 1.64 vs. 2.40 +/- 1.38, P = 0.946). Three of 31 BCG-PSN-treated patients (9.7%) vs. 2 of 25 TA-treated patients (8.0%) experienced the swelling or burning sensation (P = 0.827). A total of 49 of 56 patients were followed up. There were no statistical differences in the recurrence rates (33.3% vs. 45.5%, P = 0.386) and intervals (80.89 +/- 26.83 vs. 73.48 +/- 28.11, P = 0.419).
                Topical intralesional BCG-PSN injection is as effective as TA for erosive OLP, which suggests that topical intralesional BCG-PSN injection can be a promising therapeutic alternative for erosive OLP, especially for those insensitive, or even resistant, to glucocorticoids. This study evaluated the effectiveness of antioxidant-rich purslane in the treatment of oral lichen planus (OLP). A total of 37 biopsy-proven symptomatic OLP patients were selected for this randomized double-blind placebo-controlled trial. All subjects were divided into two groups to receive purslane (n = 20) or placebo (n = 17) for 3 months. Assessments were made at baseline, after 2 weeks and each month for 6 months, based on the visual analog scale (VAS) and clinical improvement including lesion type and size. Approximately 83% of the purslane patients showed partial to complete clinical improvement but 17% had no response. In the placebo group 17% experienced partial improvement, 73% did not respond and 10% showed worsening. According to VAS scores, a partial to complete response was observed in all purslane-treated patients, while 71%, 15% and 14% of the controls demonstrated partial response, no response and worsening of the symptoms, respectively. A significant decrease in VAS scores was seen at the end of the study period (p < 0.001). No serious side-effects occurred in either of the groups. According to our findings purslane is clinically effective in the treatment of OLP. Considering the lack of side-effects during the study period, it may be a favorable alternative treatment for OLP.
                (c) 2009 John Wiley & Sons, Ltd. To evaluate the effectiveness of Ignatia homeopathic 30C in management of oral lichen planus (OLP).
                In this single blind randomized control clinical trial, 30 consecutive patients with oral lesions consistent clinically and histologically with erosive and/or atrophic OLP were recruited. The patients were randomly divided into two groups to receive Ignatia or placebo. They were treated for 4 months.
                Mean lesion sizes and mean pain measures differed between control and treatment groups favouring Ignatia (p<0.05).
                Our results suggest that Ignatia has a beneficial effect in treatment of OLP in selected patients. Treatment of symptomatic oral lichen planus remains a challenging problem. This study compared the efficacy of topical tacrolimus ointment with triamcinolone acetonide ointment in patients with oral lichen planus. Twenty patients (group I) were treated with topical tacrolimus 0.1% ointment 4 times daily, and 20 (group II) were treated with triamcinolone acetonide 0.1% ointment 4 times daily. The clinical effect was graded after 6 weeks. In group I, 6 patients healed, 12 showed improvement and 2 showed no improvement. In group II, 2 patients healed, 7 improved and 11 showed no improvement. The most commonly reported side-effect in both groups was temporary burning or stinging at the site of application. Unfortunately, oral lesions recurred within 3-9 weeks of cessation of treatment in 13 of the 18 patients who had initially shown an improvement or were healed in group I and in 7 of the 9 patients in group II. Topical tacrolimus 0.1% ointment induced a better initial therapeutic response than triamcinolone acetonide 0.1% ointment. However, relapses occurred frequently within 3-9 weeks of the cessation of treatment. The aim of this study was to evaluate the efficacy of a topical hyaluronic acid (HA) gel preparation (0.2%) in the management of oral lichen planus (OLP).
                A total of 124 patients with erosive OLP participated in a randomized, placebo-controlled, double-blind trial to evaluate the efficacy of a topical HA preparation. Outcome measures included soreness relief following immediate application, oral function and size of erosive/ulcerative area. Patients were medicated for 28 days and completed a log diary recording oral function and soreness scores.
                Application of topical HA produced a significant reduction (P < 0.05) in soreness scores when compared with placebo for up to 4 h post-application. There was no difference between treatment groups (P > 0.05) with respect to oral function. Patients treated with 0.2% HA showed a significant reduction (P < 0.05) in the size of the erosive/ulcerated area after 28 days of treatment when compared with baseline. There was no significant difference in changes in ulcerative areas between treatment groups.
                Topical HA (0.2%) does appear to be of some benefit in the management of erosive lichen planus providing efficacy for up to 4 h after administration. Very frequent applications should be considered to obtain a more significant clinical benefit. Topical HA gel may be a useful addition to the treatment option for OLP. Erosive oral lichen planus (EOLP) is a T-cell mediated inflammatory disease leading to severe pain and impairment. As current therapies are of limited efficacy, application of calcineurin inhibitors is considered to be a potential option.
                To investigate the efficacy of pimecrolimus cream 1% (Elidel) compared with vehicle cream in the treatment of EOLP.
                Twenty patients were enrolled in a prospective, double-blind, randomized, vehicle-controlled trial and assigned to either pimecrolimus or vehicle group. Study medication was applied for 30 days followed by 30 days of observation without therapy. In case of unresponsiveness, treatment was continued for 30 days with open-label pimecrolimus. EOLP was monitored on days 0, 30 and 60. Safety was assessed by patient documentation, measurement of pimecrolimus levels and blood counts.
                Within 30 days erosions cleared completely in seven of 10 patients treated with pimecrolimus and in two of 10 patients treated with vehicle. The clinical EOLP 'composite score' including mucosal erosions and pain sensation was significantly reduced in the pimecrolimus-treated group compared with vehicle (P = 0.025). In the three of 10 patients not responding to pimecrolimus, EOLP cleared after an additional 30 days of treatment with pimecrolimus. Following termination of the therapy, sustained remission of EOLP was detected in 83% of patients demonstrating long-lasting effects of pimecrolimus treatment. No severe adverse events were observed. In five patients pimecrolimus blood levels were detected, all of which stayed below 4 ng mL(-1).
                Pimecrolimus cream 1% effectively treats EOLP with long-lasting therapeutic effects and is therefore a promising therapeutic option for EOLP. Betamethasone oral mini-pulse (OMP) therapy has been used effectively and safely in vitiligo, alopecia areata, and lichen planus.
                We sought to evaluate the efficacy and safety of betamethasone OMP in patients with symptomatic moderate to severe oral lichen planus and to compare it with topical triamcinolone acetonide.
                In all, 49 patients with moderate to severe oral lichen planus were randomly allocated to receive either OMP comprising 5 mg of betamethasone orally on 2 consecutive days per week (group A) or triamcinolone acetonide (0.1%) paste application thrice daily (group B), for 3 months followed by stepwise tapering during the next 3 months. Treatment response was assessed by the change in the score, which was based on the number of sites involved and the area affected. The changes in the symptoms and side effects were also recorded. Patients were followed up after treatment for 3 months to look for relapse.
                In all, 23 of 25 patients in group A and 23 of 24 patients in group B completed the study. Good to excellent response was seen in 17 of 25 (68.0%) patients in group A as compared with 16 of 24 (66.0%) in group B at 6 months. Symptom-free state was achieved in 13 of 25 (52%) patients in group A and 12 of 24 (50%) in group B. The difference in the mean scores within each group was statistically significant from the fourth week onward in group A and eighth week onward in group B, whereas in patients with erosive disease it was second and twelfth week onward, respectively. The difference in the treatment response between the two groups was statistically significant only at week 24 when reduction in severity score was more in triamcinolone group. Side effects were seen in 14 (56%) patients in group A and 6 (25%) patients in group B, which were mild and reversible. Relapse occurred in 9 of 23 (39.1%) patients in group A after 13.78 +/- 6.96 weeks as compared with 5 of 23 (21.7%) in group B after 19.20 +/- 1.79 weeks.
                The study was not blinded and the change in the quality of life with treatment was not measured.
                Betamethasone OMP improves the clinical outcome in patients with moderate to severe oral lichen planus. When compared with topical triamcinolone acetonide it is equally effective but the response is earlier, especially in erosive disease. It may be a useful and convenient alternative either as a monotherapy or to achieve rapid symptomatic relief during periods of exacerbations. Different treatments have been used in application to symptomatic oral lichen planus (OLP), with variable results, perhaps caused by the refractory nature of the disease. The objective of this study was to evaluate the efficacy of the topical application of aloe vera (AV) in OLP compared with placebo.
                A total of 64 patients with OLP were randomized in a double-blind study to either AV (32 patients) or placebo (32 patients), at a dose of 0.4 ml (70% concentration) three times a day. A Visual Analog Scale was used for rating pain, with the application of a clinical scale for scoring the lesions, the Oral Health Impact Profile 49 (OHIP-49), and the Hospital Anxiety-Depression (HAD) scale. The patients were evaluated after 6 and 12 weeks.
                No statistically significant differences were recorded between both groups in relation to pain after 6 and 12 weeks. In the AV group, complete pain remission was achieved in 31.2% of the cases after 6 weeks, and in 61% after 12 weeks. In the placebo group, these percentages were 17.2% and 41.6%, respectively. There were no adverse effects in any of the groups. In relation to quality of life, significant differences were observed between the two groups in the psychological disability domain and total OHIP-49 score.
                The topical application of AV improves the total quality of life score in patients with OLP.
                © 2010 John Wiley & Sons A/S. The purpose of this study was to evaluate the efficacy, relative safety, and tolerability of 1% pimecrolimus cream in the treatment of oral erosive lichen planus (OELP).
                Twenty patients with OELP were randomized into equal groups; group 1 applied 1% pimecrolimus cream twice daily to their oral lesions for 4 weeks, whereas group 2 applied a placebo cream. Photographs of the lesions were taken and analyzed for areas of ulceration, erythema, and reticulation. Discomfort scores were also assessed with a visual analogue scale (VAS). Blood samples were taken at baseline and at study completion; a complete blood count with differential and comprehensive metabolic panel was ordered. The Wilcoxon signed rank test was used.
                The experimental group showed a decrease in ulceration (alpha = 0.068) and erythema (alpha = 0.005) at the mid-point with continued reduction of erythema at the final (alpha = 0.075) time measurement. The control group demonstrated an increase in reticulation at the mid-point (alpha = 0.017) and final (alpha = 0.007) time measurement. The VAS scores for the experimental group decreased during the study (alpha = 0.022). Blood levels were within the normal range.
                The OELP lesion size in the 1% pimecrolimus group decreased and the pimecrolimus cream was found to significantly reduce the patient's pain scores. Further study of 1% pimecrolimus as therapy for OELP is warranted since it was shown to be effective, relatively safe, and well tolerated by patients within the limits of this short-term study. Patients with symptomatic oral lichen planus frequently require therapy to reduce signs and symptoms. For this purpose, corticosteroids are often applied topically. In a randomized, double-blind, placebo-controlled study, the efficacy of the topical application of 0.025% fluocinonide was evaluated. Forty consecutive patients with oral lichen planus diagnosed on the basis of histopathologic and immunofluorescence findings participated in this study. All patients were followed for 3 to 17 months. No adverse effects were noted during follow-up period. In the group of 20 patients that received the drug, 4 patients (20%) showed a complete remission, and 12 patients (60%) had a good or partial response to topical treatment. In the placebo-group, these figures were 0 and 6 (30%), respectively. The majority of the placebo-group (70%) did not respond at all with regard to signs (Xt2 = 10.4; p = 0.0013) and symptoms (Xt2 = 6.97, p = 0.008). The results from this study suggest that topical application of fluocinonide in an adhesive base is a safe and effective drug to reduce signs and symptoms in oral lichen planus. Oral lichen planus (OLP) is a chronic inflammatory disease that can be painful especially in the atrophic and erosive forms. Several therapies have been tried, with varying results. There is one case report in which aloe vera (AV) was used successfully in the treatment of lichen planus.
                To compare the efficacy of AV and placebo in the topical management of OLP.
                A randomized, double-blind, placebo-controlled trial was designed. Fifty-four patients were randomized into two groups to receive AV gel or placebo for 8 weeks.
                Fifty-four consecutive patients (34 women and 20 men) participated in the study. We found erosive and ulcerative lesions in 83% and 17%, respectively. The most common site of OLP was the lower lip. Twenty-two of 27 patients treated with AV (81%) had a good response after 8 weeks of treatment, while one of 27 placebo-treated patients (4%) had a similar response (P<0.001). Furthermore, two patients treated with AV (7%) had a complete clinical remission. Burning pain completely disappeared in nine patients treated with AV (33%) and in one treated with placebo (4%) (P=0.005). Symptomatology improved by at least 50% (good response) in 17 patients treated with AV (63%) and in two treated with placebo (7%) (P<0.001). No serious side-effects were found in both groups.
                AV gel is statistically significantly more effective than placebo in inducing clinical and symptomatological improvement of OLP. Therefore, AV gel can be considered a safe alternative treatment for patients with OLP. Oral lichen planus (OLP) is considered to be an autoimmune disease of unknown aetiology that affects the mucosae, especially the oral cavity. Objective: We compared tacrolimus 0.1% ointment and clobetasol 0.05% ointment for the treatment of OLP.
                A total of 32 patients (20 females and 12 males; all white, Italian origin, mean age of 43.6+/-18.4 years; 16 patients per treatment group) were treated with tacrolimus or clobetasol ointment for 4 weeks in a randomized, double-blind, clinical trial. Pain severity, burning sensation, and mucosal lesion extension were assessed using a four-point scale.
                At the end of the treatment period, symptom scores were significantly lower in the tacrolimus group than in the clobetasol group.
                The results of this study suggest that tacrolimus 0.1% ointment is more effective than clobetasol propionate 0.05% ointment in the treatment of OLP. However, other studies are needed to confirm the effectiveness of this treatment before it can be recommended for use in clinical practice. Oral lichen planus (OLP) is a chronic inflammatory disease that can be painful, especially in the atrophic and erosive forms. Several drugs have been used with varying results, but most treatments are empirical, and do not have adequate control groups or correct study designs.
                To compare the effectiveness of clobetasol and ciclosporin in the topical management of OLP and to evaluate which is more cost-effective and which gives the longest remission from signs and symptoms.
                A randomized, comparative, double-blind study was designed. Forty consecutive patients were divided into two groups to receive clobetasol propionate or ciclosporin for 2 months. Both drugs were placed in 4% hydroxyethyl cellulose bioadhesive gel. Antimycotic prophylaxis was also given. After the end of therapy, patients underwent a 2-month follow-up.
                Eighteen of 19 clobetasol-treated patients (95%) improved after 2 months of therapy, while 13 of 20 ciclosporin-treated patients (65%) had a clinical response (P = 0.04). Symptomatology improved in 18 clobetasol-treated patients (95%) and in 17 ciclosporin-treated patients (85%) (not statistically significantly different). Two months after the end of therapy, 33% of clobetasol-treated patients and 77% of ciclosporin-treated patients were stable (P = 0.04). Clobetasol produced significantly more side-effects than ciclosporin (P = 0.04). The daily cost of ciclosporin treatment was 1.82 compared with 0.35 for clobetasol therapy.
                Clobetasol is more effective than ciclosporin in inducing clinical improvement, but the two drugs have comparable effects on symptoms. Conversely, clobetasol gives less stable results than ciclosporin when therapy ends and has shown a higher incidence of side-effects. The daily cost of ciclosporin is more than five times higher than clobetasol. Symptomatic oral lichen planus (OLP) has been palliated with a wide spectrum of topical and systemic therapies. Although the majority of management strategies include corticosteroids, few have been evaluated in randomized controlled trials.
                We investigated the acceptability and efficacy of topical fluticasone propionate spray (FP) and betamethasone sodium phosphate mouthrinse (BSP) upon the signs and symptoms of OLP, assessing patient quality of life changes as a consequence of these therapies.
                We implemented a randomized, crossover study in which each drug was administered for a period of 6 weeks with an intervening washout period of 2 weeks at an outpatient oral medicine unit in London, United Kingdom. We treated 48 patients with biopsy-proven symptomatic OLP, and 44 patients (92%) completed the study. The dosage was 50 microg two dose unit sprays and BSP 500 microg, each 4 times daily. Symptomatic improvement was evaluated by means of a visual analogue scale (VAS), the McGill pain score, the Oral Health Impact Profile (OHIP), and Oral Health Quality of Life (OHQoL) questionnaires. The total surface area of the lesions, including all white, erythematous, and ulcerative lesions was measured at each visit. The efficacy, ease of application, and adverse effects associated with each medication were recorded.
                Both FP and BSP mouthwash caused both a statistically significant reduction in painful symptoms as measured by the VAS and improvement in quality of life as measured by the OHIP and OHoQL indices. There was no significant difference between the two corticosteroids in their efficacy in reducing painful symptoms (measured by the VAS) or in their effect on patient quality of life. Both FP and BSP significantly reduced the surface area of oral lesions. However, FP was statistically significantly better than BSP in reducing lesion surface area. There was no statistically significant difference between the patient-assessed effects of the 2 therapies.
                FP and BSP are both effective in the short-term clinical management of symptomatic OLP. FP is more acceptable to patients than BSP because of the convenience of the spray form. Oral lichen planus (OLP) is a chronic inflammatory disease that can be painful, mainly in the atrophic and erosive forms. Numerous drugs have been used with dissimilar results, but most treatments are empirical and do not have adequate control groups or correct study designs. However, to date, the most commonly employed and useful agents for the treatment of LP are topical corticosteroids. A randomized, double-blind, placebo-controlled trial has been designed to compare the efficacy and safety of two different formulations of clobetasol, a very potent topical steroid, in the topical management of OLP and to evaluate which gives the longest remission from signs and symptoms. Thirty-five consecutive patients were divided into two groups: the first received clobetasol propionate 0.025% and the second was given clobetasol propionate 0.05%. Both drugs were placed in 4% hydroxyethyl cellulose bioadhesive gel. Anti-mycotic prophylaxis was also added. After the end of therapy, patients received a 2-month follow-up. In all, 14 of the 15 clobetasol 0.025% patients (93%) and 13 of the 15 clobetasol 0.05% patients (87%), had symptoms improvement after 2 months of therapy (P = 0.001 in both groups). Also, 13 of the 15 clobetasol 0.025% patients (87%) and 11 of the 15 clobetasol 0.05% patients (73%) had clinical improvement after 2 months of therapy (P < 0.05 in both groups). No statistical differences were found in comparing the two different formulations. A larger concentration of the active molecules cannot further improve the therapeutic findings or optimize the obtained results in a significant manner. Topical steroids are the first choice for the treatment of oral lichen planus (OLP). Antifungal drugs are often employed together with them, to prevent secondary oral candidosis, although it has been suggested anecdotally that they can also be beneficial for OLP itself.
                To compare the effect of clobetasol propionate with and without a topical antifungal drug (miconazole) on the symptoms and extension of OLP.
                A randomized, parallel, double-blind trial was conducted at the Unit of Oral Medicine and Pathology of the University of Milan. Thirty-five outpatients with histologically proven OLP were randomly assigned to receive either clobetasol propionate and miconazole, or clobetasol propionate and placebo for 6 weeks. Primary outcomes included symptoms and extension of lesions; adverse effects were also recorded.
                All the patients who concluded the study (30 of 35) showed clinical and subjective improvement within 3 weeks. The addition of miconazole did not affect in a significant way the signs and symptoms of OLP. No cases of clinical candidosis were seen in the patients taking miconazole, while one-third (five of 15) of the placebo group were affected.
                Although effective in preventing iatrogenic candidosis, the addition of miconazole to topical steroid treatment does not improve the efficacy of the therapy. We studied the efficacy of curcuminoids in the treatment of oral lichen planus (OLP), a chronic, mucocutaneous, immunological disease. Curcuminoids are components of turmeric (Curcuma longa) that have anti-inflammatory activity. Turmeric has been used in Ayurveda (Indian traditional medicine) for centuries. A randomized, double-blind, placebo-controlled trial was conducted. In all, 100 consecutive, eligible patients with OLP presenting to the oral medicine clinic at the University of California, San Francisco, were to be selected. Two interim analyses were to be conducted during the trial. The trial was conducted between February 2003 and September 2004. The first interim analysis was conducted in October 2004 using data from the first 33 subjects. Study subjects were randomized to receive either placebo or curcuminoids at 2000 mg/day for 7 weeks. In addition, all subjects received prednisone at 60 mg/day for the first 1 week. The primary outcome was a change in symptoms from baseline. Secondary outcomes were changes in clinical signs and occurrence of side effects. The first interim analysis did not show a significant difference between the placebo and curcuminoids groups. Conditional power calculations suggested a less than 2% chance that the curcuminoids group would have a significantly better outcome as compared with the placebo group if the trial were continued to completion. Therefore, the study was ended early for futility. Reaching a conclusion regarding the efficacy of curcuminoids based on the results of this study is not possible as it was ended early for futility. Curcuminoids at this dose were well tolerated and the results suggest that for future studies a larger sample size, a higher dose and/or longer duration of curcuminoids administration should be considered; however, for the next step, an RCT of a shorter duration, using a higher dose of curcuminoids, and without an initial course of prednisone, should be considered. Oral lichen planus is a relatively common disorder of the mouth that can be debilitating. It is frequently palliated with topical or systemic corticosteroids and retinoids. These treatments require prolonged use, however, and are not always effective.
                In a double-blind trial, 16 patients with symptomatic oral lichen planus were randomly assigned to receive either topical cyclosporine or its vehicle. The patients swished and expectorated 5 ml of medication (containing 100 mg of cyclosporine per milliliter) three times daily.
                After eight weeks, the eight recipients of cyclosporine had marked improvement in erythema (P = 0.003), erosion (P = 0.02), reticulation (presence of white lacelike lesions; P = 0.007), and pain (P = 0.002), whereas the eight recipients of vehicle had no change or minimal improvement. After a switch to cyclosporine for eight weeks, the vehicle-treated patients had improvement similar to that seen in the patients who initially received cyclosporine. There were no systemic side effects. In most cases blood cyclosporine levels were low or undertectable. Cyclosporine levels present in specimens of oral mucosa at the end of therapy four hours after the patients swished were similar to the levels previously reported in psoriatic lesions after treatment with systemic cyclosporine (14 mg per kilogram of body weight per day).
                As a topical preparation, cyclosporine may be useful in the treatment of oral lichen planus and possibly other cutaneous disorders. To evaluate the efficacy of 1% pimecrolimus cream in treating oral erosive lichen planus and to assess its tolerance.
                Double-blind randomized trial with placebo control.
                Outpatients of the Department of Dermatology, University Hospital of Nice, from December 21, 2004, to April 19, 2005.
                Fourteen consecutive patients with oral erosive lichen planus confirmed by histological examination and with a clinical score superior to 3. Of the 14 patients, 2 did not meet the inclusion criteria and 12 were enrolled in the trial.
                The intervention was 1% pimecrolimus cream or its vehicle, which was applied on ulcerated lesions twice a day for 4 weeks.
                The efficacy of the treatment was quantified using a 12-point clinical score. The blood level of pimecrolimus was analyzed on days 0 (baseline), 14, and 28.
                In the placebo group, the mean score was 4.67 on day 0 vs 3.33 on day 28 (P = .22). In the pimecrolimus group, the mean score was 6.83 on day 0 vs 3.33 on day 28 (P = .04). In the pimecrolimus group, blood concentrations of pimecrolimus were always above the threshold (mean value, 2.84 ng/mL; extreme values, 0-6.19 ng/mL). Pimecrolimus cream was well tolerated, and only transient burning sensations were reported by some subjects. Each of the patients in the pimecrolimus group whose condition improved subsequently relapsed when assessed 1 month after treatment.
                The 1% pimecrolimus cream seems to be an effective and well-tolerated treatment for oral erosive lichen planus. The finding of systemic levels of pimecrolimus after mucosal applications necessitates long-term study because it seems that long-term application is required to maintain clinical improvement. 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.
                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.
                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).
                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).
                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. Lichen planus is a common chronic inflammatory mucocutaneous disease, affecting 0.1% to 4% of the general population. There is no published randomized active control clinical trial on pimecrolimus for the treatment of oral lichen planus (OLP).
                The purpose of this study was to compare the efficacy and safety of pimecrolimus 1% cream with triamcinolone acetonide 0.1% paste in treating OLP.
                In this investigator-blinded parallel-group randomized clinical trial, 40 patients were randomly assigned in two equal groups to receive either pimecrolimus 1% cream or triamcinolone acetonide 0.1% paste 4 times daily for a total of 2 months and followed up for another 2 months. The patients were assessed for painful symptoms measured by visual analog scale, the Oral Health Impact Profile score, and objective clinical score. Nonparametric tests were used to assess the main outcomes. Intention-to-treat analysis was used.
                Eighteen patients in pimecrolimus group and 17 patients in triamcinolone group finished the 4-month trial course. Both pimecrolimus and triamcinolone groups showed significant improvement in all measured efficacy end points throughout the visits. There was no significant difference between changes from baseline median values of pimecrolimus and triamcinolone groups after treatment termination in terms of visual analog scale score (-9.8 +/- 11.3 vs -8.4 +/- 18.3, P = .70), Oral Health Impact Profile score (-1.5 +/- 2.6 vs -1.6 +/- 2.1, P = .38), and clinical score (-0.7 +/- 0.6 vs -0.8 +/- 0.7, P = .86), respectively. Two patients in pimecrolimus group experienced prominent but transient burning sensation whereas none of the patients in triamcinolone group had any prominent adverse event (P = .24).
                Blood levels in pimecrolimus group were not measured and carcinogenicity of pimecrolimus, especially in its long-term use for OLP, is yet to be determined.
                This study showed that patients with OLP may benefit from both topical pimecrolimus and triamcinolone acetonide therapy with minimal side effects. Further studies should be conducted to assess the maintenance effects and long-term safety of both drugs (Cochrane skin group identifier: CSG TrialNo. 22).