IntroductionMelasma is one of the most common pigmentary disorders seen by dermatologists and often occurs among women with darker complexion (Fitzpatrick skin type IV–VI). Even though melasma is a widely recognized cause of significant cosmetic disfigurement worldwide and in India, there is a lack of systematic and clinically usable treatment algorithms and guidelines for melasma management. The present article outlines the epidemiology of melasma, reviews the various treatment options along with their mode of action, underscores the diagnostic dilemmas and quantification of illness, and weighs the evidence of currently available therapies.MethodsA panel of eminent dermatologists was created and their expert opinion was sought to address lacunae in information to arrive at a working algorithm for optimizing outcome in Indian patients. A thorough literature search from recognized medical databases preceded the panel discussions. The discussions and consensus from the panel discussions were drafted and refined as evidence-based treatment for melasma. The deployment of this algorithm is expected to act as a basis for guiding and refining therapy in the future.ResultsIt is recommended that photoprotection and modified Kligman’s formula can be used as a first-line therapy for up to 12 weeks. In most patients, maintenance therapy will be necessary with non-hydroquinone (HQ) products or fixed triple combination intermittently, twice a week or less often. Concomitant camouflage should be offered to the patient at any stage during therapy. Monthly follow-ups are recommended to assess the compliance, tolerance, and efficacy of therapy.ConclusionThe key therapy recommended is fluorinated steroid containing 2–4% HQ-based triple combination for first line, with additional selective peels if required in second line. Lasers are a last resort.Electronic supplementary materialThe online version of this article (doi:10.1007/s13555-014-0064-z) contains supplementary material, which is available to authorized users.

A significant population of India suffers from chronic pain, and their QoL is affected leading to disability. A proportion of respondents receiving pain treatment were taking nonprescription medications with a majority of respondents on NSAIDs. A very few were consulting pain management specialists.

BackgroundMelasma is one of the most common pigment disorders seen by a dermatologist and often occurs among women with darker complexion (skin type IV–VI).AimsThe present study aimed to investigate the epidemiology of melasma in the Indian population and to focus on the regional variability in the demographics, clinical manifestations and factors that precipitate this condition.MethodsThe present multicentric study conducted across four regions in India enrolled patients (>18 years) diagnosed with melasma on Wood’s light examination. Patients were examined to identify the distribution of melasma. Various precipitating and etiological factors for melasma were documented.ResultsThe mean age of the 331 enrolled patients with melasma was 37.2 ± 9.3 years. The prevalence of melasma was higher in females with a female to male ratio of approximately 4:1. The overall population with family history was 31%, highest in the northern region (38.5%) and lowest in the eastern region (18.2%). The two prominent patterns of distribution were centrofacial (42%) and malar (39%). Only 35% of the patients were using sunscreens. Of these, 10% of the patients used sunscreen with SPF >50. The usage of sunscreens was observed to be highest in the north (69%). About 51% of women with multiple pregnancies had a history of melasma when compared with single women (25%) or with no pregnancy (24%).ConclusionsIn conclusion, the result of the study showed that there was a regional variability in the demographics, clinical manifestations and factors that precipitate melasma among patients in India. There was a strong correlation between the family history and prevalence of melasma. Sun exposure is a major precipitating factor in melasma, but only 10% of the patients used sunscreen with SPF >50. Other factors such as concomitant medication, chronicity of disease, multiple pregnancies and use of oral contraceptives might precipitate melasma.Electronic supplementary materialThe online version of this article (doi:10.1007/s13555-014-0046-1) contains supplementary material, which is available to authorized users.

Changing epidemiology of Hepatitis A virus (HAV) has led to an increased susceptibility of adolescents and adults to the infection. Vaccination can remarkably reduce the incidence and associated morbidity of HAV infection. This review is focused on the safety and efficacy of H2 strain derived live attenuated Hepatitis A vaccine. We found the vaccine to be highly immunogenic with minimal or negligible safety issues. Moreover, a single dose of live attenuated vaccine persists a long term immune response and can be a preferred option for developing countries. In 2014, Indian Academy of Paediatrics (IAP) also updated their recommendations for H2 vaccine as a single dose as against the previous 2 dose schedule. A focused approach to include the vaccine in national immunization program should be explored.

Clinical trials provide a foundation for new drug development processes, as well as for product license extensions for existing therapies. The reduction in the amount of time and cost to conduct a clinical trial becomes important, as competition to bring a new drug to the market is increasing, and so is the search for new markets. Kenya, Nigeria, Tanzania, Uganda, and Zambia offer a diverse patient population, as well as a comparatively research-friendly and ambitious government to develop these countries as pharmaceutical and health sectors of excellence. All these countries have their own guidelines to conduct clinical trials that feature some similarities and some subtle differences. Over the last decade, the guidelines have been evolving to provide a good ground to foreign sponsors, which carry out clinical trials while keeping the interest of patients as a priority. In the advent of these evolving guidelines, it becomes important for a foreign sponsor to understand and be aware of these guidelines before carrying out clinical trials. The present paper attempts to collect and compile all information available regarding the guidelines on the conduct of trials by a foreign sponsor in these five countries, which are available at government websites and search engines. The information gathered was organized into simplified flowcharts for easy understanding and usage. A clear understanding of the guidelines can effectively reduce the challenges faced for conducting clinical trials in these countries.

BackgroundNon-steroidal anti-inflammatory drugs (NSAIDs) are the most common therapeutic products used for the management of inflammation and pain. However, their use is associated with gastrointestinal (GI), cardiovascular and renal complications. Although prevalence data regarding NSAID-induced complications are available worldwide, but none of the study has assessed the prevalence of GI, cardiac and renal complications in India. This study aimed to assess the point prevalence of GI, cardiac and renal complications associated with the use of NSAIDs in India. The study also aimed to evaluate the association between the risk factors and GI, renal and cardiac complications in patients using NSAIDs.MethodsThis prospective, cross-sectional, multi-centric study was conducted in eight medical colleges across India (North, East, West, South and Central India). Data related to GI complications including gastric, duodenal and gastroduodenal erosions/ulcers/gastritis, renal complications including acute and chronic renal failure or cardiac complications including acute coronary syndrome (ACS), acute myocardial infarction (AMI) and cardiac failure, were collected from patients.ResultsThe cut-off date for interim data analysis was July 7, 2014. A total of 2,140 patients out of 3,600 were enrolled from eight centers at the time of interim analysis. The NSAID-associated point prevalence of GI complications was 30.08%; cardiac complication was 42.77%; and renal complication was 27.88%.ConclusionsResults of the present interim analysis show that the prevalence of GI, cardiac and renal complications among patients is high due to exaggerated usage; however, the final analysis would provide the overall prevalence of these complications.

IntroductionSkin and soft tissue infections involve microbial invasion of the skin and underlying soft tissues and are estimated to affect 7–10% of hospitalized patients worldwide. Nadifloxacin, a topical fluoroquinolone, has been shown to be effective against aerobic Gram-negative, Gram-positive (including MRSA and coagulase-negative staphylococci), and anaerobic bacteria. However, there is paucity of data comparing efficacy and safety of 1% nadifloxacin with other anti-bacterials for skin infections in Indian patients.MethodsThis article presents the results of one post-marketing surveillance (PMS) and three randomized, open, non-blinded, multi-centric clinical studies that compared nadifloxacin with mupirocin and framycetin, and nadifloxacin with fusidic acid. Patients in India, aged from 1 to 65 years old, suffering from mild to moderate bacterial skin infections including impetigo, secondarily infected wounds, folliculitis, infected atopic dermatitis, and furunculosis were randomly allocated to three treatment groups within the studies. Efficacy was assessed by the evaluation of symptoms of erythema, exudation, swelling, pruritus, crusting, pain and tenderness in all the studies.ResultsA total of 272 subjects were enrolled in the study and subjects were randomly assigned to one of the three treatment groups; 92 in the nadifloxacin group, 90 in the mupirocin group, and 90 in the framycetin group. A significant reduction in the mean scores for bacterial infection symptoms in the nadifloxacin groups was observed when compared to mupirocin, framycetin and fusidic acid groups. Both physician and patients rated nadifloxacin as excellent (complete remission of symptoms) on a 4-point scale in the studies. No adverse events (AEs) were reported in the clinical studies. In the PMS, only two patients (of 329, 0.6%) reported AEs including burning and itching, one in each patient that had resolved at the time of reporting.ConclusionNadifloxacin, a fluoroquinolone, is a new alternative topical agent in the treatment of bacterial skin infection with minimal AEs.Electronic supplementary materialThe online version of this article (doi:10.1007/s13555-014-0062-1) contains supplementary material, which is available to authorized users.

IntroductionScar formation is a natural part of the healing process that occurs when the skin repairs wounds caused by burns, trauma, surgery or disease. The appearance of scars often leads to adverse psychological effects, loss of self-esteem and the associated stigmatism and diminished quality of life. Silicones are emerging as the standard treatment for prevention of a wide range of scars. The present study evaluated the safety and efficacy of an advanced formula topical silicone gel for prevention of post-operative hypertrophic and keloid scars.MethodsAn open-label prospective trial was conducted. Patients who had undergone prior surgery (10 days–3 weeks) and having recent post-surgical scars were enrolled. Patients were asked to apply the gel twice daily to the affected areas for 3 months. Pigmentation, vascularity, pliability, height of scar and pain and pruritus in the scar were assessed. Photographs of scars were taken before commencement of treatment and at follow-up visits.ResultsA total of 36 patients were enrolled. At baseline, height of the scar was 2–5 mm in 57.6 % (19/33) of the subjects which was reduced in subsequent visits (P < 0.05). Hyperpigmentation (score 3) was present in 91% (30/33) of patients at baseline and was reduced to normal (score 0) after 2 months of treatment in 40% (6/14) of patients (P = 0.0313). Vascularity (54.6%, 18/33) at baseline was also reduced over the 3 months period (P = 0.0313) A significant decrease (30%, 3/10) (P = 0.0313) in pliability was seen after 3 months of treatment from the baseline (57.6%, 19/33). Only two patients reported pruritus and pain at the baseline visit; one patient reported improvement after treatment. Itching was reported as an adverse drug reaction in two patients.ConclusionThese preliminary findings suggest that advanced formula silicone gel is safe and effective in the prevention of hypertrophic and keloid scars; however, larger, controlled studies are warranted.Electronic supplementary materialThe online version of this article (doi:10.1007/s13555-013-0036-8) contains supplementary material, which is available to authorized users.