Prospects for the convergence of polyphenols with pharmaceutical drugs in Type 2 Diabetes: challenges, risks, and strategies.

Type 2 diabetes mellitus (T2DM) is a complex disease that can lead to a variety of life-threatening secondary health conditions. Current treatment strategies primarily revolve around tight glucose control that is difficult to achieve and often turns out to be dangerous due to possible hypoglycemic events. Numerous long-term studies have demonstrated that complex pathways, including low-grade inflammation due to fluctuating glucose levels, are involved in the progression of the disease and the development of secondary health conditions. Growing clinical evidence supports the effectiveness of using multiple medications, possibly in combination with insulin, to effectively manage T2DM. On the other hand, despite the huge, largely untapped potential therapeutic benefit of 'polyphenols', there remains a general skepticism of the practice. However, for any evidence-based clinical intervention, the balance of benefits and risks takes center stage and is governed by biopharmaceutics principles. In this article, we outline the current clinical perspectives on pharmaceutical drug combinations, rationale for early initiation of insulin, and the advantages of novel dosage forms to meet the pathophysiological changes of T2DM, emphasizing the need for further clinical studies to substantiate these approaches. We also make the case for traditional medicines and their combinations with pharmaceutical drugs and outline the inherent challenges in doing so, while also providing recommendations for future research and clinical practice. Significance Statement Type 2 diabetes is associated with life-threatening secondary health conditions that are often difficult to treat. This review provides an in-depth account of preventing/delaying secondary health conditions through combination therapies and emphasizes the role of effective delivery strategies in realizing the translation of such combinations. We will build the case for the importance of polyphenols in diabetes, determine the reasons for skepticism, and potential combinations with pharmaceutical drugs.

Leveraging Lymphatic System Targeting in Systemic Lupus Erythematosus for Improved Clinical Outcomes.

The role of advanced drug delivery strategies in drug repositioning and minimizing drug attrition rates, when applied early in drug discovery, is poised to increase the translational impact of various therapeutic strategies in disease prevention and treatment. In this context, drug delivery to the lymphatic system is gaining prominence not only to improve the systemic bioavailability of various pharmaceutical drugs but also to target certain specific diseases associated with the lymphatic system. Although the role of the lymphatic system in lupus is known, very little is done to target drugs to yield improved clinical benefits. In this review, we discuss recent advances in drug delivery strategies to treat lupus, the various routes of drug administration leading to improved lymph node bioavailability, and the available technologies applied in other areas that can be adapted to lupus treatment. Moreover, this review also presents some recent findings that demonstrate the promise of lymphatic targeting in a preclinical setting, offering renewed hope for certain pharmaceutical drugs that are limited by efficacy in their conventional dosage forms. These findings underscore the potential and feasibility of such lymphatic drug-targeting approaches to enhance therapeutic efficacy in lupus and minimize off-target effects of the pharmaceutical drugs. SIGNIFICANCE STATEMENT: The World Health Organization estimates that there are currently 5 million humans living with some form of lupus. With limited success in lupus drug discovery, turning to effective delivery strategies with existing drug molecules, as well as those in the early stage of discovery, could lead to better clinical outcomes. After all, effective delivery strategies have been proven to improve treatment outcomes.

Bone mineral density, vertebral fractures and trabecular bone score in primary ovarian insufficiency.

PURPOSE: Bone health in primary ovarian insufficiency (POI) is under-investigated. We assessed patients with spontaneous POI for vertebral fractures (VFs) and related parameters of bone health. METHODS: 70 cases with spontaneous POI (age 32.5 ± 7.0 years) and an equal number of controls were assessed for BMD, TBS, and VFs. BMD at the lumbar-spine (L1-L4), left hip, non-dominant forearm, and TBS (iNsight software) were measured on a dual-energy X-ray absorptiometry (DXA) machine. VFs were assessed by Genant's classification. Serum FSH, LH, estradiol, T4, TSH, iPTH, serum 25(OH)D, total calcium, and inorganic phosphorus were measured. RESULTS: BMD at the lumbar-spine, hip and forearm was reduced by 11.5%, 11.4% and 9.1% in POI as compared to controls (P < 0.001). Degraded or partially degraded microarchitecture on TBS was observed in 66.7% of patients and 38.2% of controls (P = 0.001). 15.7% of the POI patients had VFs, compared to 4.3% of controls (P = 0.045). Age, duration of amenorrhea and duration of HRT use were the significant predictors of TBS (P < 0.01). Serum 25(OH)D was the significant determinant of VFs. TBS abnormalities were higher in patients with POI and VFs. BMD was not significantly different in patients with and without VFs. CONCLUSION: Thus, lumbar-spine osteoporosis, impaired TBS and VFs were present in 35.7%, 66.7% and 15.7% of patients with spontaneous POI in their early third decade. This indicates need for rigorous investigations for impaired bone health in these young patients and management with HRT, vitamin-D, and possible need for bisphosphonate therapy.

Low-dose propofol as a solo agent for sedation in postoperative ventilated liver transplant recipients: A preliminary observational study.

Background and Aims: Propofol is a commonly used sedative agent, in a dose of 1.5-4.5 mg.kg-1.h-1. Following liver transplantation (LT), drug metabolism may be altered due to liver mass, altered hepatic blood flow, reduced levels of serum proteins, and liver regeneration. Thus, we hypothesized that propofol requirements in this group of patients would be different as compared to the standard dose. This study evaluated the dose of propofol used for sedation in electively ventilated living donor liver transplantation (LDLT) recipients. Material and Methods: After patients were shifted to the postoperative intensive care unit (ICU) following LDLT surgery, propofol infusion was started at a dose of 1 mg.kg-1.h-1 and titrated to maintain a bispectral index (BIS) value of 60-80. No other sedatives such as opioids or benzodiazepines were used. Dose of propofol, noradrenaline, and arterial lactate levels were noted 2 hourly. Results: The mean propofol dose required in these patients was 1.02 ± 0.26 mg.kg-1.h-1. Noradrenaline was gradually tapered off and stopped within 14 h of shifting to ICU. The mean duration between the time of cessation of propofol infusion till extubation was 2.06 ± 1.44 h. Propofol dose did not correlate with respective lactate levels, ammonia levels, or graft-to-recipient weight ratio. Conclusion: The dose range of propofol required for postoperative sedation in LDLT recipients was lower than the conventional dose.

Determination of the optimal length of insertion for central venous catheterization via axillary vein cannulation using preoperative chest X-ray- A prospective feasibility study.

Background and Aims: Ensuring safe central venous catheter tip placement is important. Multiple techniques are available to estimate the length of catheter insertion for subclavian and internal jugular approaches. However, the methods to determine the length of insertion for the axillary route have not been validated. The purpose of this feasibility study was to evaluate a simple method for the calculation of catheter length to be inserted and assess whether it accurately predicts the correct tip placement. Material and Methods: A total of 102 patients requiring preoperative central venous cannulation were evaluated, out of which 60 had successful axillary vein (AxV) cannulation. The length of insertion was calculated using the formula: (2/3* A + B) +Y (A: Clavicular length on chest radiograph [CXR], B: Vertical distance between the sternal head and carina on CXR, Y: Perpendicular distance from the skin to the AxV on ultrasound). A postoperative CXR was used to assess the accurate tip placement (2 cm above the carina to 0.5 cm below it). The primary outcome of the study was the rate of successful placement of the central venous catheter (CVC) in terms of the correct position of the tip of the catheter when the length of the catheter inserted was predicted by the formula described previously. Results: Optimal placement was observed in 83.33% of the cases. A higher rate of accuracy was seen in the females (P value = 0.03) and shorter patients (P value = 0.01). A Bland-Altman plot depicted a high degree of agreement. Conclusion: Use of the formula using a CXR and ultrasound allowed P successful placement of the CVC tip at the desired location in 83.33% of the cases.

COVID-19 and tobacco cessation: lessons from India.

OBJECTIVES: The Government of India prohibited the sale of tobacco products during the COVID-19 lockdown to prevent the spread of the SARS-CoV-2 virus. This study assessed the tobacco cessation behaviour and its predictors among adult tobacco users during the initial COVID-19 lockdown period in India. METHODS: A cross-sectional study was conducted with 801 adult tobacco users (both smoking and smokeless tobacco) in two urban metropolitan cities of India over a 2-month period (July to August 2020). The study assessed complete tobacco cessation and quit attempts during the lockdown period. Logistic and negative binomial regression models were used to study the correlates of tobacco cessation and quit attempts, respectively. RESULTS: In total, 90 (11.3%) tobacco users reported that they had quit using tobacco after the COVID-19 lockdown period. Overall, a median of two quit attempts (interquartile range 0-6) was made by tobacco users. Participants with good knowledge on the harmful effects of tobacco use and COVID-19 were significantly more likely to quit tobacco use (odds ratio [OR] 2.2; 95% confidence interval [CI] 1.2-4.0) and reported more quit attempts (incidence risk ratio 5.7; 95% CI 2.8-11.8) compared to those with poor knowledge. Participants who had access to tobacco products were less likely to quit tobacco use compared to those who had no access (OR 0.3; 95% CI 0.2-0.5]. CONCLUSIONS: Access restrictions and correct knowledge on the harmful effects of tobacco use and COVID-19 can play an important role in creating a conducive environment for tobacco cessation among users.

F13A1 transglutaminase expression in human adipose tissue increases in acquired excess weight and associates with inflammatory status of adipocytes.

OBJECTIVE: F13A1/FXIII-A transglutaminase has been linked to adipogenesis in cells and to obesity in humans and mice, however, its role and associated molecular pathways in human acquired excess weight have not been explored. METHODS: We examined F13A1 expression and association to human weight gain in weight-discordant monozygotic twins (Heavy-Lean difference (ΔWeight, 16.8 kg ± 7.16 for n = 12). The twin pairs were examined for body composition (by dual-energy X-ray absorptiometry), abdominal body fat distribution (by magnetic resonance imaging), liver fat content (by magnetic resonance spectroscopy), circulating adipocytokines, leptin and adiponectin, as well as serum lipids. Affymetrix full transcriptome mRNA analysis was performed from adipose tissue and adipocyte-enriched fractions from subcutaneous abdominal adipose tissue biopsies. F13A1 differential expression between the heavy and lean co-twins was examined and its correlation transcriptome changes between co-twins were performed. RESULTS: F13A1 mRNA showed significant increase in adipose tissue (p < 0.0001) and an adipocyte-enriched fraction (p = 0.0012) of the heavier co-twin. F13A1 differential expression in adipose tissue (Heavy-Lean ΔF13A1) showed significant negative correlation with circulating adiponectin (p = 0.0195) and a positive correlation with ΔWeight (p = 0.034), ΔBodyFat (0.044) and ΔAdipocyte size (volume, p = 0.012;) in adipocyte-enriched fraction. A whole transcriptome-wide association study (TWAS) on ΔF13A1 vs weight-correlated ΔTranscriptome identified 182 F13A1-associated genes (r > 0.7, p = 0.05) with functions in several biological pathways including cell stress, inflammatory response, activation of cells/leukocytes, angiogenesis and extracellular matrix remodeling. F13A1 did not associate with liver fat accumulation. CONCLUSIONS: F13A1 levels in adipose tissue increase with acquired excess weight and associate with pro-inflammatory, cell stress and tissue remodeling pathways. This supports its role in expansion and inflammation of adipose tissue in obesity.

Geographical variation in case fatality rate and doubling time during the COVID-19 pandemic.

Case fatality rate (CFR) and doubling time are important characteristics of any epidemic. For coronavirus disease 2019 (COVID-19), wide variations in the CFR and doubling time have been noted among various countries. Early in the epidemic, CFR calculations involving all patients as denominator do not account for the hospitalised patients who are ill and will die in the future. Hence, we calculated cumulative CFR (cCFR) using only patients whose final clinical outcomes were known at a certain time point. We also estimated the daily average doubling time. Calculating CFR using this method leads to temporal stability in the fatality rates, the cCFR stabilises at different values for different countries. The possible reasons for this are an improved outcome rate by the end of the epidemic and a wider testing strategy. The United States, France, Turkey and China had high cCFR at the start due to low outcome rate. By 22 April, Germany, China and South Korea had a low cCFR. China and South Korea controlled the epidemic and achieved high doubling times. The doubling time in Russia did not cross 10 days during the study period.

Oral Drug Delivery Technologies-A Decade of Developments.

Advanced drug delivery technologies, in general, enable drug reformulation and administration routes, together contributing to life-cycle management and allowing the innovator to maintain the product monopoly. Over the years, there has been a steady shift from mere life-cycle management to drug repurposing-applying delivery technologies to tackle solubility and permeability issues in early stages or safety and efficacy issues in the late stages of drug discovery processes. While the drug and the disease in question primarily drive the choice of route of administration, the oral route, for its compliance and safety attributes, is the most preferred route, particularly when it comes to chronic conditions, including pain, which is not considered a disease but a symptom of a primary cause. Therefore, the attempt of this review is to take a stock of the advances in oral delivery technologies that are applicable for injectable to oral transformation, improve risk-benefit profiles of existing orals, and apply them in the early discovery program to minimize the drug attrition rates.

A comparison of measured and predicted diffusion coefficients applied to sand and silt sized acid mine drainage materials.

Determining the rate at which Acid Mine Drainage (AMD) sulfide oxidation occurs in mining waste products is a central requirement for safe and sustainable long term design of storages, including tails storage facilities, ore stockpiles and waste rock dumps. Inappropriate design can result in AMD acidification, mobilisation of heavy metals and pollution of ground and surface waters. The use of soil gas (oxygen) transport modelling to model AMD based sulfide oxidation and potential acidity loads is widespread, but diffusion coefficients used for modelling are based on existing diffusion coefficient models derived for natural and agricultural soils. Mining wastes are often well sorted due to mineral processing, and differences in soil structure and porosity can impact on diffusion coefficient behaviour compared to natural soils. This study compares a variety of approaches to estimate the diffusion coefficient and compare these results to measured values for comparison and analysis. A diffusion column apparatus is used to compare diffusion coefficient models from the literature with test results from the laboratory in several mining derived AMD materials. The results of the comparison indicate that laboratory testing of diffusion provides more accurate estimation of soil gas diffusion coefficients in mine materials. The use of diffusion coefficient safety factor approaches are explored as possible alternatives, if measurement of mine material matrix soil gas diffusion coefficient is not possible.

Challenges in comprehensive management of spinal cord injury in India and in the Asian Spinal Cord network region: findings of a survey of experts, patients and consumers.

STUDY DESIGN: Online survey. OBJECTIVES: To understand the prevailing scenario of the comprehensive management of spinal cord injuries (SCI) in India and in the Asian Spinal Cord Network (ASCoN) region, especially with a view to document the challenges faced and its impact. SETTING: Indian Spinal Injuries Centre. METHODS: A questionnaire was designed which covered various aspects of SCI management. Patients, consumers (spinal injured patients discharged since at least 1 year) and experts in SCI management from different parts of India and the ASCoN region were approached to complete the survey. RESULTS: Sixty patients, 66 consumers and 34 experts completed the survey. Difference of opinion was noticed among the three groups. Disposable Nelaton catheters were used by 57% consumers and 47% patients. For reusable catheter, 31% experts recommended processing with soap and running water and 45% recommended clean cotton cloth bag for storage. Pre-hospital care and community inclusion pose the biggest challenges in management of SCI. More than 75% of SCI faced problems of access and mobility in the community. Awareness about SCI, illiteracy and inadequate patient education are the most important factors hindering pre- and in-hospital care. Inadequate physical as well as vocational rehabilitation and financial barriers are thought to be the major factors hindering integration of spinal injured into mainstream society. Strong family support helped in rehabilitation. CONCLUSIONS: Our study brought out that SCI in India and ASCoN region face numerous challenges that affect access to almost all aspects of comprehensive management of SCI.

Telehealth for people with spinal cord injury: a narrative review.

STUDY DESIGN: Narrative review. OBJECTIVES: To find and discuss what has been published about the use of telehealth, on people with spinal cord injury (teleSCI). SETTING: International. METHOD: Cochrane Library, Ovid Medline, EMBASE and CINAHL, from 1996 till June 2017 have been searched. Searches in  PsycINFO, from 1996 till September 2017, were included afterwards. Extracted data include studies in English language, containing information about spinal cord injury and disorders, and telehealth. Literature reviews, systematic reviews, and studies containing other types of neurological disorders, were excluded. Studies were grouped based on how and to whom telehealth was offered. RESULTS: Twenty nine studies were included in the review. They were categorized according to the way teleSCI was provided, and to what modality was used. Some studies utilized more than one modality. TeleSCI seems to be favorable concerning treatment and follow-up, as well as favorable socioeconomically and environmentally. The studies spanned across several aims and outcomes. There was also heterogeneity in number of participants, the differences in modalities, and in the level of evidence. Thus  it was challenging to compare studies  and make future recommendations. CONCLUSIONS: TeleSCI can be used for examination and guiding purposes. Further research is warranted to evaluate optimal utilization, methodology and efficacy. SPONSORSHIP: The first author has received funding from the Norwegian Extra Foundation.

Probiotics, prebiotics, and microencapsulation: A review.

The development of a suitable technology for the production of probiotics is a key research for industrial production, which should take into account the viability and the stability of the organisms involved. Microbial criteria, stress tolerance during processing, and storage of the product constitute the basis for the production of probiotics. Generally, the bacteria belonging to the genera Lactobacillus and Bifidobacterium have been used as probiotics. Based on their positive qualities, probiotic bacteria are widely used in the production of food. Interest in the incorporation of the probiotic bacteria into other products apart from dairy products has been increasing and represents a great challenge. The recognition of dose delivery systems for probiotic bacteria has also resulted in research efforts aimed at developing probiotic food outside the dairy sector. Producing probiotic juices has been considered more in the recent years, due to an increased concern in personal health of consumers. This review focuses on probiotics, prebiotics, and the microencapsulation of living cells.

The reliability of measuring wound undermining in people with spinal cord injury.

OBJECTIVE: The objective of this study was to determine the reliability of measuring wound undermining in people with spinal cord injury (SCI). STUDY DESIGN: A psychometric study. SETTING: The study was conducted at the Indian Spinal Injuries Centre, New Delhi, India. PARTICIPANTS: Thirty people with a complete or incomplete SCI and a pressure ulcer with wound undermining were recruited. METHODS: Wound undermining was measured using the four cardinal points from a clock face (with 12 O'clock defined as towards the head). Inter-rater reliability was tested by comparing the wound undermining scores from two different assessors. Intra-rater reliability was tested by comparing the wound undermining scores from the same assessor on two different days. RESULTS: The intraclass correlation coefficients (95% confidence interval) for inter-rater and intra-rater reliability were 0.996 (0.992-0.999) and 0.998 (0.996-0.999), respectively. Repeat measurements by the same and different assessor were within 0.3 cm of each other, 80% and 83% of the time, respectively. CONCLUSION: Measurements of wound undermining have excellent reliability.

Cost-effectiveness analysis of telephone-based support for the management of pressure ulcers in people with spinal cord injury in India and Bangladesh.

OBJECTIVE: To determine from a societal perspective the cost-effectiveness and cost-utility of telephone-based support for management of pressure ulcers. STUDY DESIGN: Cost-effectiveness and cost-utility analysis of a randomised clinical trial. SETTING: Tertiary centre in India and Bangladesh. METHODS: An economic evaluation was conducted alongside a randomised clinical trial comparing 12 weeks of telephone-based support (intervention group) with usual care (control group). The analyses evaluated costs and health outcomes in terms of cm2 reduction of pressure ulcers size and quality-adjusted life years (QALYs) gained. All costs were in Indian Rupees (INR) and then converted to US dollars (USD). RESULTS: The mean (95% confidence interval) between-group difference for the reduction in size of pressure ulcers was 0.53 (-3.12 to 4.32) cm2, favouring the intervention group. The corresponding QALYs were 0.027 (0.004-0.051), favouring the intervention group. The mean total cost per participant in the intervention group was INR 43 781 (USD 2460) compared to INR 42 561 (USD 2391) for the control group. The per participant cost of delivering the intervention was INR 2110 (USD 119). The incremental cost-effectiveness ratio was INR 2306 (USD 130) per additional cm2 reduction in the size of the pressure ulcer and INR 44 915 (USD 2523) per QALY gained. CONCLUSION: In terms of QALYs, telephone-based support to help people manage pressure ulcers at home provides good value for money and has an 87% probability of being cost-effective, based on 3 times gross domestic product. Sensitivity analyses were performed using the overall cost data with and without productivity costs, and did not alter this conclusion.

Telephone-based management of pressure ulcers in people with spinal cord injury in low- and middle-income countries: a randomised controlled trial.

STUDY DESIGN: A multicentre, prospective, assessor-blinded, parallel randomised controlled trial. OBJECTIVES: The objective of the trial was to determine the effectiveness of telephone-based management of pressure ulcers in people with spinal cord injury (SCI) in low- and middle-income countries. METHODS: One hundred and twenty people with SCI living in the community were recruited through three hospitals in India and Bangladesh between November 2013 and March 2016. Participants had sustained an SCI >3 months prior and had a pressure ulcer. Participants were randomly allocated (1:1) to a control or intervention group. Participants in the control group received no intervention. Participants in the intervention group received weekly advice by telephone for 12 weeks about the management of their pressure ulcers from a trained health-care professional. Outcomes were measured by a blinded assessor at baseline and 12 weeks. There was one primary outcome, namely, the size of the pressure ulcer and 13 secondary outcomes. RESULTS: The mean between-group difference for the size of the pressure ulcer at 12 weeks was 2.3 cm2 (95% confidence interval -0.3 to 4.9; favouring the intervention group). Eight of the 13 secondary outcomes were statistically significant. CONCLUSION: The results of our primary outcome (that is, size of pressure ulcer) do not provide conclusive evidence that people with SCI can be supported at home to manage their pressure ulcers through regular telephone-based advice. However, the results from the secondary outcomes are sufficiently positive to provide hope that this simple intervention may provide some relief from this insidious problem in the future.

Strength training for partially paralysed muscles in people with recent spinal cord injury: a within-participant randomised controlled trial.

STUDY DESIGN: Within-participant randomised controlled trial. OBJECTIVES: To determine whether strength training combined with usual care increases strength in partially paralysed muscles of people with recent spinal cord injury (SCI) more than usual care alone. SETTINGS: SCI units in Australia and India. METHODS: Thirty people with recent SCI undergoing inpatient rehabilitation participated in this 12-week trial. One of the following muscle groups was selected as the target muscle group for each participant: the elbow flexors, elbow extensors, knee flexors or knee extensors. The target muscle on one side of the body was randomly allocated to the experimental group and the same muscle on the other side of the body was allocated to the control group. Strength training was administered to the experimental muscle but not to the control muscle. Participants were assessed at baseline and 12 weeks later. The primary outcome was maximal isometric muscle strength, and the secondary outcomes were spasticity, fatigue and participants' perception of function and strength. RESULTS: There were no dropouts, and participants received 98% of the training sessions. The mean (95% confidence interval (CI)) between-group difference for isometric strength was 4.3 Nm (1.9-6.8) with a clinically meaningful treatment effect of 2.7 Nm. The mean (95% CI) between-group difference for spasticity was 0.03/5 points (-0.25 to 0.32). CONCLUSION: Strength training increases strength in partially paralysed muscles of people with recent SCI, although it is not clear whether the size of the treatment effect is clinically meaningful. Strength training has no deleterious effects on spasticity.

Successful treatment of recalcitrant candidal intertrigo with Dr Michaels® (Fungatinex®) product family.

Candidal intertrigo is an infection of the skin caused by Candida albicans that typically occurs in opposing cutaneous or muco-cutaneous surfaces. Because Candidiasis requires a damaged and moist environment for infection, it typically occurs in areas of friction such as the skin folds of the body. Candidal intertrigo is often difficult to treat and results are often unsatisfactory. In addition, there is a lack of evidence-based literature supporting prevention and treatments for candidal intertrigo. The aim of the study was to evaluate the efficacy of Dr Michaels® (also branded as Fungatinex®) products in the treatment of fungal intertrigo, in 20 women and 2 men with a mean age of 72. Five patients (3 female and 2 male) had type 2 diabetes and 16 (14 female and 2 male) were obese. The patients were treated with Dr Michaels® (Fungatinex®) moisturising bar, topical ointment (twice daily application) and oral herbal formulation, PSC 200 two tablets twice daily with food. After 2 weeks of treatment, the lesions had mostly resolved in all patients with only slight erythema evident. After six weeks of treatment using the moisturising bar, topical ointment and oral herbal formulations from the Dr Michaels® (Fungatinex®) product family, the lesions had totally resolved in 18 patients, while 4 patients had to continue the therapeutic protocol for another 2 weeks. Our results demonstrate that the Dr Michaels® (Fungatinex®) complementary product family is efficacious in the treatment of recalcitrant candidal intertrigo. Furthermore, this study highlights that the Dr Michaels® (Fungatinex®) product family is fast-acting and well tolerated with no serious adverse events reported. These data have important implications for resistant cases of candidal intertrigo where traditional therapies have failed.

Successful treatment of mild to moderate acne vulgaris with Dr Michaels® (also branded as Zitinex®) topical products family: a clinical trial.

Acne vulgaris is an epidemic inflammatory skin disease of multi-factorial origin, frequently seen in adolescents and often persisting or occurring through to adulthood. Acne vulgaris is a nearly universal skin disease afflicting 79-95% of the adolescent population in westernized societies and is a significant cause of psychological morbidity in affected patients. Despite the various treatment options available for acne, there is still a need for a safe and effective option. The aim of the study was to investigate the efficacy and tolerability of Dr Michaels® (Zitinex®) product family in the treatment of papulo-pustular acne. 25 patients (17 female/8 male), aged 15-22, with a mild to moderate papulo-pustular acne, localized on the face and on the trunk, were included in this study. None of the patients had used any other kind of treatment in the 3 months prior to commencing this study. All of the patients were treated with Dr Michaels® (Zitinex®) facial exfoliating cleanser, activator formula, a cream, PSC 200 and PSC 900 oral supplements. Application time of Dr Michaels® (Zitinex®) products was 12 weeks. The treatment was been evaluated clinically at 0, 4, 8 and 12 weeks. All of the patients showed an improvement in all parameters of their acne (comedones, papules, pustules, hyperpigmentation and scars). The acne lesions and erythema had mostly resolved. The hyperpigmentation and pitted scarring had significantly reduced also, with the skin appearing smoother. The treatment was well tolerated and no side effects have been described. Our study demonstrates that the Dr Michaels® (Zitinex®) facial exfoliating cleanser, activator formula, cream and oral supplements PSC 200 and PSC 900 are an effective therapeutic option for the treatment of moderately severe acne vulgaris. Moreover, it highlights the safety profile of the Dr Michaels® (Zitinex®) product family in a case of acne compared to traditional first-line treatments.