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Aqueous olanexidine versus aqueous povidone-iodine for surgical skin antisepsis on the incidence of surgical site infections after clean-contaminated surgery: a multicentre, prospective, blinded-endpoint, randomised controlled trial.
Obara, H, Takeuchi, M, Kawakubo, H, Shinoda, M, Okabayashi, K, Hayashi, K, Sekimoto, Y, Maeda, Y, Kondo, T, Sato, Y, et al
The Lancet. Infectious diseases. 2020;(11):1281-1289
Abstract
BACKGROUND Surgical site infection (SSI) is the most common problem after surgery. Although several guidelines have indicated the efficacy of antiseptics, such as chlorhexidine-alcohol and povidone-iodine, in reducing SSI rate, the optimal recommendation is still not established. Olanexidine might have higher bactericidal activity than other antiseptic agents. However, no randomised study has evaluated the efficacy and safety of olanexidine over conventional antiseptics. We compared the effect of aqueous olanexidine and aqueous povidone-iodine on the incidence of SSI following clean-contaminated surgery. METHODS This was a multicentre, prospective, randomised, blinded-endpoint superiority trial for surgical skin antisepsis in clean-contaminated gastrointestinal and hepatobiliary pancreatic surgeries in four Japanese hospitals. Patients aged 20 years or older who underwent elective clean-contaminated wound surgery were randomly assigned in a 1:1 replacement ratio using a computer-generated block randomisation. Patients were randomly assigned to surgical skin antisepsis with an aqueous formulation of 1·5% olanexidine or surgical skin antisepsis with an aqueous formulation of 10% povidone-iodine before surgery. We used olanexidine in a ready-to-use applicator, and povidone-iodine was administered by a brush or by compression using pliers. Both antiseptics were applied from the papilla with a cranial limit and to the upper thigh with a caudal limit. The antiseptics were allowed to dry for 3 min, and then surgery started. Participants, some investigators, and data analysts were masked to treatment allocation. Participant enrolment was done by non-masked investigators. The primary outcome was 30-day SSI assessed in the intention-to-treat population. The surgical wound site of each participant was observed daily. After discharge, participants underwent at least one outpatient visit within 30 days after surgery. This trial is registered with University hospital Medical Information Network, 000031560. FINDINGS Between June 10, 2018, and April 18, 2019, 883 patients were assessed for eligibility. 587 patients were eligible and 294 received olanexidine and 293 received aqueous povidone-iodine before surgery. 30-day SSI occurred in 19 (7%) patients in the olanexidine group and 39 patients (13%) patients in the povidone-iodine group (adjusted risk difference -0·069; 90% CI -0·109 to -0·029; adjusted risk ratio [RR] 0·48, 90% CI 0·30 to 0·74; p=0·002). Five patients (2%) in the olanexidine group and five (2%) in the povidone-iodine group developed adverse skin reactions (adjusted RR 0·99, 95% CI 0·29 to 3·40; p=1·00). INTERPRETATION Olanexidine significantly reduced the occurrence of overall SSI and superficial incisional SSI compared with aqueous povidone-iodine in clean-contaminated surgery. Our results indicate that olanexidine might have a role to prevent SSI in patients who undergo clean-contaminated surgeries. FUNDING Keio University and Ohyama Health Foundation.
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Calcipotriol/betamethasone ointment compared to narrow-band UVB in plaque psoriasis: first clinical and ultrasonographic study.
Polańska, A, Gaura, T, Bowszyc-Dmochowska, M, Osmola-Mańkowska, A, Olek-Hrab, K, Adamski, Z, Żaba, R, Dańczak-Pazdrowska, A
International journal of dermatology. 2019;(1):108-113
Abstract
INTRODUCTION A wide range of treatments are available for psoriasis, including pharmaceuticals and phototherapy. Calcipotriol/betamethasone dipropionate and narrow-band ultraviolet phototherapy (NB-UVB) are both effective monotherapies for psoriasis; however, these two therapies have never been directly compared in a prospective clinical study. In this study, we compared the efficacy of combined calcipotriol/betamethasone dipropionate to NB-UVB in psoriatic patients with Psoriasis Area Severity Index (PASI) 9-10 treated in a routine clinical practice. PATIENTS AND METHODS This prospective, observational study included 58 consecutive patients (age range, 19-65 years) diagnosed with recurrent chronic small plaque psoriasis. Patients were offered either topical therapy with a two-compound ointment containing calcipotriol (50 μm/g) and betamethasone dipropionate (0.5 mg/g) or NB-UVB (311 nm). Disease severity was assessed at baseline and posttreatment according to PASI and target lesion score (TLS) and by high-frequency (20 MHz) ultrasonography (HF-USG). RESULTS No statistically significant difference between the groups was observed in baseline or posttreatment PASI scores. Both treatments resulted in substantial reductions in PASI 85% and 82%, respectively, for the calcipotriol/betamethasone group and the NB-UVB group. Both treatments significantly decreased the subepidermal low echogenic band (SLEB) thickness, with no significant differences between the two groups in terms of the percentage reduction in SLEB. CONCLUSIONS This study demonstrates, for the first time, that NB-UVB phototherapy and fixed combination calcipotriol/betamethasone ointment are equally effective in treating plaque psoriasis in patients with PASI 9-10 in routine clinical practice. In addition, measurement of SLEB thickness with HF-USG may be a useful objective parameter to assess skin lesions.
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Topical calcipotriol vs narrowband ultraviolet B in treatment of alopecia areata: a randomized-controlled trial.
El Taieb, MA, Hegazy, EM, Ibrahim, HM, Osman, AB, Abualhamd, M
Archives of dermatological research. 2019;(8):629-636
Abstract
Alopecia areata is a chronic relapsing autoimmune inflammatory hair disorder with no novel therapy. The objectives of this study are to compare the efficacy of topical calcipotriol vs narrow band ultraviolet B phototherapy (NB-UVB) in the treatment of alopecia areata and its correlation with serum vitamin D3 levels. A randomized-controlled trial has been conducted on 60 patients with scalp alopecia areata randomized into four groups; topical calcipotriol, NB-UVB, both and placebo. All patients were evaluated by assessment of severity of alopecia areata by severity of alopecia tool (SALT) score at baseline and 3 months after treatment and vitamin D3 levels at baseline and after 3 months. SALT score and vitamin D3 levels were significantly improved in all groups except placebo after treatment with (P = 0.026, P = 0.005, P = 0.004, P = 0.140) and (P = 0.028, P = 0.011, P = 0.003, P = 0.725), respectively. Combined therapy showed non-significant improvement in SALT score (P = 0.530, P = 0.643), respectively, and significant improvement in serum vitamin D3 levels than each line alone with (P = 0.021, P = 0.044), respectively. Both topical calcipotriol and NB-UVB are effective therapies in the treatment of AA and associated with improvement of SALT score and vitamin D3 levels.
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Evaluation of the efficacy of transdermal drug delivery of calcipotriol plus betamethasone versus tacrolimus in the treatment of vitiligo.
Ibrahim, ZA, Hassan, GF, Elgendy, HY, Al-Shenawy, HA
Journal of cosmetic dermatology. 2019;(2):581-588
Abstract
BACKGROUND Vitiligo is a common pigmentary disorder affecting about 1% of the general population. There are numerous medical and surgical treatments. Microneedling is an evolving treatment technique for an expanding number of dermatologic conditions. It is used also to augment transdermal drug delivery through pores created in the stratum corneum. AIM: To evaluate the efficacy of microneedling with tacrolimus versus its efficacy with calcipotriol plus betamethasone in vitiligo treatment. METHODS Twenty-five patients having vitiligo were selected and their symmetrical patches were divided into side A (right side) which received microneedling with dermapen and topical calcipotriol plus betamethasone and side B (left side) which received microneedling and topical tacrolimus. Every patient received a session every 2 weeks for a maximum 6 months (12 sessions) and follow-up for 3 months. Skin biopsies were taken before and after the treatment to evaluate the clinical results. RESULTS On side A, 60% of the patients showed excellent improvement while 32% showed excellent response on side B. The mean percentage of improvement was significantly higher on side A than side B (P = 0.017* ). It was effective in the most resistant sites of vitiligo such as: elbows, knees, extremities, and acral area. Histopathological examination showed a significant expression of HMB45 on side A more than side B (P = 0.005* ). CONCLUSION The combination of microneedling with calcipotriol plus betamethasone is more effective than its combination with tacrolimus. They are both effective in resistant sites. Both methods are safe, cheap, and good tolerated office techniques with minimal side effects.
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Ixekizumab treatment shows a neutral impact on cardiovascular parameters in patients with moderate-to-severe plaque psoriasis: Results from UNCOVER-1, UNCOVER-2, and UNCOVER-3.
Egeberg, A, Wu, JJ, Korman, N, Solomon, JA, Goldblum, O, Zhao, F, Mallbris, L
Journal of the American Academy of Dermatology. 2018;(1):104-109.e8
Abstract
BACKGROUND The impact of ixekizumab treatment for psoriasis on cardiovascular-related parameters in patients is unknown. OBJECTIVE To investigate cardiovascular-related parameters in patients with psoriasis treated with ixekizumab. METHODS In phase 3 trials, patients with moderate-to-severe psoriasis were randomized and treated with placebo, ixekizumab, or etanercept during the induction period (weeks 0-12; UNCOVER-1, UNCOVER-2, and UNCOVER-3). At week 12, responders were rerandomized to receive placebo or ixekizumab through the maintenance period (weeks 12-60; UNCOVER-1 and UNCOVER-2). Laboratory measures (fasting lipid profiles, glucose level, or high-sensitivity C-reactive protein [hsCRP] level), weight, blood pressure, and electrocardiograms were obtained through 60 weeks. RESULTS Baseline parameters were within normal ranges with the exception of elevated triglyceride and hsCRP levels. After maintenance dosing, no significant changes were observed versus placebo for total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, triglyceride, apolipoprotein A1, apolipoprotein B, or fasting glucose levels or for systolic/diastolic blood pressure at 60 weeks. Importantly, low-density lipoprotein-to-high-density lipoprotein ratios remained stable during the induction and maintenance periods. HsCRP concentrations were significantly reduced versus placebo at 12 weeks and remained reduced at 60 weeks, although not significantly. Although transient changes were observed for some parameters during the induction period, these changes did not persist into the maintenance period. LIMITATIONS A lack of echocardiogram evaluations. CONCLUSIONS Ixekizumab had a neutral impact on cardiovascular-related parameters in patients with psoriasis.
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Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam in Patients with Moderate-to-Severe Psoriasis: Sub-Group Analysis of the PSO-ABLE Study.
Paul, C, Leonardi, C, Menter, A, Reich, K, Gold, LS, Warren, RB, Møller, A, Lebwohl, M
American journal of clinical dermatology. 2017;(3):405-411
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Abstract
BACKGROUND Fixed-combination calcipotriol 50 μg/g plus betamethasone 0.5 mg/g (Cal/BD) aerosol foam is a new topical treatment for psoriasis. Although moderate-to-severe psoriasis is typically treated with systemic/biologic therapies, a topical treatment that is efficacious in these patients may be a significant cost-saving alternative to systemic therapy. OBJECTIVE The objective of this study was to assess the response to Cal/BD foam and gel in patients with moderate-to-severe psoriasis enrolled in the phase III, 12-week PSO-ABLE study. METHODS Patients eligible for this analysis had moderate-to-severe psoriasis, defined by the 'Rule of Tens': body surface area ≥10% or Psoriasis Area and Severity Index (PASI) [excluding head; modified PASI (mPASI)] >10 or Dermatology Life-Quality Index >10. Endpoints included: proportion of patients achieving mPASI75 or mPASI90; change in body surface area; proportion of patients clear/almost clear with a ≥2 grade improvement (i.e., treatment success); change in Dermatology Life-Quality Index. RESULTS Seventy-seven Cal/BD foam patients and 82 gel patients had moderate-to-severe psoriasis. A greater proportion achieved mPASI75 and mPASI90 with Cal/BD foam than gel at weeks 4, 8, and 12 (57.1 vs. 35.4%; p = 0.006 and 15.6 vs. 12.2% at week 12, respectively); overall reduction in mPASI from baseline to week 12 was 64% with the foam vs. 51% with the gel. Overall reduction in body surface area at week 12 was 50% with the foam and 39% with the gel. Treatment success rates were higher with the Cal/BD foam than the gel at weeks 1, 2, 4, 8 (p = 0.0089), and 12, and a greater proportion of foam patients achieved a Dermatology Life-Quality Index score of 0/1 at weeks 4 (p = 0.004), 8, and 12 (p = 0.001). CONCLUSION Cal/BD foam can be considered as a treatment option in some patients with moderate-to-severe psoriasis who are potential candidates for systemic therapy. CLINICALTRIALS. GOV IDENTIFIER NCT02132936.
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Fixed combination calcipotriol plus betamethasone dipropionate aerosol foam in the treatment of psoriasis vulgaris: rationale for development and clinical profile.
Paul, C, Bang, B, Lebwohl, M
Expert opinion on pharmacotherapy. 2017;(1):115-121
Abstract
Psoriasis is a chronic, immune-mediated inflammatory disorder with a significant negative impact on quality of life. Most patients with mild-to-moderate psoriasis manage their disease with topical therapies; the most commonly used formulations contain corticosteroids and/or vitamin D3 analogues. However, adherence to topical treatment remains a significant issue as the daily treatment regimen can be cumbersome and time consuming and many patients do not obtain complete/almost complete clearance. Areas covered: Published pre-clinical and clinical data evaluating calcipotriol 50 µg/g (Cal) and betamethasone 0.5 mg/g as dipropionate (BD) aerosol foam in patients with psoriasis. Expert opinion: Cal/BD aerosol foam, a once-daily, alcohol-free, paraffin-based vehicle with emollient properties, was developed to increase the therapeutic options available to patients. Cal/BD aerosol foam is rapidly effective for treating psoriasis and the greater efficacy compared with the ointment and gel formulations is consistent and clinically relevant. This enhanced efficacy is due to improved skin penetration of the active ingredients following the formation of a stable supersaturated solution on the skin. Studies have shown increasing patient satisfaction with Cal/BD aerosol foam. It is hoped that this optimized formulation of Cal/BD will improve adherence and help to address the unmet medical needs of patients with mild-to-moderate psoriasis.
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Superior Efficacy of an Herbal-based Cosmeceutical Compared With Common Prescription and Cosmetic Antiaging Therapies.
Thornfeldt, CR, Rizer, RL
Journal of drugs in dermatology : JDD. 2016;(2):218-23
Abstract
INTRODUCTION Research has shown that a disrupted stratum corneum permeability barrier coupled with chronic inflammation induce signs of extrinsic aging (photoaging). An novel herbal-based three product cosmeceutical regimen used to reverse these two anomalies that does not contain retinol, soy, niacinamide, tea, L-ascorbic acid or esters, hydroxy acids, tocopherol, or growth factors was tested in six human clinical trials to determine effectiveness and safety in reversing photoaging. MATERIALS AND METHODS Six randomized split face, double blind, prospective, controlled clinical trials involving a total of 110 subjects compared a cosmeceutical blend of novel herbs in regimens consisting of one to three products to several common antiaging topical treatments. These comparative products include prescription tretinoin, physician strength idebenone, kinetin, polyhydroxy, lactic and glycolic acids in reversing signs of photoaging. RESULTS The novel cosmeceutical blend regimen showed superior efficacy and safety in all six trials. DISCUSSION These trials substantiate that herbs not used in common antiaging products effectively and safely mitigate and reverse photoaging signs and symptoms. The novel concept of treating photoaging and preventing its progression by repairing and optimizing the stratum corneum barrier, while reversing and inhibiting chronic cutaneous inflammation, has now been proven.
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Dr Michaels® product family (also branded as Soratinex®) versus Methylprednisolone aceponate - a comparative study of the effectiveness for the treatment of plaque psoriasis.
Hercogovấ, J, Fioranelli, M, Gianfaldoni, S, Chokoeva, AA, Tchernev, G, Wollina, U, Tirant, M, Novotny, F, Roccia, MG, Maximov, GK, et al
Journal of biological regulators and homeostatic agents. 2016;(2 Suppl 3):77-81
Abstract
As one of the most common dermatologic chronic-recurrent disease, variable therapeutic options are available today for management of psoriasis. Although topical high potency corticosteroids, alone or in association with salicylic acid or vitamin D analogues, are still considered the best treatment, they do not seem to possess the capability for a long-term control of the disease or prevent recurrences, as their side effects are major contraindications for continuative use. The aim of this study was to investigate whether Dr. Michaels® product family is comparable to methylprednisolone aceponate (MPA) as a viable alternative treatment option for the treatment and management of stable chronic plaque psoriasis. Thirty adults (13 male, 17 female, mean age 40 years) with mild to severe stable chronic plaque psoriasis, were included in the study. Patients were advised to treat the lesions of the two sides of their body (left and right) with two different unknown modalities for 8 weeks; the pack of Dr. Michaels® products on the left side (consisting of a cleansing gel, an ointment and a skin conditioner) and a placebo pack on the right side, consisting of a cleansing gel, methylprednisolone ointment and a placebo conditioner. Assessment was done using the Psoriasis Activity Severity Index (PASI) scores before treatment and after 2, 4, 6 and 8 weeks. The results achieved with the Dr. Michaels® (Soratinex®) product family for the treatment of chronic plaque psoriasis were better than the results achieved with methylprednisolone aceponate (MPA), even though quicker resolution was achieved with the steroid with 45% of patients achieving resolution within 8-10 days in comparison to 5-6 weeks in the Dr. Michaels® (Soratinex®) group. Before therapy, the mean PASI score of the LHS in Dr. Michaels® (Soratinex®) group was 13.8±4.1 SD and 14.2±4.2 SD in the RHS methylprednisolone aceponate (MPA) group. After 8 weeks of treatment 62% of the Dr. Michaels® (Soratinex®) group had achieved resolution whilst in the methylprednisolone aceponate (MPA) group, the figure remained at 45%. The mean PASI score after 8 weeks of treatment was calculated and in the LHS Dr. Michaels® (Soratinex®) group it was 2.8±1.6 SD and 6.8±2.4 SD in the RHS methylprednisolone aceponate group. In the RHS -methylprednisolone aceponate (MPA) group, 22% of patients failed to respond to the treatment in comparison to 6% in the LHS Dr. Michaels® (Soratinex®) group. Based on the results of this study, Dr. Michaels® products are a more effective treatment option, with insignificant side effects, compared to local treatment with methylprednisolone aceponate (MPA).
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Inositol and acne.
Pezza, M, Carlomagno, V, Casucci, G
Giornale italiano di dermatologia e venereologia : organo ufficiale, Societa italiana di dermatologia e sifilografia. 2015;(6):649-53
Abstract
Acne, once considered as a mere esthetic problem, is now recognized as a disease that can cause major disturbances of the psychological and emotional sphere. Currently, the treatment of acne is focused on one or more pathogenic factors: hormonal stimulation and sebaceous hypersecretion, disorder of keratinization, colonization of Propionibacterium acnes and inflammation. The aim of the paper was to evaluate the use of inositol in patients with moderate acne.