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BMJ Clinical Evidence May 2015Seborrhoeic dermatitis affects a variable proportion of the general population, ranging from 3% to 10%. Malassezia yeast species (previously referred to as Pityrosporum)... (Review)
Review
INTRODUCTION
Seborrhoeic dermatitis affects a variable proportion of the general population, ranging from 3% to 10%. Malassezia yeast species (previously referred to as Pityrosporum) are thought to be the responsible organisms, and cause inflammation by still poorly defined mechanisms. Seborrhoeic dermatitis tends to relapse after treatment.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of topical treatments for seborrhoeic dermatitis of the scalp in adults? We searched: Medline, Embase, The Cochrane Library, and other important databases up to November 2013 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 14 studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: bifonazole, ciclopirox, ketoconazole, pyrithione zinc, selenium sulfide, tar shampoo, terbinafine, and topical corticosteroids (betamethasone valerate, clobetasol propionate, clobetasone butyrate, hydrocortisone, mometasone furoate).
Topics: Administration, Topical; Dermatitis, Seborrheic; Humans
PubMed: 26016669
DOI: No ID Found -
The Cochrane Database of Systematic... Feb 2020Oral lichen planus (OLP) is a relatively common chronic T cell-mediated disease, which can cause significant pain, particularly in its erosive or ulcerative forms. As... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Oral lichen planus (OLP) is a relatively common chronic T cell-mediated disease, which can cause significant pain, particularly in its erosive or ulcerative forms. As pain is the indication for treatment of OLP, pain resolution is the primary outcome for this review. This review is an update of a version last published in 2011, but focuses on the evidence for corticosteroid treatment only. A second review considering non-corticosteroid treatments is in progress.
OBJECTIVES
To assess the effects and safety of corticosteroids, in any formulation, for treating people with symptoms of oral lichen planus.
SEARCH METHODS
Cochrane Oral Health's Information Specialist searched the following databases to 25 February 2019: Cochrane Oral Health's Trials Register, CENTRAL (2019, Issue 1), MEDLINE Ovid, and Embase Ovid. ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. There were no restrictions on language or date of publication.
SELECTION CRITERIA
We considered randomised controlled clinical trials (RCTs) of any local or systemic corticosteroid treatment compared with a placebo, a calcineurin inhibitor, another corticosteroid, any other local or systemic (or both) drug, or the same corticosteroid plus an adjunctive treatment.
DATA COLLECTION AND ANALYSIS
Three review authors independently scanned the titles and abstracts of all reports identified, and assessed risk of bias using the Cochrane tool and extracted data from included studies. For dichotomous outcomes, we expressed the estimates of effects of an intervention as risk ratios (RR), with 95% confidence intervals (CI). For continuous outcomes, we used mean differences (MD) and 95% CI. The statistical unit of analysis was the participant. We conducted meta-analyses only with studies of similar comparisons reporting the same outcome measures. We assessed the overall certainty of the evidence using GRADE.
MAIN RESULTS
We included 35 studies (1474 participants) in this review. We assessed seven studies at low risk of bias overall, 11 at unclear and the remaining 17 studies at high risk of bias. We present results for our main outcomes, pain and clinical resolution measured at the end of the treatment course (between one week and six months), and adverse effects. The limited evidence available for comparisons between different corticosteroids, and corticosteroids versus alternative or adjunctive treatments is presented in the full review. Corticosteroids versus placebo Three studies evaluated the effectiveness and safety of topical corticosteroids in an adhesive base compared to placebo. We were able to combine two studies in meta-analyses, one evaluating clobetasol propionate and the other flucinonide. We found low-certainty evidence that pain may be more likely to be resolved when using a topical corticosteroid rather than a placebo (RR 1.91, 95% CI 1.08 to 3.36; 2 studies, 72 participants; I² = 0%). The results for clinical effect of treatment and adverse effects were inconclusive (clinical resolution: RR 6.00, 95% CI 0.76 to 47.58; 2 studies, 72 participants; I² = 0%; very low-certainty evidence; adverse effects RR 1.48, 95% 0.48 to 4.56; 3 studies, 88 participants, I² = 0%, very low-certainty evidence). Corticosteroids versus calcineurin inhibitors Three studies compared topical clobetasol propionate versus topical tacrolimus. We found very low-certainty evidence regarding any difference between tacrolimus and clobetasol for the outcomes pain resolution (RR 0.45, 95% CI 0.24 to 0.88; 2 studies, 100 participants; I² = 80%), clinical resolution (RR 0.61, 95% CI 0.38 to 0.99; 2 studies, 52 participants; I² = 95%) and adverse effects (RR 0.05, 95% CI 0.00 to 0.83; 2 studies, 100 participants; very low-certainty evidence) . One study (39 participants) compared topical clobetasol and ciclosporin, and provided only very low-certainty evidence regarding the rate of clinical resolution with clobetasol (RR 3.16, 95% CI 1.00 to 9.93), pain resolution (RR 2.11, 95% CI 0.76 to 5.86) and adverse effects (RR 6.32, 95% CI 0.84 to 47.69). Two studies (60 participants) that compared triamcinolone and tacrolimus found uncertain evidence regarding the rate of clinical resolution (RR 0.86, 95% CI 0.55 to 1.35; very low-certainty evidence) and that there may be a lower rate of adverse effects in the triamcinolone group (RR 0.47, 95% CI 0.22 to 0.99; low-certainty evidence). These studies did not report on pain resolution.
AUTHORS' CONCLUSIONS
Corticosteroids have been first line for the treatment of OLP. This review found that these drugs, delivered topically as adhesive gels or similar preparations, may be more effective than placebo for reducing the pain of symptomatic OLP; however, with the small number of studies and participants, our confidence in the reliability of this finding is low. The results for clinical response were inconclusive, and we are uncertain about adverse effects. Very low-certainty evidence suggests that calcineurin inhibitors, specifically tacrolimus, may be more effective at resolving pain than corticosteroids, although there is some uncertainty about adverse effects and clinical response to tacrolimus showed conflicting results.
Topics: Adrenal Cortex Hormones; Calcineurin Inhibitors; Clobetasol; Cyclosporine; Humans; Lichen Planus, Oral; Oral Health; Pain Management; Randomized Controlled Trials as Topic; Tacrolimus
PubMed: 32108333
DOI: 10.1002/14651858.CD001168.pub3 -
BMC Oral Health May 2022To compare the reported efficacy and costs of available interventions used for the management of oral lichen planus (OLP).
OBJECTIVE
To compare the reported efficacy and costs of available interventions used for the management of oral lichen planus (OLP).
MATERIALS AND METHODS
A systematic literature search was performed from database inception until March 2021 in MEDLINE via PubMed and the Cochrane library following PRISMA guidelines. Only randomized controlled trials (RCT) comparing an active intervention with placebo or different active interventions for OLP management were considered.
RESULTS
Seventy (70) RCTs were included. The majority of evidence suggested efficacy of topical steroids (dexamethasone, clobetasol, fluocinonide, triamcinolone), topical calcineurin inhibitors (tacrolimus, pimecrolimus, cyclosporine), topical retinoids, intra-lesional triamcinolone, aloe-vera gel, photodynamic therapy, and low-level laser therapies for OLP management. Based on the estimated cost per month and evidence for efficacy and side-effects, topical steroids (fluocinonide > dexamethasone > clobetasol > triamcinolone) appear to be more cost-effective than topical calcineurin inhibitors (tacrolimus > pimecrolimus > cyclosporine) followed by intra-lesional triamcinolone.
CONCLUSION
Of common treatment regimens for OLP, topical steroids appear to be the most economical and efficacious option followed by topical calcineurin inhibitors. Large-scale multi-modality, prospective trials in which head-to-head comparisons interventions are compared are required to definitely assess the cost-effectiveness of OLP treatments.
Topics: Administration, Topical; Calcineurin Inhibitors; Clobetasol; Cyclosporins; Dexamethasone; Fluocinonide; Health Care Costs; Humans; Lichen Planus, Oral; Steroids; Tacrolimus; Treatment Outcome; Triamcinolone
PubMed: 35524296
DOI: 10.1186/s12903-022-02168-4 -
The Lancet. Oncology Aug 2019Regorafenib confers an overall survival benefit in patients with refractory metastatic colorectal cancer; however, the adverse event profile of regorafenib has limited... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Regorafenib confers an overall survival benefit in patients with refractory metastatic colorectal cancer; however, the adverse event profile of regorafenib has limited its use. Despite no supportive evidence, various dosing schedules are used clinically to alleviate toxicities. This study evaluated the safety and activity of two regorafenib dosing schedules.
METHODS
In this randomised, multicentre, open-label, phase 2 study done in 39 outpatient cancer centres in the USA, adults aged 18 years or older with histologically or cytologically confirmed advanced or metastatic adenocarcinoma of the colon or rectum that was refractory to previous standard therapy, including EGFR inhibitors if KRAS wild-type, were enrolled. Eligible patients had an Eastern Cooperative Oncology Group performance status of 0-1 and had no previous treatment with regorafenib. Patients were randomly assigned (1:1:1:1) into four groups with two distinct regorafenib dosing strategies and two clobetasol usage plans, stratified by hospital. Regorafenib dosing strategies were a dose-escalation strategy (starting dose 80 mg/day orally with weekly escalation, per 40 mg increment, to 160 mg/day regorafenib) if no significant drug-related adverse events occurred and a standard-dose strategy (160 mg/day orally) for 21 days of a 28-day cycle. Clobetasol usage plans (0·05% clobetasol cream twice daily applied to palms and soles) were either pre-emptive or reactive. After randomisation to the four preplanned groups, using the Pocock and Simon dynamic allocation procedures stratified by the treating hospitals, we formally tested the interaction between the two interventions, dosing strategy and clobetasol usage. Given the absence of a significant interaction (p=0·74), we decided to pool the data for the pre-emptive and reactive treatment with clobetasol and compared the two dosing strategies (dose escalation vs standard dose). The primary endpoint was the proportion of evaluable patients (defined as those who were eligible, consented, and received any protocol treatment) initiating cycle 3 and was analysed per protocol. Superiority for dose escalation was declared if the one-sided p value with Fisher's exact test was less than 0·2. This trial is registered with ClinicalTrials.gov, number NCT02368886. This study is fully accrued but remains active.
FINDINGS
Between June 2, 2015, and June 22, 2017, 123 patients were randomly assigned to treatment, of whom 116 (94%) were evaluable. The per-protocol population consisted of 54 patients in the dose-escalation group and 62 in the standard-dose group. At data cutoff on July 24, 2018, median follow-up was 1·18 years (IQR 0·98-1·57). The primary endpoint was met: 23 (43%, 95% CI 29-56) of 54 patients in the dose-escalation group initiated cycle 3 versus 16 (26%, 15-37) of 62 patients in the standard-dose group (one-sided p=0·043). The most common grade 3-4 adverse events were fatigue (seven [13%] patients in the dose-escalation group vs 11 [18%] in the standard-dose group), hand-foot skin reaction (eight [15%] patients vs ten [16%] patients), abdominal pain (nine [17%] patients vs four [6%] patients), and hypertension (four [7%] patients vs nine [15%] patients). 14 patients had at least one drug-related serious adverse event: six patients in the dose-escalation group and eight patients in the standard-dose group. There was one probable treatment-related death in the standard-dose group (myocardial infarction).
INTERPRETATION
The dose-escalation dosing strategy represents an alternative approach for optimising regorafenib dosing with comparable activity and lower incidence of adverse events and could be implemented in clinical practice on the basis of these data.
FUNDING
Bayer HealthCare Pharmaceuticals.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Agents; Colorectal Neoplasms; Dose-Response Relationship, Drug; Female; Humans; Male; Middle Aged; Phenylurea Compounds; Pyridines
PubMed: 31262657
DOI: 10.1016/S1470-2045(19)30272-4 -
Dermatology Online Journal Dec 2019As wearable devices play an increasing role in the management of health and disease, adverse skin reactions to wearables have become more common. However, the management...
As wearable devices play an increasing role in the management of health and disease, adverse skin reactions to wearables have become more common. However, the management of allergic contact dermatitis is challenging and new treatment options more compatible with wearable devices are needed. In a 40-year-old woman with contact dermatitis to a continuous glucose monitoring device, topical clobetasol propionate 0.05% spray proved to be an effective treatment that was compatible with the application of adhesive wearables. This case demonstrates that spray formulations of topical steroids are a good option for the treatment of dermatitis under wearable devices such as continuous glucose monitors or ostomy appliance.
Topics: Administration, Topical; Adult; Blood Glucose Self-Monitoring; Clobetasol; Dermatitis, Allergic Contact; Female; Humans; Receptors, Glucocorticoid; Wearable Electronic Devices
PubMed: 32045171
DOI: No ID Found -
Frontiers in Immunology 2019Dermatitis herpetiformis (DH) is an inflammatory disease of the skin, considered the specific cutaneous manifestation of celiac disease (CD). Both DH and CD occur in... (Review)
Review
Dermatitis herpetiformis (DH) is an inflammatory disease of the skin, considered the specific cutaneous manifestation of celiac disease (CD). Both DH and CD occur in gluten-sensitive individuals, share the same Human Leukocyte Antigen (HLA) haplotypes (DQ2 and DQ8), and improve following the administration of a gluten-free diet. Moreover, almost all DH patients show typical CD alterations at the small bowel biopsy, ranging from villous atrophy to augmented presence of intraepithelial lymphocytes, as well as the generation of circulating autoantibodies against tissue transglutaminase (tTG). Clinically, DH presents with polymorphic lesions, including papules, vesicles, and small blisters, symmetrically distributed in typical anatomical sites including the extensor aspects of the limbs, the elbows, the sacral regions, and the buttocks. Intense pruritus is almost the rule. However, many atypical presentations of DH have also been reported. Moreover, recent evidence suggested that DH is changing. Firstly, some studies reported a reduced incidence of DH, probably due to early recognition of CD, so that there is not enough time for DH to develop. Moreover, data from Japanese literature highlighted the absence of intestinal involvement as well as of the typical serological markers of CD (i.e., anti-tTG antibodies) in Japanese patients with DH. Similar cases may also occur in Caucasian patients, complicating DH diagnosis. The latter relies on the combination of clinical, histopathologic, and immunopathologic findings. Detecting granular IgA deposits at the dermal-epidermal junction by direct immunofluorescence (DIF) from perilesional skin represents the most specific diagnostic tool. Further, assessing serum titers of autoantibodies against epidermal transglutaminase (eTG), the supposed autoantigen of DH, may also serve as a clue for the diagnosis. However, a study from our group has recently demonstrated that granular IgA deposits may also occur in celiac patients with non-DH inflammatory skin diseases, raising questions about the effective role of eTG IgA autoantibodies in DH and suggesting the need of revising diagnostic criteria, conceivably emphasizing clinical aspects of the disease along with DIF. DH usually responds to the gluten-free diet. Topical clobetasol ointment or dapsone may be also applied to favor rapid disease control. Our review will focus on novel pathogenic insights, controversies, and management aspects of DH.
Topics: Administration, Topical; Autoantibodies; Celiac Disease; Clobetasol; Dapsone; Dermatitis Herpetiformis; Diet, Gluten-Free; GTP-Binding Proteins; HLA-DQ Antigens; Humans; Immunoglobulin A; Protein Glutamine gamma Glutamyltransferase 2; Transglutaminases
PubMed: 31244841
DOI: 10.3389/fimmu.2019.01290 -
Swiss Dental Journal 2017Oral lichen planus is a relatively common T-cell mediated inflammatory disease with potential malignant transformation. It may present itself with pain and oral lesions...
Oral lichen planus is a relatively common T-cell mediated inflammatory disease with potential malignant transformation. It may present itself with pain and oral lesions such as ulcers and Wickhams striae. Treatment includes topical corticosteroids, preferably Clobetasol, immunosuppressive drugs and retinoids. Hyaluronic acid and aloe vera have been proven to be successful. If topical treatment fails, systemic therapy with corticosteroids may be needed. Because of the potential malignant transformation periodic follow-up is mandatory.
Topics: Administration, Topical; Adrenal Cortex Hormones; Adult; Aloe; Cell Transformation, Neoplastic; Clobetasol; Cross-Sectional Studies; Humans; Hyaluronic Acid; Immunosuppressive Agents; Lichen Planus, Oral; Middle Aged; Retinoids
PubMed: 28639683
DOI: No ID Found -
Open Access Macedonian Journal of... Jul 2017A 16 years old female patient, affected by atopic dermatitis and rhinoconjunctivitis allergica since childhood, requested a dermatologic consultation for lesions which...
A 16 years old female patient, affected by atopic dermatitis and rhinoconjunctivitis allergica since childhood, requested a dermatologic consultation for lesions which had appeared after 3 months of local treatment with clobethasole propionate. The histological analysis confirmed the diagnosis of dyshidrotic eczema and the microbiological smears demonstrated a significant infection with . The risk of developing corticosteroids' side-effects depends on the potency of the product, extended period of use and the volume of product applied. Clobetasol propionate is a group I- highly potent corticosteroid, which should be used for a maximum period of 2 weeks. Several authors have found that this agent has cumulative depot effect, persisting in the epidermis for 4 days after only one application. Taking together these observations, sustained by the clinical case presented above, we can conclude that the infectious risks associated with topical corticosteroid treatment must not be neglected, particularly since treated patients are fragile, and frequently have multiple well-known risk factors.
PubMed: 28785355
DOI: 10.3889/oamjms.2017.081 -
Experimental and Therapeutic Medicine Aug 2019Clobetasol propionate (Clo) is a potent topical glucocorticoid and a potential remyelinating agent that has been approved by the U.S. Food and Drug Administration....
Clobetasol propionate (Clo) is a potent topical glucocorticoid and a potential remyelinating agent that has been approved by the U.S. Food and Drug Administration. However, the effect of Clo on neural stem cells (NSCs) remains largely unknown. The aim of the present study was to investigate the effect of Clo on the differentiation of NSCs . NSCs were isolated from mouse embryonic brain tissues and expanded . The effect of Clo on NSC viability was examined using an MTT assay. Differentiating NSCs were treated with 5 or 10 µM Clo, or with DMSO control, and the degree of differentiation was examined following culture in stem cell differentiation induction medium for 7 days. The effect of Clo on NSC differentiation was assessed using immunocytochemistry and western blot analyses. The results revealed that Clo significantly increased NSC viability compared with the DMSO control group. Treatment with Clo also significantly increased the number of NSCs that differentiated into growth associated protein 43 positive neurons and corresponding axon lengths were also significantly increased. In addition, treatment with Clo significantly increased the number of myelin basic protein positive oligodendrocytes and decreased the number of glial fibrillary acidic protein positive astrocytes. Furthermore, inhibition of the sonic hedgehog and AMP-activated protein kinase signaling pathways inhibited Clo-induced NSC differentiation, and treatment with Clo upregulated the expression of several neurotrophic factors. In conclusion, the results of the current study suggest that Clo may have a potential therapeutic benefit in neurological disorders affecting oligodendrocytes and neurons.
PubMed: 31363370
DOI: 10.3892/etm.2019.7692