The effect of dilution of fusidic acid cream and betamethasone dipropionate cream in complex extemporaneous mixes on formulation performance.

The Aron regimen is an unconventional therapy which entails frequent applications of an extemporaneously prepared three component system (a topical antibiotic, a corticosteroid and an emollient), with the intention of decolonising the skin of S. aureus whilst treating atopic dermatitis. The impact of heavily diluting these topical medicinal products, to differing extents, on formulation performance is not well understood thus was investigated in this study. Following a single application of a range of compounded Aron mixes (fusidic acid and betamethasone dipropionate diluted to varying extents in an emollient base), significant reductions in the expected drug flux across silicone membrane, ex vivo percutaneous absorption and skin retention of both drugs relative to the marketed products were observed. This was attributed to a number of complex formulation effects making such changes difficult to predict in a clinical setting. Further investigations are required to evaluate the impact of frequent applications of the Aron mix to widespread areas on clinical efficacy, antimicrobial resistance and long term side effects.

The continued inappropriate use and overuse of combination topical clotrimazole-betamethasone.

OBJECTIVE: Combination topical clotrimazole/ betamethasone dipropionate (C-BM) contains a high-potency topical corticosteroid and is not infrequently prescribed for inappropriate patient groups and body sites. Use of C-BM can lead to inadequate clearance or exacerbation of fungal infections as well as cutaneous atrophy, striae, and other skin maladies. METHODS: We performed a retrospective chart review of 1,978 clinical visits where C-BM was prescribed within the University of Utah Health system between 2014 and 2018 to better understand current prescribing patterns. RESULTS: 1,974 prescriptions were written for C-BM. 91.6% of patients were at least the recommended age of 17 years. C-BM was most commonly prescribed for rashes of an inflammatory (42.2%) or fungal nature (38.1%). Clotrimazole/betamethasone dipropionate was prescribed for sensitive areas (face, axillae, groin or diaper region) in 48.9% of patients. Family medicine clinicians prescribed 58.3% of C-BM prescriptions, whereas dermatology clinicians accounted for 3.4%. CONCLUSION: We strongly recommend clinicians use alternative treatments for rashes or refer to dermatologists.

Calcipotriol/betamethasone dipropionate foam demonstrates comparable efficacy to clinical trial data in the real world, improves patient satisfaction and is cost-effective.

Real-world evidence studies are becoming increasingly important in providing insight into clinical effectiveness and safety, economic outcomes, patient-reported outcomes and health-related quality of life of treatments in the clinical setting. These studies also help to complement data reported in clinical studies. Fixed-dose combination calcipotriol 50 µg/g plus betamethasone dipropionate 0.5 mg/g cutaneous foam (Cal/BD foam) is a topical agent used for the treatment of psoriasis vulgaris. In clinical studies, Cal/BD foam has demonstrated a significantly greater efficacy and rapid onset of action compared with both single and combination formulations such as ointments and gels. To date, three observational studies have examined the real-world efficacy and safety of Cal/BD foam in clinical practice in the United States, Germany and Spain. Data gathered from these studies reinforce the positive findings reported in clinical studies assessing Cal/BD foam for the treatment of psoriasis and demonstrate improved patient satisfaction with Cal/BD foam. Using Cal/BD foam has been shown to be cost-effective based on results from randomised clinical trials and cost-effective analysis. As such, Cal/BD foam has the potential to lower treatment costs by reducing the need for some patients to progress to more expensive treatments, such as phototherapy and biologics. Cal/BD foam is therefore a cost-effective solution for the treatment of psoriasis vulgaris that should be considered when prescribing topicals.

Efficacy of topical calcipotriol betamethasone dipropionate as a new adjuvant therapy to follicular unit extraction technique in treatment of stable vitiligo: clinical, dermoscopic and immunohistological study.

BACKGROUND: Follicular unit extraction (FUE) grafting is a surgical procedure which provides the vitiliginous patches with undifferentiated stem cells of the hair follicles. It has been postulated that adjuvant therapy enhances the results. This is the first study to assess two different adjuvant therapies vs FUE alone. AIMS: To study the efficiency of FUE alone or combined with either topical calcipotriol betamethasone dipropionate (CBD) or NB-UVB phototherapy in cases of nonsegmental stable vitiligo. To assess the role of dermoscopy in monitoring the pattern and degree of repigmentation. PATIENTS/ METHODS: 53 patients with 94 lesions with stable nonsegmental vitiligo were divided into three groups. Group 1 (n = 16) with 30 lesions received FUE alone. Group 2 (n = 18) with 32 lesions received FUE plus topical CBD. Group 3 (n = 19) with 32 lesions received FUE plus NB-UVB phototherapy. Assessment was done by grades of repigmentation, color match, percent of size reduction, and immunohistochemical evaluation of perilesional CD8+T lymphocytes. RESULTS: The fastest onset of repigmentation was observed in both groups 2 and 3 in the second week (16.7%, 10.5%, respectively).Group 2 achieved the best response by all methods of assessment. Perifollicular diffuse repigmentation was the commonest dermoscopic pattern in 60 lesions (63.8%). There was a statistically significant decrease in perilesional CD8+T lymphocytes after 4 months. CONCLUSION: FUE is an effective method of surgical treatment of stable vitiligo, and topical CBD as a new adjuvant therapy is successful in targeting the immunological background of vitiligo. Dermoscopy has an essential role in monitoring the repigmentation response.

Development and characterization of a human Th17-driven ex vivo skin inflammation model.

Skin models mimicking features of psoriasis-related inflammation are needed to support the development of new drugs in dermatology. Reconstructed skin models lack tissue complexity, including a fully competent skin barrier, and presence and/or diversity of immune cells. Here, we describe InflammaSkin®, a novel human Th17-driven ex vivo skin inflammation model. In this model, skin-resident T cells are in situ activated by intradermal injection of anti-CD3 and anti-CD28 antibodies and Th17 cell polarization is sustained by culture in a chemically defined medium supplemented with IL-1ß, IL-23 and TGF-ß for seven days. The acquired Th17 signature is demonstrated by the sustained secretion of IL-17A, IL-17AF, IL-17F, IL-22, IFN-γ, and to some degree IL-15 and TNF-α observed in the activated ex vivo skin inflammation model compared with the non-activated skin model control. Furthermore, expression of S100A7 and Keratin-16 by keratinocytes and loss of epidermal structure integrity occur subsequently to in situ Th17cell activation, demonstrating cellular crosstalk between Th17 cells and keratinocytes. Finally, we demonstrate the use of this model to investigate the modulation of the IL-23/IL-17 immune axis by topically applied anti-inflammatory compounds. Taken together, we show that by in situ activation of skin-resident Th17 cells, the InflammaSkin® model reproduces aspects of inflammatory responses observed in psoriatic lesions and could be used as a translational tool to assess efficacy of test compounds.

Conservative Treatment Versus Ultrasound-Guided Injection in the Management of Meralgia Paresthetica: A Randomized Controlled Trial.

BACKGROUND: Meralgia paresthetica (MP) is an entrapment mononeuropathy of the lateral femoral cutaneous nerve (LFCN), in which conservative treatment options are not always sufficient. OBJECTIVES: The aim of this study was to evaluate the efficacy of ultrasound (US)-guided LFCN injection in the management of MP by comparing with transcutaneous electrical nerve stimulation (TENS) therapy and sham TENS therapy. STUDY DESIGN: A prospective, randomized, sham-controlled study. SETTING: Health Sciences University Training and Research Hospital in Turkey. METHODS: Patients diagnosed with LFCN compression with clinical and electrophysiological findings were included in this study. Patients were randomly assigned to 3 groups: (1) US-guided injection group, (2) TENS group, and (3) sham TENS group. The blockage of the LFCN was performed for therapeutic MP management in group 1. Ten sessions of conventional TENS were administered to each patient 5 days per week for 2 weeks, for 20 minutes per daily session in group 2, and sham TENS was applied to group 3 with the same protocol. Visual Analog Scale (VAS), painDETECT questionnaire, Semmes-Weinstein monofilament test (SWMt), Pittsburgh Sleep Quality Index (PSQI), and health-related quality of life (36-Item Short Form Health Survey [SF-36]) at onset (T1), 15 days after treatment (T2), and 1 month after treatment (T3) were used for evaluation. Patients and the investigator who evaluated the results were blinded to the treatment protocol during the study period. RESULTS: A total of 54 of the 62 patients (group 1 n = 17, group 2 n = 16, group 3 n = 21) completed the study, 3 patients from group 1, 4 patients from group 2, and 1 patient from group 3 dropped out during the follow-up period. The mean changes in painDETECT and SWMt scores showed a statistically significant difference between groups in favor of group 1 at T2 and T3 compared with T1 (P < 0.05). There was no statistically significant difference between groups in terms of VAS, SF-36, and PSQI scores (P > 0.05). In-group analysis of VAS scores showed a statistically significant decrease in T2 and T3 compared with T1 in group 1 (P < 0.05). In-group analysis of the VAS scores statistically significant decrease was shown in T2 compared with T1 in group 2 (P < 0.05). In-group analysis of painDETECT scores statistically significant decrease was shown in T2 and T3 compared with T1 in all groups (P < 0.05). In-group analysis of SWMt scores statistically significant decrease was shown in T2 and T3 compared with T1 in group 1 (P < 0.05). In-group analysis of SF-36 and PSQI scores, there was no statistically significant decrease in all groups (P > 0.05). LIMITATIONS: The limitation of the study was a short follow-up period. CONCLUSIONS: US-guided LFCN injection and TENS may be therapeutic options for MP treatment, however, for patients with neuropathic pain symptoms, US-guided LFCN injection may be a safe and alternative method to conservative treatment. KEY WORDS: Meralgia paresthetica, ultrasound-guided injection, transcutaneous electrical nerve stimulation.

Comparison of corticosteroid injection and ozone injection for relief of pain in chronic lateral epicondylitis.

To evaluate and compare the therapeutic effects of corticosteroid and ozone injections in the alleviation of pain associated with chronic lateral epicondylitis . Data was collected from the medical records of 80 patients (56 women, 24 men ; average age : 45.8±7.5). Corticosteroid injection was performed once a week for three times, and ozone was injected 6-8 times at 3 day intervals. No additional analgesics were given. Pain assessment was made by means of Verhaar scores before and after the first injection, on 3rd, 6th and 9th months. The duration of pain was 24.4±12.5 months and the right side was more commonly affected (47, 58.8% vs. 33, 41.2%). Corticosteroid and ozone groups were similar with respect to age (p=0.45), gender distribution (p=0.43) and side of epicondylitis (p=0.88). Pain scores at rest, at compression and on activity were not different in two groups before and following injection. Notably, ozone group displayed better scores compared to corticosteroid in terms of pain on 3rd, 6th and 9th months after injection (p<0.001 for all). Our results demonstrated that ozone injection can be an effective therapeutic option for CLE patients who are refractory to conservative treatment.

A Cost-utility Analysis of Calcipotriol/Betamethasone Dipropionate Aerosol Foam versus Ointment for the Topical Treatment of Psoriasis Vulgaris in Sweden.

Psoriasis is a chronic inflammatory disorder that imposes a substantial economic burden. We conducted a cost-utility analysis from a Swedish healthcare payers perspective using a decision-tree model with a 12-week time horizon. Patients with psoriasis vulgaris could have two 4-week cycles of topical treatment with calcipotriol 50 µg/g and betamethasone 0.5 mg/g as dipropionate (Cal/BD) foam or Cal/BD ointment before progressing to phototherapy/methotrexate. In the base-case analysis, Cal/BD foam dominated over Cal/BD ointment. The increased efficacy of Cal/BD foam resulted in fewer consultations and a decreased risk of progressing to phototherapy/methotrexate. Although Cal/BD foam costs more than Cal/BD ointment, this was offset by lower costs for phototherapy/methotrexate or consultation visits. Sensitivity analyses revealed that the base-case net monetary benefit was robust to plausible variations in key parameters. In conclusion, Cal/BD foam was predicted to be more cost-effective than Cal/BD ointment in the treatment of psoriasis vulgaris.

Calcipotriol/betamethasone ointment compared to narrow-band UVB in plaque psoriasis: first clinical and ultrasonographic study.

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.

Novel hydrogel-based ocular drug delivery system for the treatment of conjunctivitis.

PURPOSE: Conventional dosage form like eye drops showed poor therapeutic response and also require frequent dosing. Therefore, developing the dosage form to deliver the drug to the target site without much loss of drug or without causing any systemic side effects is the challenging job for the researchers in pharmaceutical industries. OBJECTIVE: The main aim of the present work was to formulate and evaluate hydrogel-based drug delivery containing combination of neomycin sulphate and betamethasone sodium phosphate in order to provide prolonged release and also better bioavailability of drugs for the treatment of eye infections. METHODS: In this study, poloxamer 407 and chitosan at different concentrations were used as the gelling agents. The prepared formulations were evaluated for clarity, pH, drug content, gelling capacity, gelling temperature and in vitro drug release study. RESULTS: From the preliminary studies, F5 formulation was selected as an optimized formulation. The optimized formulation was further evaluated for ex vivo permeation study, sterility test, HET-CAM and ocular irritation testing using rabbits. Ocular irritation by HET-CAM assay showed that the formulated gel does not cause any irritation to the blood vessels. Draize irritation test was performed using rabbits and results showed that formulation was non-irritant to the eye. CONCLUSION: The formulated hydrogel formulation can be used as an alternative to conventional ophthalmic eye drop formulation of drugs neomycin and betamethasone for the purpose of providing prolonged therapy for the treatment of conjunctivitis.

A Prospective, Open-Label Study Evaluating Adjunctive Calcipotriene 0.005%/Betamethasone Dipropionate 0.064% Foam in Psoriasis Patients With Inadequate Response to Biologic Therapy.

OBJECTIVE: To assess the effectiveness and safety of combining calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam with biologic therapies for patients with plaque psoriasis who have not obtained an adequate response with biologic therapy. METHODS: This was a prospective, open-label, single-arm study of patients with chronic plaque-type psoriasis (body surface area [BSA] ≤5%) who were being treated with biologic agents for ≥24 weeks. All patients received once-daily Cal/BD foam for 4 weeks, followed by twice-weekly use on consecutive days for 12 weeks (maintenance regimen). The end points were assessed at weeks 4 and 16, and included the Physician's Global Assessment (PGA), BSA, PGA×BSA, Dermatology Life Quality Index (DLQI), and Treatment Satisfaction Questionnaire for Medication (TSQM)-9. Safety evaluations included assessments of local skin reactions and adverse events (AEs). RESULTS: Enrolled were 25 patients (18 men and 7 women; mean age, 53 ± 11 years). Patients had significant disease activity despite being on stable biologic therapy (median values: BSA, 3%; PGA, 3; PGA×BSA, 8). At weeks 4 and 16 versus baseline, adjunctive therapy with Cal/BD foam significantly improved PGA score (1 vs 1 vs 3; P less than .01), BSA involvement (1% vs 1% vs 3%; P less than .01), and PGA×BSA measure (1 vs 1 vs 8; P less than .01). Most patients achieved treat-to-target criteria for BSA ≤1% and PGA ≤1 at week 4 (both 76%) and week 16 (both 68%) versus 12% and 4%, respectively, at baseline. Quality of life was improved at both weeks 4 and 16, with high treatment satisfaction. Overall, adjunctive Cal/BD foam was safe and well-tolerated, with no serious AEs. CONCLUSIONS: Adjunctive therapy with Cal/BD foam was associated with an improvement of every measure of disease activity in patients with inadequate response to biologics, an effect that was maintained throughout the study. The majority of patients achieved treat-to-target goals. J Drugs Dermatol. 2018;17(8):845-850.

Differential effects of phototherapy, adalimumab and betamethasone-calcipotriol on effector and regulatory T cells in psoriasis.

BACKGROUND: Psoriasis is a chronic T-cell-mediated skin disease with marked social and economic burdens. Current treatments are unsatisfactory, with unpredictable remission times and incompletely understood modes of action. Recent advances in our understanding of the pathogenesis of psoriasis have identified the imbalance between CD4+ T effector cells, particularly the T helper (Th)17 subset, and regulatory T cells (Tregs) as key to the development of psoriatic lesions, and therefore a novel therapeutic target. OBJECTIVES: To quantify in patients the effects of three commonly used psoriasis treatment modalities on the Th1, Th2, Th17 and Treg subsets, and to test whether any change correlates with clinical response. METHODS: Flow cytometry was used to enumerate Th1, Th2, Th17 and Treg subsets in blood and skin of patients with psoriasis before and after receiving any of the following treatments: narrowband ultraviolet B (NB-UVB), adalimumab and topical betamethasone-calcipotriol combination (Dovobet® ) RESULTS: All patients responded clinically to the treatments. NB-UVB significantly increased the numbers of circulating and skin Tregs, while, by contrast, adalimumab reduced Th17 cells in these compartments, and Dovobet had dual effects by both increasing Tregs and reducing Th17 cells. CONCLUSIONS: The differential effects reported here for the above-mentioned treatment modalities could be exploited to optimize or design therapeutic strategies to overcome the inflammatory drivers more effectively and restore the Th17-Treg balance in psoriasis.

Back to the future: a new topical approach for mild-to-moderate psoriasis.

Psoriasis is a chronic-relapsing skin disorder which requires long-term treatments. Therapeutic options for psoriasis include topical treatments, phototherapy and systemic therapy. However, those treatments, and particularly the topical drug therapies, may present some limitations, including poor efficacy/tolerability ratio and lack of adherence. Recently, the supersaturated aerosol foam formulation of the fixed combination calcipotriene plus betamethasone dipropionate (Cal/BD) has gained major attention because it overcomes some of the limitations associated with other topical treatments. This fixed-combination has increased efficacy compared with its individual components. Moreover, the alcohol-free aerosol foam formulation allows a higher penetration of the active ingredients into the skin, resulting in enhanced bioavailability and, consequently, in better clinical outcomes than other products with the same components. Given the short duration of therapy course and the fast onset of action, a reduced amount of Cal/BD foam formulation would be required for the treatment of psoriasis patients, resulting also in cost saving. Therefore this novel formulation could represent an alternative to other topical agents and a first-line therapy in the treatment of mild and mild-to-moderate psoriasis.

Calcipotriene betamethasone dipropionate aerosol foam in the treatment of plaque psoriasis: a review of the literature.

Psoriasis is a common chronic immune-mediated skin disease which has a significant impact on patients' quality of life, and is associated with numerous comorbidities (i.e., psoriatic arthritis, Crohn's disease and cardiovascular disease). A greater understanding of its immunopathogenesis has guided the development of novel, more targeted therapies. Nonetheless, traditional treatment with topical agents, phototherapy and systemic medications is used in the management of the majority of psoriasis patients. Mainstay topical treatments include corticosteroids and vitamin D derivatives. Calcipotriene/betamethasone dipropionate aerosol foam is a novel single product combination, which seeks to provide superior therapeutic efficacy in addition to enhanced cosmetic properties. This article reviews the literature on the pharmacology and clinical data in terms of safety, efficacy and patient satisfaction of this topical medication.

The cost-effectiveness of blue-light therapy in the treatment of mild-to-moderate psoriasis.

AIM: To investigate the cost-effectiveness of blue-light therapy versus a two-compound formulation (TCF) (Dovobet® gel [calcipotriol and betamethasone]) in mild-to-moderate psoriasis. METHODS: A Markov model was applied to describe the course of disease among Dutch patients with a Psoriasis Area and Severity Index (PASI) score ≤ 10 over a 52-week time horizon. Patients received either 12-week blue-light therapy or two 4-week treatments with TCF. Patients, experiencing no PASI reduction after either therapy, were assumed to receive 12-week ultraviolet B phototherapy. RESULTS: There was no significant difference in PASI reduction between two interventions (71 vs 72%). However, blue-light therapy was associated with a cost savings of EU€248. CONCLUSION: Treatment of mild-to-moderate chronic plaque psoriasis using blue-light therapy may be more cost-effective than TCF.

Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam in Patients with Moderate-to-Severe Psoriasis: Sub-Group Analysis of the PSO-ABLE Study.

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.

Association of Borage Oil and Betamethasone Dipropionate in Lipid-Core Nanocapsules: Characterization, Photostability and In Vitro Irritation Test.

The association of vegetable products to nanostructured systems has attracted the attention of researchers due to several advantages, such as drug photoprotection, as well as the improvement of the pharmacological and therapeutic activities because of synergistic action, which can provide their topical application. In this work, lipid-core nanocapsules containing borage oil as oil core and betamethasone dipropionate were developed, and nanocapsules without the drug were prepared for comparison. The suspensions were characterized in relation to mean particle size, zeta potential, pH, drug content, and encapsulation efficiency. A photodegradation study was carried out and the in vitro release profile as well as the irritation potential of the drug after nanoencapsulation were also evaluated. In addition, the antiproliferative activity of the free borage oil as well as loaded in nanocapsules was studied. Lipid-core nanocapsules showed nanometric mean size (185-210 nm); polydispersity index below 0.10; negative zeta potential and pH slightly acid (6.0-6.2). Moreover, the drug content was close to theoretical concentration (0.50 +/- 0.03 mg/ml of betamethasone), and the encapsulation efficiency was approximately 100%. The study of the antiproliferative activity of borage oil showed ability to reduce cell growth of Allium cepa. The nanoencapsulation of betamethasone dipropionate provided greater protection against UVC light and decreased the irritation potential of the drug. The release profile of betamethasone dipropionate from nanocapsules followed monoexponential model.

Topical betamethasone butyrate propionate exacerbates pressure ulcers after cutaneous ischemia-reperfusion injury.

Ischaemia-reperfusion (I/R) is involved in the development of various organ diseases. There has been increasing evidence that cutaneous I/R injury is associated with the pathogenesis of pressure ulcers (PUs), especially at the early stage presenting as non-blanchable erythema. However, there is no evidence-based treatment for early-stage PUs. Our objective was to assess the effects of topical steroid on the development of PUs after cutaneous I/R injury in mice. Cutaneous I/R was performed by trapping the dorsal skin between two magnetic plates for 12 h, followed by plate removal. Topical application of betamethasone butyrate propionate (BBP) in I/R areas significantly increased the size of PUs after I/R. The number of thromboses was increased, and CD31(+) vessels were decreased in the I/R area treated with topical BBP. The number of oxidative stress-associated DNA-damaged cells and apoptotic cells in the I/R area was increased by topical BBP treatment. In addition, the mRNA level of NADPH oxidase 4 (Nox4), the essential enzyme that produces reactive oxygen species, was significantly increased and that of NF-E2-related factor 2 (Nrf2), a transcription factor that regulates the expression of antioxidant proteins, was inhibited in the I/R area treated by BBP. The number of CD68(+) macrophages and the level of transforming growth factor-beta in lesional skin were also decreased by BBP. These results suggest that a topical steroid might accelerate the formation of PUs induced by cutaneous I/R injury by aggravating oxidative stress-induced tissue damage. Topical steroids might not be recommended for the treatment of acute-phase decubitus ulcers.

Oral PSORI-CM01, a Chinese herbal formula, plus topical sequential therapy for moderate-to-severe psoriasis vulgaris: pilot study for a double-blind, randomized, placebo-controlled trial.

BACKGROUND: To provide evidence that the Chinese herbal medicine (CHM) PSORI-CM01 combined with Western medicine reduces the relapse rate of psoriasis vulgaris (PV), we plan to conduct a large-scale randomized control trial (RCT). In order to improve and perfect the RCT, this pilot study was designed to determine the feasibility and the potential of a modified protocol for the full-scale RCT. METHODS: Eligible patients with psoriasis vulgaris (PV) were enrolled into a randomized comparison in which all subjects received topical sequential therapy and PSORI-CM01 or placebo for 12 weeks. The primary outcome measure was the relapse rate. Treatment response was computed from Psoriasis Area and Severity Index (PASI), body surface area (BSA), and Dermatology Life Quality Index (DLQI). The secondary outcome measures included time to relapse, time to onset, rebound rate, PASI score, pruritus scores on the Visual Analog Scale (VAS), BSA, DLQI and SF-36 (short form health survey), and incidence of serious adverse events (SAEs). RESULTS: Six of 7 (86 %) subjects reached the PASI-50 in the CHM group compared with nine of 10 (90 %) in the placebo group during the treatment period. Among the subjects who reached PASI-50, one out of six subjects (17 %) relapsed in the CHM group during the treatment period compared with six out of nine patients in the placebo group (67 %). No subjects met the rebound criteria. Changes to baseline in the PASI scores were not significantly different between the two groups (t = 1.764, P = 0.098). CONCLUSION: Oral PSORI-CM01 combined with topical sequential treatment showed a smaller recurrence rate (P = 0.118) than placebo combined with the same topical therapy for moderate-to-severe PV in this pilot study. TRIAL REGISTRATION: Chinese Clinical Trial Registry ( http://www.chictr.org.cn/searchproj.aspx ) ChiCTR-TRC-13003233 ; date of registration: 15 April 2013.