Tacrolimus 0.3% in Clobetasol 0.05% ointment

OBJECTIVE: This systematic review synthesizes existing empirical evidence on the efficacy and safety of pharmacological treatment options for desquamative gingivitis (DG), in order to establish evidence-based clinical recommendations on DG clinical management. METHODS: A comprehensive literature search was conducted across seven databases to retrieve literature records published from 1990 to 2023, followed by manual searches of reference lists of the included articles. Studies assessing pharmacological interventions for DG with relevant clinical outcomes were included. Study quality was assessed using the Mixed Methods Appraisal Tool (MMAT). Relevant data, including those on clinical improvement and adverse events, were extracted and synthesised to determine the efficacy and safety of the pharmacological agents used in the included articles. RESULTS: Out of the yielded 624 records and the manual search, 15 studies met the inclusion criteria, comprising randomized controlled trials (RCTs), non-randomized trials and cohort studies. MMAT scores ranged from 5 to 7, with a mean score of 5.57. Clobetasol (53.33%) and tacrolimus (26.67%) were the most frequently studied agents, both demonstrating significant reductions in pain and lesion severity. Emerging therapies, such as platelet-rich plasma and bio-adhesive gels containing propolis and nano-vitamin formulations, showed promising results, particularly as adjunctive treatments. Quality of life (QoL) assessments was limited, with only one study employing a validated tool (OHIP-14). Recurrence rates were inconsistently reported with no reported relapses in clobetasol-treated groups during short-term follow-up. Safety profiles differed across pharmacological agents with topical treatments exhibiting mild and transient adverse effects. Systemic agents exhibited a higher risk profile, including candidiasis and haemolysis. CONCLUSIONS: Clobetasol and tacrolimus remain first-line therapies for DG, supported by their efficacy and manageable safety profiles. Platelet-rich plasma and nano-vitamin-based therapies offer potential alternatives but require further validation. Given the variability in treatment protocols, standardized guidelines and long-term studies are needed to optimize the clinical management. CLINICAL TRIAL NUMBER: Not applicable.

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Background: Establishing effective treatment for cutaneous lupus erythematosus (CLE) is of major importance given lack of approved medications for this autoimmune condition. Topical calcineurin inhibitors have been used to treat all types of CLE, yet there is currently no robust study that evaluated the efficacy of calcineurin inhibitors in this patient population. Our aim is to study the efficacy of topical calcineurin inhibitors for treating patients with CLE and assess the side effects associated with the use of this class of medications. Materials and methods: A systematic review was conducted following the AMSTAR guidelines. A systematic search for articles published between 2003 and 2024 in PubMed, MEDLINE, the Cochrane library (Cochrane Databases of Systematic Reviews), and the Cochrane Register of Controlled Trials for relevant studies that assessed the efficacy of calcineurin inhibitors in patients with CLE. Results: Twenty-five studies met the criteria, and we reviewed and collectively included. Based on the Quality assessment, some concerns are raised in the quality assessment of RCTs studies. However, Observational studies have high methodological quality. Conclusion: In conclusion, our systematic review analyzed 25 studies to evaluate the efficacy and safety of topical calcineurin inhibitors in treating CLE. Our systematic review findings support the effectiveness of these inhibitors, namely pimecrolimus cream and tacrolimus ointment in improving clinical manifestations and disease activity in various forms of CLE, such as discoid lupus and subacute CLE. However, the result from RCTs metanalysis showed no significant difference between calcineurin inhibitors and other treatments. While calcineurin inhibitors are generally safe, the most common side effect was skin burning sensation at application site in the first few days of treatment. Further research is needed to prove the effectiveness of these drugs, explore the comparative effectiveness between different calcineurin inhibitors and comparing their types and their concentration.

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INTRODUCTION: Lichen sclerosus (LS) is a chronic inflammatory dermatosis affecting both genital and extragenital sites, with a prevalence of approximately 3% among females in the United Kingdom, particularly in the post-menopausal population. Although its etiology remains incompletely understood, LS can significantly impair quality of life through pain, pruritus, and scarring. Current guidelines recommend potent topical corticosteroids, most commonly clobetasol, as first-line therapy; however, long-term use is limited by adverse effects such as skin atrophy. OBJECTIVES: This systematic review evaluates the efficacy and safety of topical tacrolimus in the management of lichen sclerosus. METHODS: A comprehensive literature search was conducted in accordance with PRISMA guidelines. Fourteen randomized controlled trials comprising 335 patients with lichen sclerosus were included. RESULTS: Of the included patients, 2% (N=6) presented with extragenital disease and 98% (N=331) with anogenital involvement. Most patients (81%, N=272) were treated with topical tacrolimus 0.1% twice daily, while 19% (N=63) received clobetasol as a comparator. Clinical improvement, ranging from partial symptom relief to complete remission, was observed in 90% (N=244) of tacrolimustreated patients. Severe adverse events requiring discontinuation were rare (1%, N=3). Compared with corticosteroids, tacrolimus was associated with superior patient-reported outcomes, clinician-reported improvement, and histological response. CONCLUSION: Topical tacrolimus appears to be a safe and effective therapeutic option for lichen sclerosus, demonstrating favorable clinical and histological outcomes with minimal adverse effects. Further long-term prospective trials are needed to confirm its comparative efficacy, safety, and role in future treatment guidelines.

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Background: Vascularized composite allotransplantation (VCA) offers unique reconstructive solutions for severe tissue loss, restoring form and function. Acute and chronic rejection remains a significant barrier, with acute episodes occurring in most recipients and chronic rejection persisting as the leading cause of graft failure. Unlike solid organ transplantation, VCA involves highly immunogenic tissues, like skin and mucosa, making rejection more frequent and challenging to manage. Methods: A systematic review was conducted following PRISMA 2020, searching PubMed/MEDLINE, EMBASE, and Web of Science for original human VCA studies reporting immunosuppressive protocols and outcomes in acute or chronic rejection. Quality was assessed using the Newcastle-Ottawa Scale and Level of Evidence; extracted data included demographics, regimens, rejection episodes, treatments, and graft survival. Results: Fourty-six studies (136 recipients) met inclusion criteria: upper extremity (n=69; 51%), face (n=33; 24%), abdominal wall (n=33; 24%), scalp and penile (each n=1; 0.7%). Acute rejection occurred in 81/136 (60%) within year 1, most often at POW 1-2 (n=52), 5-12 (n=42), and 13-52 (n=30). Severity was Banff grade I (n=49; 36%), II (n=73; 54%), III (n=50; 37%), and severe IV (n=1; 0.7%). Common symptoms included skin lesions (n=43; 32%), edema (n=32; 24%), erythema (n=29; 21%), and rash (n=15; 11%), with some experiencing numbness (n=4; 2.9%), tingling (n=5; 3.7%), or burning sensations (n=5; 3.7%). Corticosteroids were the mainstay (n=98; 72%)-methylprednisolone (n=31; 23%), clobetasol (n=15; 11%), and prednisone (n=11; 8.1%); tacrolimus was used in 49 (36%), including topical in 29 (21%). Other immunosuppressants included antithymocyte globulin (n=19; 14%), alemtuzumab (n=11; 8.1%), mycophenolate mofetil (n=11; 8.1%), and rituximab (n=6; 4.4%); basiliximab (n=4; 2.9%), sirolimus (n=2; 1.5%), and plasmapheresis (n=4; 2.9%) were used selectively. Monotherapy was used in 42 episodes, and dual therapy in 51, most commonly methylprednisolone plus topical tacrolimus (n=26). Conclusion: This review underscores the ongoing challenge of rejection in VCA and the need for improved treatment strategies, with corticosteroids, calcineurin inhibitors, and mycophenolate mofetil remaining standard while emerging biologicals offer promise. Acute rejection is often manageable yet threatens graft survival, whereas chronic rejection is less reported, likely under-recognized and harder to treat, underscoring need for novel immunomodulators, standardized protocols, and prevention to improve outcomes.

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BACKGROUND: Oral lichen planus (OLP) is believed to result from an abnormal T-cell mediated immune response. The most useful agent in the treatment is corticosteroids. The present study will be aimed at evaluation of therapeutic efficiency of two corticosteroids triamcinolone acetonate (0.1%) and clobetasol propionate with tacrolimus orabase (0.03%), an immunomodulator in the management of OLP. AIM: To compare the effectiveness of topical triamcinolone acetonate (0.1%), clobetasol propionate (0.05%), and tacrolimus orabase (0.03%) in the management of OLP and also to compare which has less recurrence. STUDY DESIGN: The study comprises 30 patients, all were diagnosed with OLP clinically and histopathologically. They are randomly divided into three groups: Group A - triamcinolone acetonate (0.1%), Group B - clobetasol propionate (0.05%), and Group C - tacrolimus (0.03%). A formal informed consent was obtained from all of them who participated in the study. RESULTS AND CONCLUSION: Subjects in the Group A (triamcinolone 0.1%) and Group B (clobetasol 0.05%) show a significant reduction in lesion size than that of Group C (tacrolimus 0.03%). Group B (clobetasol 0.05%) shows a better significant reduction in lesion size than that of Group A (triamcinolone 0.1%). The overall treatment response was significant better in the Group B (clobetasol 0.05%). No recurrence was observed in any of the three groups at the end of 3 months. It is concluded that clobetasol propionate 0.05% ointment has higher efficacy when compared to triamcinolone acetonide 0.1% ointment and tacrolimus ointment 0.03% in the management of OLP. It was also inferred that triamcinolone 0.1% has better effects than tacrolimus 0.03%.

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