A Real-World, Non-interventional Indian Study Evaluating Intensive Plant-Based Butter Moisturizing Cream in Psoriasis.

INTRODUCTION: Psoriasis is estimated to affect 0.44-2.8% of the Indian population. Moisturizers are a key adjuvant psoriasis treatment strategy, but data regarding their effectiveness, safety and compliance pattern in an Indian context are lacking. Hence, this real-world study on an intensive plant-based butter moisturizing cream (Venusia ® Max) was conducted among Indian patients with psoriasis. METHODS: This was an observational, patient-reported outcomes (PRO) study in patients with psoriasis aged 18-75 years who were prescribed the cream in routine clinical practice, as per clinician's discretion, over 4 weeks. The primary outcome measure was improvement from baseline in quality of life assessed using the Dermatology Quality of Life Index (DLQI) at 4 weeks of the study period. The secondary outcome measures were improvement in dryness using the Dry Skin/Ichthyosis Area and Severity Index (DASI) score at 4 weeks, safety and compliance. The DLQI and DASI scores were recorded by the clinicians at baseline and after 2 (optional) and 4 weeks of starting the cream. Safety was assessed throughout the study. RESULTS: The study included 400 patients from 9 outpatient dermatology centers across India. Of 400 patients, 384 completed the study. A significant reduction in both the mean DLQI score (66.7%; p < 0.001) and mean DASI score (84.6%; p < 0.001) was observed at week 4 after starting the cream vs. baseline in the overall population. Overall, the cream showed a good safety and compliance profile during the study period. There were no serious adverse events or deaths. CONCLUSIONS: The evidence from the PRO study suggests that use of the intensive plant-based butter moisturizing cream in a real-world scenario has a noticeable impact on improving the quality of life and reducing the skin dryness associated with psoriasis over 4 weeks. The moisturizing cream may serve as a valuable adjuvant treatment option for the management of psoriasis. TRIAL REGISTRATION NUMBER: CTRI/2017/03/008023. FUNDING: Dr. Reddy's Laboratories Ltd.

Real-World, Non-Interventional, Observational Study of Hydroxyzine Hydrochloride in Chronic Pruritus: a Prospective, Non-Comparative Study.

INTRODUCTION: Although hydroxyzine is widely used for symptom relief in pruritus, its clinical safety and efficacy data in the Indian setting are scarce. We conducted a study to assess the effectiveness and tolerability of hydroxyzine in the management of Indian patients with chronic pruritus in a real-world setting. METHODS: This was a prospective, observational, patient-reported outcomes (PRO) study in patients with chronic pruritus due to dermatological causes treated with hydroxyzine as per the clinician's discretion for a period of up to 12 weeks. The primary outcome was improvement in quality of life from baseline, assessed using the 10-point Dermatology Quality of Life Index (DLQI) at week 12 of the study period. Secondary outcomes were improvement in the pruritus scores (5-D itch scale) at 12 weeks, improvements in the DLQI and 5-D itch scores at 2, 4 and 8 weeks and safety. RESULTS: The study included 400 patients (179 males, 221 females) from 7 dermatology centres across India. Of the 400 patients recruited, 391 patients completed at least 2 weeks of treatment. There was significant (p < 0.0001) improvement from baseline in the DLQI scores and 5-D itch scores at 2, 4, 8 and 12 weeks; 189/391 (48.34%) patients had symptom relief leading to early termination. Overall, the treatment was well tolerated with a total of 11 mild-to-moderate adverse events reported during the study, which included dizziness, constipation, drowsiness, dry mouth and sedation. All events resolved without any intervention. There were no serious adverse events. CONCLUSION: This real-world, observational, PRO study demonstrates that hydroxyzine significantly improves symptoms of pruritus and quality of life in patients with chronic pruritus due to dermatological causes over 12 weeks. Despite the sedating potential of the drug, hydroxyzine is well tolerated in real-world settings. TRIAL REGISTRATION: CTRI/2017/06/008847. FUNDING: Dr. Reddy's Laboratories.

Accountability Studies on Air Pollution and Health: the HEI Experience.

PURPOSE OF REVIEW: Assessing health effects of air quality interventions is of ever-increasing interest. Given the prominent role Health Effects Institute (HEI) has played in accountability research, this review focuses on HEI's recent experiences, the challenges it has encountered, and provides possible directions for future research. RECENT FINDINGS: Most accountability studies to date have focused on effects of relatively short-term, local-scale, and sometimes temporary interventions. Only a few recent accountability studies have sought to investigate large-scale, multiyear regulatory programs. Common challenges encountered include lack of statistical power, how to account appropriately for background trends in air quality and health, and difficulties in direct attribution of changes in air pollution and health to a single intervention among many regulatory actions. New methods have been developed for accountability research that has shown promise addressing some of those challenges, including use of causal inference methods. These and other approaches that would enhance the attribution of changes in air quality and health directly to an intervention should continue to be further explored. In addition, integration of social and behavioral sciences in accountability research is warranted, and climate related co-benefits and dis-benefits may be considered.

Particulate matter components, sources, and health: Systematic approaches to testing effects.

UNLABELLED: Exposure to particulate matter (PM) is associated with adverse health outcomes. There has long been a question as to whether some components of the PM mixture are of greater public health concern than others so that the sources that emit the more toxic components could be controlled. In this paper, we describe the National Particle Component Toxicity (NPACT) initiative, a comprehensive research program that combined epidemiologic and toxicologic approaches to evaluate this critical question, partly relying on information from a national network of air quality monitors that provided data on speciated PM2.5 (PM with an aerodynamic diameter<2.5 µm) starting in 2000. We also consider the results of the NPACT program in the context of selected research on PM components and health in order to assess the current state of the field. Overall, the ambitious NPACT research program found associations of secondary sulfate and, to a somewhat lesser extent, traffic sources with health effects. Although this and other research has linked a variety of health effects to multiple groups of PM components and sources of PM, the collective evidence has not yet isolated factors or sources that would be closely and unequivocally more strongly related to specific health outcomes. If greater success is to be achieved in isolating the effects of pollutants from mobile and other major sources, either as individual components or as a mixture, more advanced approaches and additional measurements will be needed so that exposure at the individual or population level can be assessed more accurately. Enhanced understanding of exposure and health effects is needed before it can be concluded that regulations targeting specific sources or components of PM2.5 will protect public health more effectively than continuing to follow the current practices of targeting PM2.5 mass as a whole. IMPLICATIONS: This paper describes a comprehensive epidemiologic and toxicologic research program to evaluate whether some components and sources of PM may be more toxic than others. This question is important for regulatory agencies in setting air quality standards to protect people's health. The results show that PM from coal and oil combustion and from traffic sources was associated with adverse health outcomes, but other components and sources could not definitively be ruled out. Thus, given current knowledge, the current practice of setting air quality standards for PM mass as a whole likely remains an effective approach to protecting public health.

Evidence-based toxicology for the 21st century: opportunities and challenges.

The Evidence-based Toxicology Collaboration (EBTC) was established recently to translate evidence-based approaches from medicine and health care to toxicology in an organized and sustained effort. The EBTC held a workshop on "Evidence-based Toxicology for the 21st Century: Opportunities and Challenges" in Research Triangle Park, North Carolina, USA on January 24-25, 2012. The presentations largely reflected two EBTC priorities: to apply evidence-based methods to assessing the performance of emerging pathway-based testing methods consistent with the 2007 National Research Council report on "Toxicity Testing in the 21st Century" as well as to adopt a governance structure and work processes to move that effort forward. The workshop served to clarify evidence-based approaches and to provide food for thought on substantive and administrative activities for the EBTC. Priority activities include conducting pilot studies to demonstrate the value of evidence-based approaches to toxicology, as well as conducting educational outreach on these approaches.