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Background: Filaggrin (FLG) gene encoding the protein filaggrin plays an important role in barrier function of the skin and its alteration is a predisposing factor for atopic dermatitis. FLG gene variants result in absent or decreased filaggrin protein. Worldwide, the prevalence of FLG variants ranges from 14 to 56%. FLG null variants are distinct in each population. Objectives: To study the FLG gene polymorphisms in Indian children and attempt a genotype-phenotype correlation in atopic dermatitis. Methods: This was a cross-sectional, multicentre study conducted on 75 Indian children. Demographic details, clinical features and identified FLG null variants were recorded. We performed a whole gene sequencing of the entire FLG coding region using next-generation sequencing technology. Results: The prevalence of FLG null variants was 34.7%. A total of 20 different FLG loss of function variants in 26 children were documented. Sixteen (80%) variants were novel and four (20%) were previously reported in Asian and European populations. We found a statistically significant association between FLG variants with early age of onset of atopic dermatitis (P = 0.016) and elevated serum IgE levels (P = 0.051). There was no significant difference between atopic dermatitis phenotypes in children having one variant as compared to children harbouring two or more null variants. Limitations: Small sample size. Conclusion: Our study reports a unique set of FLG variants different from Asian and European populations, with these variants being significantly associated with an early age of onset of atopic dermatitis and elevated serum IgE levels. [ABSTRACT FROM AUTHOR]

This article discusses the importance of registering an ethics committee before conducting biomedical research in India. The article explains that ethics committee approval is mandatory and that committees must be registered with the Central Drugs Standard Control Organization (CDSCO) or the Department of Health Research (DHR) depending on the type of research. The article provides detailed instructions on how to register an ethics committee on the DHR and CDSCO portals, including the necessary documents and steps. The registration remains valid for a certain period of time and must be renewed if there are any changes. Overall, registering the ethics committee ensures the quality and ethical supervision of clinical trials and biomedical research. [Extracted from the article]

Background: Impact of COVID-19 pandemic has been immense. An innocent casualty of this disaster is medical education and training. Dermatology, which primarily deals with out-patient services, medical and surgical interventions, and in-patient services, was one of the worst hit. The National Medical Commission of India has implemented competency-based medical education (CBME) in Dermatology, Venereology, and Leprosy since 2019. The new curriculum relies on acquiring practical and procedural skills, training skills in research methodology, professionalism, attitude, and communication. Objectives: The study was undertaken to understand the implications of the COVID-19 pandemic on postgraduate dermatology CBME training in India. Materials and Methods: A questionnaire-based survey was carried out on postgraduate dermatology teachers and residents in India after obtaining ethics committee approval. An online semi-structured English questionnaire was administered by Google Forms. The calculated sample size was 366 dermatology faculty and 341 postgraduate students. Validity (Content validity ratio (CVR) ≥0.56) and reliability (Cronbach's alpha coefficient 0.7249) of the questionnaire were determined. Results: Among the 764 responses received, 51.4% reported that their institutes were converted to exclusive COVID hospitals. Domains of dermatology education affected were procedural training (n = 655), bedside clinical teaching (n = 613), outpatient department-based clinical teaching (n = 487), bedside laboratory procedures (n = 463), research activities (n = 453), histopathology (n = 412), and theory classes (n = 302). To keep up with the teaching-learning process, online platforms were mostly utilized: Zoom Meeting (n = 379), Google Meet (n = 287), and WhatsApp Interaction (n = 224). Teaching during ward rounds was significantly more affected in exclusively COVID institutes than non-exclusive COVID institutes (P < 0.001). Psychomotor skill development suffered a major jolt with 26.7% of respondents reporting a standstill (P < 0.001). Communication skills among students suffered due to social distancing, mask, and poor attendance of patients. According to 23.84% of respondents, formative assessment was discontinued. Conclusion: Online seminars, journal clubs, and assessments have been incorporated during the pandemic. Online modalities should be used as a supplementary method as psychomotor skills, communication skills, research work, and bedside clinics may not be replaced by the e-learning. [ABSTRACT FROM AUTHOR]

Introduction: As Oral Lichenplanus (OLP) is considered a T cell mediated disease associated with a Th1 imbalance of cytokine production, most of the therapeutic interventions have aimed to target the inflammatory pathway underlying OLP. The most commonly used anti-inflammatory medication is corticosteroids. Although, the JAK-STAT pathway inhibitor drug Tofacitinib has been postulated to be useful in the management of Lichen Planus. Aim: To assess the Lichen Planus Activity and Damage Index (LiPADI) and to assess the quality of life of the patients through Oral Health Impact Profile-14 (OHIP 14) and Dermatology Life Quality Index (DLQI). Materials and Methods: This was an institution based, investigatorblind randomized controlled trial conducted after obtaining clearance from ethics committee and registering in the clinical trial registry (CTRI/2023/07/055368). Patients were screened into either Group A (Receiving oral prednisolone 0.5 mg/kg/day) or Group B (Receiving Tofacitinib 5 mg twice/day) with allocation ratio 1:1 as per the randomization sequence. Participants from both the groups had their oral and dermal health related quality of life evaluated using a questionnaire. (OHIP-14 questionnaire and DLQI). Physician blinding was achieved by Sequentially Numbered Opaque Sealed Envelope (SNOSE) technique. Informed consents, blood, Lipid and Urea profile, Chest x rays were obtained. Follow up visits were conducted in 2 weeks, 6 weeks, 12 weeks and their effectiveness parameters, side effects, severity index of the disease, quality of life were monitored. Results: Both the groups were comparable at baseline with regards to number of lesions and its severity. Oral and Dermal lesions improved significantly from 1st follow-up (2nd week) onward in both the groups. OHIP-14 and DLQI was also noted to be improved at 12th week in both the groups. Conclusion: Tofacitinib significantly improves the cure rate in Lichen Planus with lesser number of side effects as compared to Prednisolone. Though 6 weeks of treatment is not sufficient to achieve complete cure. [ABSTRACT FROM AUTHOR]

Introduction: Vitiligo is a multifactorial disorder, most often explained by the autoimmune hypothesis. The objective of this study is to measure the levels of cytokines IL-6, TNF-α, and IFN-γ in the blood and skin (lesional and uninvolved) of vitiligo patients and to compare it with that of age-matched controls. Methods: IL-6, TNF-alpha, and IFN-gamma cytokines were measured with a BioRad 6110 ELISA reader. We compared the levels of these cytokines in generalized versus localized vitiligo and stable versus unstable vitiligo. We also correlated cytokine levels in blood/lesion/uninvolved skin with body surface area (BSA) involvement and Vitiligo Disease Activity (VIDA) scoring. Result: Forty-three participants, each with vitiligo and control, were analyzed. The values of TNF-α and IL 6 in sera were significantly higher in the vitiligo group compared with the controls (p < 0.001), whereas INF-γ was significantly lower in the vitiligo group than the control group. TNF-α, INF-γ levels when compared between blood, lesional skin, and normal skin in all vitiligo patients were found to be significant (p < 0.001). Conclusion: We conclude vitiligo is strongly associated with increased levels of TNF-α and IL 6. [ABSTRACT FROM AUTHOR]

Introduction: Pyogenic granulomas are benign vascular lesions of the skin and mucosa which are often a source of concern because of their recurrent bleeding even with minimal trauma. Current treatment for pyogenic granuloma is ablative; no medical therapy is standardized to date. Timolol, due to its vasoconstrictive effect, vascular growth factor inhibition and apoptosis promotion properties, is a potential therapeutic option. Objectives: To assess the effectiveness and safety of topical timolol in the treatment of pyogenic granulomas. Methods: A two-centre, double-blind and placebo-controlled trial (Registration CTRI/2019/04/018581) was conducted. Patients of either sex were recruited with pyogenic granuloma lesions of less than eight weeks duration. Topical treatment with 0.5% timolol or matching glycerin placebo was continued for six weeks. Changes in color, size, bleeding tendency, physicians’ and patients’ global assessments and adverse events were assessed. Results: Forty subjects were randomized between the two groups which were comparable in age, sex, duration of illness and baseline lesion size. Significant improvement was noted with timolol, with color change from first follow-up onwards and lesion size reduction from second follow-up onward. Patients’ assessment of bleeding tendency also showed imrovement from the second visit onward. Between-group comparison showed significant difference with respect to percentage reduction in size (timolol 40.9%, placebo 3.4%; P = 0.002). Rescue treatment (electrosurgery) was required in five patients on placebo and in one in the timolol group (P = 0.182). Complete resolution occurred in 2 (10%) patients with timolol and in no patients on placebo (P = 0.231). Limitations: We observed effects of treatment for only six weeks. Conclusion: Topical timolol may be a treatment option for early pyogenic granulomas but complete resolution is unlikely in six weeks. Studies of longer duration are required to assess resolution and recurrence rates. [ABSTRACT FROM AUTHOR]

Introduction: Chronic urticaria is common and distressing dermatosis where the search for newer agents with improved effectiveness and tolerability profile is a felt need. Bepotastine, a second-generation antihistamine, with added effect on suppression of eosinophil migration has a prospect in the management of chronic urticaria. Aims: To assess and compare effectiveness and safety of bepotastine versus levocetirizine in chronic urticaria. Materials and Methods: Single-center, investigator-blind, randomized, active-controlled, parallel-group phase IV trial (CTRI REF/2018/04/019692) conducted on adult patients of chronic urticaria of either sex. Patients were randomized into receiving either bepotastine besilate 10 mg tablet twice daily or levocetirizine 5 mg tablet once daily with fortnightly follow-up for 6 follow-up visits after thebaseline evaluation. The primary outcome measures were Urticaria Activity Score 7 (UAS7) and Urticaria Total Severity Score (TSS). Routine hematological, biochemical tests, treatment-emergent adverse events were monitored for safety. Results: Thirty patients in the bepotastine group and 29 patients in the levocetirizine group were analyzed by modified-intention-to-treat criteria. The study groups were comparable at the baseline with respect to the severity of chronic urticaria. UAS7 and TSS reduced significantly (P < 0.001, Friedman's ANOVA) in both treatment groups from 1st follow-up visit and 2nd follow-up visits (P < 0.05, Post Hoc Dunn's test) At the test-of-cure visit, UAS7 (5.13 ± 8.21 vs 7.48 ± 8.96) and TSS (5.10 ± 4.06 vs 7.07 ± 4.48) were less with bepotastine than levocetirizine although not statistically significant (P = 0.188 and 0.073, respectively, Mann–Whitney U test). Sedation during daytime was found to be significantly more (P < 0.001, Fischer's exact test) with levocetirizine than bepotastine (73.3% vs 17.2%). Conclusion: Bepotastine is comparable to levocetirizine with respect to its effectiveness with an edge in terms of side-effect (sedation during day time); thus, it offers a new therapeutic option in chronic urticaria. [ABSTRACT FROM AUTHOR]

Well‑designed and rigorously conducted randomized controlled trial (RCT) can produce most valid and precise scientific evidence. Any intervention, be it systemic or topical medicine, dermatology procedure needs to be tested for its efficacy in improving particular disease condition and RCT should come into mind of investigator. The biggest strength of RCT lies in two self‑explanatory factors; they are randomized and controlled. Randomization of study subjects eliminates selection and confounding bias and controlling of study condition improves the internal and external validity of findings. “Blinding” eliminates assessment bias. If one starts a comparative study without stating proper hypothesis, he/she would end up collecting lots of data which does not make sense. PICOT format helps in formulating research question. Writing a detailed protocol based on hypothesis describing in detail methodology, sample size calculation, randomization method, and blinding procedure up to statistical analysis plan is very important step in planning of RCT. Trials registered prospectively contribute to transparency of the trial and are considered to reduce the publication bias by reducing selective publication of positive outcomes. Adverse events can occur at any time during conduct of an RCT and should be reported and kept track of. Physical injury resulting from clinical trial participation is entitled to financial compensation. During preparation of final manuscript of study, the CONSORT guidelines must be followed to improve the quality of reporting of RCTs. Clinical trials provide evidence‑based approach in medicine and a designed and well‑implemented trial can alter clinical dermatology practice for a healthier tomorrow. [ABSTRACT FROM AUTHOR]

Background: Immunotherapy for wart employs ability of immune system to recognize certain viral, bacterial, and fungal antigens in previously sensitized individual inducing Type IV delayed-type hypersensitivity reaction (up-regulated Th1 cytokines IL-1, TNF-α, IFN-γ; down-regulated Th2 cytokines IL-10), not only to injected antigen but also against wart virus. Aims: To evaluate and compare the pattern of production of Th1 cytokines (IL-1, TNF-α, IFN-γ) and Th2 cytokines (IL-10) in patients receiving immunotherapy with purified-protein-derivative (PPD), Mycobacterium w (Mw), or mumps-measles-rubella (MMR) vaccine. Methods: The cohort study conducted on patients receiving immunotherapy with PPD, Mw, or MMR which was injected intradermally at baseline, repeated every 2 weeks for 6 doses?. Five-millilit?e?r blood was collected for evaluation of cytokines at baseline and 12 weeks of treatment. Blood was centrifuged to separate serum, stored at -80°C. Cytokines were measured by ELISA using a standard kit. Results: Nine participants in PPD group, 11 in Mw group, and 12 in MMR group completed the study. IL-1 was raised from baseline in all study arms and was significant in PPD group (P = 0.008). There was a predicted increase in IFN-γ in Mw and MMR groups but not in the PPD group. In the PPD group, IFN-γ was found to be down regulated. IL-10, a Th 2 cytokine was down regulated in all the groups at the study end from baseline, significantly so in the PPD group (P = 0.027) and MMR group (P = 0.001). TNF-α, being a Th1 cytokine was down regulated in all groups instead of an increase. In PPD group, IL-10 was significantly low at study end in patients who had complete resolution of warts. Limitations: Longer follow-up could not be done due to logistic issues. Conclusion: IL-1, TNF-α upregulation and IL-10 downregulation confirm that cytokine milieu plays an important role in wart immunotherapy. TNF-α has no contributory role. IL-10 can be used as a biomarker of complete response in PPD therapy. [ABSTRACT FROM AUTHOR]

Post-kala-azar dermal Leishmaniasis (PKDL) is one of the important neglected tropical diseases, which has a tremendous epidemiological significance, being the reservoir of kala-azar. Relapse and resistance to treatment along with the lack of a drug of choice and consensus treatment guideline pose a significant problem in the management of PKDL. The aim of this article was to review the available therapeutic options for PKDL, with special emphasis on their pharmaco-dynamics, pharmaco-kinetics, effectiveness, safety, tolerability, and cost factor. A comprehensive English language literature search was done for therapeutic options in PKDL across multiple databases (PubMed, EMBASE, MEDLINE, and Cochrane) for keywords (alone and in combination). MeSH as well as non-MeSH terms such as "Kala-azar," "Leishmaniasis" AND "Treatment," "Management," "Antimony Sodium Gluconate," "Meglumine Antimoniate," "Amphotericin B," "Paromomycin," "Miltefosine" were taken into consideration. Among 576 relevant articles, 15 were deemed relevant to this review. These articles were evaluated using "Oxford Centre for Evidence-Based Medicine (OCEBM)" AND "strength of recommendation taxonomy" (SORT) with respect to the level of evidence and grade of recommendation. The review includes 15 studies. The use of sodium stibogluconate is being discouraged because of multiple documented reports of treatment failure. Liposomal amphotericin B is emerging as a favorable option, owing to its superiority in terms of effectiveness and safety profile. Miltesfosine is the drug of choice in India because of the ease of oral administration and minimal risk of toxicity. Isolated Paromomycin alone is not effective in PKDL; however, combination therapy with sodium stibogluconate is found to be safe and effective. Combination of amphotericin B and miltefosine is one of the excellent options. Immunotherapy with combination of alum-precipitated autoclaved Leishmania major (Alum/ALM) vaccine + Bacille Calmette-Gu´erin (BCG) has shown promising results. Kala-azar continues to haunt the tropical countries and PKDL being its reservoir is threatening its elimination. With the availability of drugs such as liposomal amphotericin B and miltefosine, apart from the advent of immunotherapy, the future of treatment of this condition looks promising. [ABSTRACT FROM AUTHOR]

Background: Autologous serum therapy aims to supplement the existing pharmacotherapy in chronic urticaria by decreasing the antihistamine pill-burden and maintaining symptom-free interval. Subcutaneous autologous serum therapy further modifies the amount of serum (2 mL to 1 mL) and gauge of a needle (24G to 31G) to improve compliance and facilitate ease of application.Objectives: To assess clinical effectiveness and safety of subcutaneous autologous serum therapy versus conventional intramuscular autologous serum therapy and to compare the quality of life in the two treatment arms.Methods: Institution-based, assessor-blind, prospective, randomized, parallel-group, active-controlled trial with 32 patients in each treatment arm and analyzed on a modified intention to treat principle. After baseline autologous serum skin test, autologous serum was injected as per randomization every week for 9 consecutive weeks.Results: Among the study population, conventional intramuscular autologous serum therapy and subcutaneous autologous serum therapy had a comparable duration of disease (P = 0.164, Mann-Whitney U test), autoreactive status (P = 0.796), urticaria total severity score (P = 0.637) and urticaria activity score summed up over 7 days (P = 0.982). Both urticaria activity score summed up over 7 days and total severity score along with antihistamine pill-burden reduced significantly (P < 0.001, Friedman's analysis of variance) in both subcutaneous autologous serum therapy and conventional intramuscular autologous serum therapy from first follow-up onwards (P < 0.05, Post hoc Dunn's test). Significant improvement was noted in patient's as well as physician's global assessment of disease activity improvement scale (P < 0.001, Friedman's analysis of variance). Intergroup analysis showed that there was no significant difference in urticaria activity score summed up over 7 days either at baseline (P = 0.982, Mann-Whitney U test) or at study end (P = 0.398, Mann-Whitney U test). Similar comparable results were found in the total severity score at the end of the study (P = 0.345, Mann-Whitney U test). Dermatology life quality index showed marked improvement with both types of treatment (P < 0.0001, Wilcoxon test), and the intergroup comparison showed comparable dermatology life quality index values (P = 0.994, Mann-Whitney U test). The pain score at the injection site was more with conventional intramuscular autologous serum therapy than subcutaneous autologous serum therapy (P = 0.0115, Mann-Whitney test). Younger age and lower baseline total severity scores were associated with a better therapeutic response. Baseline urticaria activity score added up over a period of 7 days and total severity scores and the diameter of lesions showed a positive correlation with response pattern.Limitation: Basophil histamine release assay not done. Logistics could not support follow-up beyond the end of treatment.Conclusion: Subcutaneous autologous serum therapy is not inferior to conventional intramuscular autologous serum therapy with the additional advantage of less pain and operational feasibility. [ABSTRACT FROM AUTHOR]

An editorial is presented on the Bio‑Medical research in COVID‑19 times, which is public health emergency has impacted not only the life of the people worldwide but also biomedical and health research in unprecedented ways. It mentions that the research can be focused on COVID‑19 but understanding the fact that every researcher has their own niche and interest and not everyone would be inclined to COVID‑19.

Background: Trophic ulcers secondary to leprosy pose a great stigma to patients and remain a challenge to the treating dermatologists. Platelet-rich plasma (PRP) introduces growth factors directly into the wound and aids in rapid healing. The role of PRP in the treatment of trophic ulcers in leprosy patients has not yet been established by randomized controlled trials.Aims: To study the effectiveness and safety of autologous PRP therapy with total contact casting versus total contact casting alone in the treatment of trophic ulcers in leprosy.Methods: In an observer-blind, randomized (1:1) controlled study, 118 patients were enrolled. PRP was prepared by the manual double-spin method (1600 rpm for 10 min followed by 4000 rpm for 10 min). After wound bed preparation, activated PRP was injected intra- and perilesionally, and platelet-poor plasma gel was applied over the ulcer bed. Occlusive dressings and total contact casting were then applied in Group A, and only total contact casting was applied in Group B. The same procedure was repeated every 2 weeks for 8 weeks.Results: In all, 56 patients were analyzable in Group A and 52 in Group B. The surface area of the ulcer decreased significantly from first follow-up onward in both the groups (P < 0.001 in both the groups). Intergroup comparison showed that the reduction in the surface area of the ulcer was significantly more in Group A than in Group B from the first follow-up onward (P = 0.038) and the difference was maintained till the fifth follow-up (P < 0.001). At the end of the study, 91.10 ± 9.65% ulcer surface area reduction had occurred in Group A, whereas it was 79.77 ± 17.91% in Group B (P < 0.001). Trophic ulcers healed completely more often in paucibacillary leprosy patients (P < 0.001) and in those with a lower initial surface area of the ulcer (P < 0.001).Limitation: Short duration of treatment (8 weeks).Conclusion: PRP combined with total contact casting accelerates the healing of trophic ulcers of leprosy and is more effective than total contact casting alone. Complete remission is more likely to occur when the duration and surface area of ulcer are less and in the paucibacillary spectrum. [ABSTRACT FROM AUTHOR]

Introduction. We undertook a prospective, interventional study to evaluate the efficacy and safety profile of Intense Pulsed light (IPL) treatment of melasma in dark skin phenotypes. Material and Methods. The study was conducted in 32 patients of skin type IV and V. IPL with 640 nm and 690 nm filters was used. The patients were called once a month to undergo 6 sessions. Melasma area and severity index (MASI) and Clinician Global Impression Scores were used for evaluation. We followed "per protocol" analysis. Results. Out of 26 patients who completed the treatment, 12 patients showed improvement, MASI remained unchanged in 10 patients and 4 patients showed deterioration. MASI scores before and after treatment were 6.70 ± 3.53 and 6.32 ± 3.90 (p value=0.6891). Erythema and pain were the common side effects noted. Seventeen out of 32 patients had thyroid disorders. Conclusion. IPL should be avoided as a first line therapy in darker skin type. However, it can be used as an adjuvant therapy in some cases after careful deliberations. [ABSTRACT FROM AUTHOR]

Background: Leprosy is a chronic infectious disease caused by Mycobacterium leprae affecting the skin, peripheral nervous system, and other tissues. The disease is associated with social stigma, and the patients sometimes suffer social discrimination because it often leads to visible physical deformities. Hence, leprosy may have severe impact on the quality of life (QoL) of patients. Aims and Objectives: The aim of this study was to assess the effect of leprosy on the QoL of the affected patients and to find out whether there is some association with certain demographic and clinical factors. Materials and Methods: The Dermatology Life Quality Index (DLQI) questionnaire was used to assess the QoL of 114 patients with leprosy who attended dermatology outpatient department of a tertiary care center of eastern India. This was a cross-sectional study. Results: Among a total of 114 patients, leprosy had no impact on the QoL of 15 (13.16%) patients. There was a mild impact in 23 (20.18%) of the patients. There was moderate impact in 37 (32.46%) of the patients. The disease had severe impact in the QoL of 39 (34.21%) patients. None of the patients had a very severe impact. Several of the clinical aspects such as nerve involvement, systemic features, deformity, disability grade, and type of leprosy have significant impact on QoL. Among the demographic factors, gender had some effects on QoL. Conclusion: Leprosy adversely affects the QoL of those affected. Although it is considered a social disease, at least in our part of the country, demographics have minimal effect on the QoL. Rather, important clinical aspects such as systemic features, nerve involvement, reaction, deformity, and disability have profound impact on the QoL of the patients. [ABSTRACT FROM AUTHOR]

Biomedical research relies on proving (or disproving) a research hypothesis, and P value becomes a cornerstone of "null hypothesis significance testing." P value is the maximum probability of getting the observed outcome by chance. For a statistical test to achieve significance, the error by chance must be less than 5%. The pros are the P value that gives the strength of evidence against the null hypothesis. We can reject a null hypothesis depending on a small P value. However, the value of P is a function of sample size. When the sample size is large, the P value is destined to be small or "significant." P value is condemned by one school of thought who claims that focusing more on P value undermines the generalizability and reproducibility of research. For such a situation, presently, the scientific world is inclined in knowing the effect size, confidence interval, and the descriptive statistics; thus, researchers need to highlight them along with the P value. In spite of all the criticism, it needs to be understood that P value carries paramount importance in "precise" understanding of the estimation of the difference calculated by "null hypothesis significance testing." Choosing the correct test for assessing the significance of the difference is profoundly important. The choice can be arrived by asking oneself three questions, namely, the type of data, whether the data is paired or not, and on the number of study groups (two or more). It is worth mentioning that association between variables, agreement between assessments, time-trend cannot be arrived by calculating the P value alone but needs to highlight the correlation and regression coefficients, odds ratio, relative risk, etc. [ABSTRACT FROM AUTHOR]

Background and Aims: Irritable bowel syndrome (IBS) is a chronic relapsing disorder characterized by abdominal pain-discomfort and altered bowel habits. The IBS-diarrhoea predominant subtype (IBS-D) is defined as >25% of bowel movements representing type 6 or 7 of the Bristol Stool Form Scale. Management of IBS-D is mainly symptomatic, including lifestyle modification. Due to absence of standard treatment, multiple drugs are used. A controlled release (CR) form of mebeverine, recommended for spasmodic gastrointestinal disorders (including IBS) has recently been introduced in Indian market. We have conducted a placebo-controlled double blind randomized controlled trial [CTRI/2018/03/012897] to evaluate the effectiveness and safety of this product. Methods: 40 patients of IBS-D were recruited from medicine out-patient department (OPD) of a tertiary care hospital and randomized to two parallel groups. One received mebeverine 200 mg CR tablets twice daily for 8 weeks, while other received matching placebo. Outcome parameters were number of bowel movements per day over past 7 days (NoBM7d), severity of abdominal cramps and IBS quality of life (IBSQoL) score. Medication adherence record and treatment emergent adverse events were captured. Results: Mebeverine group showed modest but statistically significant improvement in NoBM7d, cramps and IBSQoL from baseline to 4 and 8 weeks. The changes within the placebo group were not statistically significant. Also, the intergroup differences at both 4 and 8 weeks were not statistically significant. Adherence was better in mebeverine group and both interventions were well tolerated. Conclusions: Mebeverine 200 mg CR twice daily has modest effect in IBS-D and therefore will not be a good choice for patients with severe symptoms. [ABSTRACT FROM AUTHOR]

Clinical trials looking at which treatment is better must have certain checks in place. Appropriate "control" selection while comparing the investigating agent to the "control group is essential to rule out selection bias. Randomization is another step to minimize variability or "confounders." By randomization, research participants have an equal chance of being selected into any treatment group of the study, generating comparable intervention groups, thereby distributing the confounders. A trial can be "open labeled" or "blinded." By the process of blinding, we make the participant and/or assessing physician unaware of the treatment he/she is going to receive. Thus, the element of bias which can creep in owing to personal preference or subjective component to the assessment of outcome can be eliminated. Concealment of allocation is done as the participant enters the trial. Concealment secures randomization and prevents "selection bias". [ABSTRACT FROM AUTHOR]

Background: Present day therapeutic modalities for viral warts are mostly ablative in nature, limited by high recurrence rates and are unsuitable for numerous lesions. Immunotherapy has the potential to overcome these limitations.Aims: This study aimed at comparing efficacy and safety of and quality of life changes with intradermal purified protein derivative (PPD) of tuberculin antigen and Mycobacterium w (Mw) vaccine in immunotherapy of warts.Methods: Patients with multiple (≥5) warts were randomized (1:1) into two groups (PPDand, Mw vaccine groups). Fortnightly, 0.1 ml of either medicine was injected intradermally over the deltoidregion till complete resolution or a maximum of six doses. Patients were followed-up for another 3 months for recurrence.Results: Sixty-four participants received either PPD or Mw vaccine. The number of warts were comparable at baseline (P = 0.089, Mann-Whitney test), and reduced significantly with treatment in both groups (P < 0.001, Friedman's ANOVA), as seen from the fourth follow-up onwards with Mw and fifth follow-up onwards with PPD (P < 0.05, Post hoc Dunn's test). Intergroup comparison showed significantly more (P < 0.05, Mann-Whitney test) reduction with Mw than PPD at the sixth and seventh follow-up. The size of warts also reduced significantly (P < 0.001) in both groups from the third follow-up onwards. Complete remission was more (P = 0.539, Fischer's exact test) in the Mw group (68.8%) than the PPD group (50%); and was significantly higher (P = 0.049, Mann-Whitney test) in patients having shorter duration of warts. Adverse events were significantly more (P < 0.001) with Mw including ulceration (50%), discharge (15.6%), pain-swelling-induration and scar at the injection site (97% each), whereas some of those receiving PPD noted erythema and scaling at the injection site (18.8%), and post-inflammatory hyperpigmentation (12.5%). No recurrence was seen till the end of the study.Limitation: Unicentric trial.Conclusion: Intradermal injection of Mw vaccine was more effective but had a higher incidence of adverse effects compared to PPD of tuberculin antigen in patients with warts. [ABSTRACT FROM AUTHOR]

Background: It is a challenge to treat onychomycosis due to frequent treatment failures and relapses. Systemic and topical therapies need to be combined to improve cure rates. Antifungal susceptibility might play a role in the treatment resistance of onychomycosis. Aims: To compare the safety and effectiveness of amorolfine 5% nail lacquer + oral fluconazole versus only oral fluconazole in the treatment of fingernail onychomycosis. Methodology: In this double-blind trial (CTRI/2015/02/005369), patients were randomized (1:1) into amorolfine 5% nail lacquer + fluconazole and dummy lacquer + fluconazole. Treatment was given for 3 months with monthly follow-ups. Antifungal sensitivity was carried out for Candida. Effectiveness was assessed by reduction in the number and percentage area of nails involved and mycological cure. At the end of 3-month treatment period, the association between drug sensitivity and treatment response was explored for the Candida infections. Results: Among 30 study participants, the combination group showed significantly lower number of nail involvement (P = 0.004) and percentage nail involvement (P = 0.005) than only fluconazole group. Pretreatment fungal culture showed a comparable number of dermatophytes, Candida, Aspergillus in both the groups. Sensitivity testing was done for the isolated Candida species. Antifungal sensitivity for Candida (n = 11) was tested, and 8 (72.7%) of the organisms were sensitive to fluconazole (minimum inhibitory concentration [MIC] 1.25 ± 1.19 μg/ml), 100% were sensitive to itraconazole (MIC 0.0726 ± 0.021 μg/ml), and 3 (27.3%) were susceptible-dose dependent (S-DD) to fluconazole (MIC 16 μg/ml). Fluconazole only group patients with Candida who showed resistance to fluconazole did not respond to therapy; however, patients in the combination group showed moderate improvement (reduction in area involvement = 55.56 ± 35.36%). Conclusion: The combination of amorolfine/fluconazole achieved a higher cure rate not only for sensitive fungus but also for those which were S-DD to fluconazole. [ABSTRACT FROM AUTHOR]

Background: Dermatophytosis is becoming increasingly unresponsive to conventional antifungals. Newer topical antifungals may be more effective in these patients.Aims: To evaluate and compare the efficacy and safety of amorolfine 0.25% cream and sertaconazole 2% cream in limited tinea cruris/corporis.Methods: A single-center, randomized (1:1), double-blind, parallel group, active-controlled trial (CTRI/2014/12/005246) was performed. Sixty-six untreated adults with acutely symptomatic tinea cruris/corporis were included in the study. All patients had limited cutaneous involvement and were KOH mount positive. Group A received amorolfine 0.25% cream, and group B received sertaconazole 2% cream twice daily application to the lesions for 4 weeks. After the baseline visit, four follow-up visits were carried out. The outcome measures for effectiveness were clinical and mycological cure. Safety parameters studied were treatment-emergent adverse events and changes in routine laboratory parameters.Results: Both sertaconazole and amorolfine significantly reduced symptoms (P < 0.001) in both groups. However, improvement in symptoms (pruritus, burning sensation, erythema, scaling and crusting) was significantly greater in the sertaconazole group at every follow-up visit. Sertaconazole cream was also more effective than amorolfine cream in reducing the number of lesions (P = 0.002 at 12 weeks) and improving the Dermatology Life Quality Index (P < 0.001) at all the follow-up visits. Adverse events were similar in the two groups (P = 0.117). Fungal cultures became negative in 92.3% of the sertaconazole group as compared to 80% in the amorolfine group (P = 0.010).Limitations: Antifungal susceptibility testing could not be done.Conclusion: Sertaconazole 2% is superior to amorolfine 0.25%, both in terms of effectiveness and tolerability. Improvement can be appreciated from second week onwards. [ABSTRACT FROM AUTHOR]

Background: Acanthosis nigricans has been associated with conditions of insulin resistance such as obesity, polycystic ovary syndrome, and type 2 diabetes. Metformin and alpha-lipoic acid, two types of insulin-sensitizing agents, have been demonstrated to reduce insulin levels and improve insulin sensitivity. Alpha-lipoic acid is available as a fixed-dose combination with biotin, calcium pantothenate, and zinc sulfate as Canthex™. Aims: This study aimed to compare the effectiveness, safety, and improvement of the insulin resistance profile of Canthex™ and metformin in acanthosis nigricans. Materials and Methods: In this double-blind, randomized (1:1), active-controlled trial (CTRI/2017/02/007880), participants received either metformin 500 mg BD or Canthex™ BD for 12 weeks. Effectiveness parameters were improvement of severity of neck lesions and neck texture. Serum fasting insulin level, glucose, lipids, body weight, waist circumference, body mass index (BMI), and homeostatic model assessment-insulin resistance (HOMA-IR) were also assessed at baseline and at the end of the study. Adverse effects and changes in routine laboratory parameters were taken as safety parameters. Results: Thirty-three patients were analyzed by modified-intention-to-treat criteria. Severity of neck lesions and texture were comparable at baseline and it showed significant reduction (P<0.001) in both the treatment arms from the first follow-up onward. No intergroup variation was observed in any of the follow-ups. There was reduction in the values of fasting insulin, blood sugar, total cholesterol, and thyroid-stimulating hormone in both the groups. Weight, BMI, and waist circumference and BMI reduced significantly in both the groups. HOMA-IR decreased significantly in metformin group (P<0.001). Conclusion: Canthex™ is as effective and safe as metformin in the management of acanthosis nigricans and associated features of insulin resistance. [ABSTRACT FROM AUTHOR]

Background: Vitamin B12 deficiency has been associated with peripheral neuropathy, loss of sensation in the peripheral nerves, and weakness in the lower extremities. Methylcobalamin is the most effective analogue of vitamin B12 used to treat or prevent the complications associated with vitamin B12 deficiency. The current study aimed to compare the serum cobalamin levels after administration of two different regimes of methylcobalamin in peripheral neuropathy patients. Methods: The present study was a prospective, randomized, comparative study. The study consisted of two parallel groups, group A (methylcobalamin 500 µg injection intramuscularly three times a week) and group B (methylcobalamin 1500 µg injection intramuscularly once a week). A control group of healthy volunteers was also included. Results: A total of 24 patients (12 in each group) were included in the study. Five healthy volunteers were also included as a control in each group. At the end of treatment, serum cobalamin levels were significantly (P = 0.028) higher in group A (1892.08 ± 234.50) as compared with group B (1438.5 ± 460.32). The serum cobalamin levels in Group A healthy volunteers were also two times higher than that of group B (P = 0.056). Both the LANSS scale and DN4 questionnaire reported similar results at end of treatment. Conclusions: The 500 µg methylcobalamin thrice weekly regime is more effective in increasing the serum cobalamin levels as compared to the 1500 µg methylcobalamin once weekly regime. [ABSTRACT FROM AUTHOR]

Background: Alopecia areata (AA) is an autoimmune characterized by nonscarring loss of scalp and/or body hairs. Topical PUVA has been reported to have good effect in AA. The modification of topical PUVA which we call, "Turban PUVA-sol," is a method of localized immunotherapy using psoralen solution followed by sun exposure. Aims: We aim to study the therapeutic role and side effect profile of turban PUVA in the treatment of advanced and refractory AA. Methodology: Fifteen consecutive patients of alopecia subtotalis (at least 70% of scalp hair loss), totalis, and universalis, attending the dermatology outpatient department of a tertiary care hospital in eastern India were subjected to "Turban PUVA-sol" after duly signed consent. Alternate day therapy was given. Results: At the end of 10 months of study, 2 (13%) out of fifteen patients were lost to follow-up for some unknown reasons. The severity of alopecia tool scores showed a significant (P = 0.0002) decrease posttreatment. Correlation between the severity of alopecia and grade of improvement showed a rho value of -0.453. In the remaining thirteen patients, using physician global assessment (PGA), 4 (26%) showed good response, 4 (26%) showed moderate response, 3 showed mild (20%) response, and 2 patients (13%) showed negligible response. Three out of four patients who showed good improvement in PGA showed more than 80% of new hair growth. Side effects are minimal with some patients complaining of mild irritation and scaling. Conclusion: We found topical Turban PUVAsol to be a very cost-effective and safe treatment option for AA. [ABSTRACT FROM AUTHOR]

Background: Pure neural leprosy (PNL) still remains a diagnostic challenge because of the absence of sine qua non skin lesions of leprosy and a confirmatory diagnostic method. The authors had earlier described a simple yet objective technique of combining fine needle aspiration cytology (FNAC) coupled with a multiplex polymerase chain reaction (PCR) in a pilot study, wherein the technique showed promise of a reliable diagnostic tool. In the pursuit of further evidence, the authors carried out a 4-year study with PNL cases to find the efficacy and reliability of the said method in a larger sample size. Aim: This study was conducted to find the efficacy, reliability, and reproducibility of FNAC coupled with multiplex PCR and Ziehl-Neelsen (ZN) staining in identifying the cases of PNL. Materials and Methods: All cases that were suspected to be suffering from PNL, following evaluation by two independent observers were included in the study and were subjected to FNAC from the affected nerve, and the aspirates were evaluated for cytology, ZN staining, and multiplex PCR for Mycobacterium leprae genome. In addition, serum anti-PGL1 levels were also performed in all the study subjects. Fifteen non-PNL cases were also included in the control arm. Results: A total of 47 cases were included in the test arm and subjected to FNAC. Conventional ZN staining could demonstrate acid-fast bacilli (AFB) in only 15 out of 47 cases (31.91%) while M. leprae DNA could be elicited in 37 (78.72%) cases by the multiplex PCR. Only 13 (27.65%) out of 47 cases showed anti-PGLI-1 antibody positivity. On cytological examination of the nerve aspirates, only 11 (23.40%) cases showed epithelioid cells whereas nonspecific inflammation was seen in 26 (75.60%) cases. Conclusion: The results of this study conducted over a larger sample size corroborate with the findings of our pilot study. In a resource poor set up, FNAC in combination with ZN staining and multiplex PCR is a rapid, simple, and easily performed test, which can give a reproducible and objective diagnosis in cases of PNL. [ABSTRACT FROM AUTHOR]

Background: Chronic urticaria is a vexing problem for patients and treating physicians alike. The EAACI/GA[2]LEN/EDF/WAO guidelines advocate an increased antihistamine dosage up to four times the standard, before adding leukotriene receptor antagonists. Patients are frequently intolerant of these higher dosages. We conducted this study to determine whether the addition of leukotriene receptor antagonists to the standard antihistamine dose was comparable to higher dosages of antihistamines alone, in terms of efficacy, safety and quality of life changes. We compared levocetirizine 10 mg (double dose of standard) versus a combination of levocetirizine 5 mg and montelukast 10 mg in cases of chronic urticaria not responding to single daily dose of 5 mg levocetirizine.Methods: A single-center, double-blind, randomized, active-controlled, parallel group phase IV trial (CTRI/2014/12/005261) was conducted on 120 patients of chronic urticaria of either sex not responding to 5 mg levocetirizine. Patients were randomized into receiving either levocetirizine 10 mg or levocetirizine 5 mg + montelukast 10 mg for 4 weeks. Primary outcome measures were Urticaria Activity Score (UAS) and Urticaria Total Severity Score (TSS). Routine hematological and biochemical tests and treatment-emergent adverse events were monitored for safety.Results: Fifty-two patients on levocetirizine 10 mg group and 51 patients on levocetirizine 5 mg + montelukast 10 mg group were analyzed. UAS and TSS reduced significantly in both treatment groups and reduction of score were comparable in between the groups (P = 0.628, P = 0.824, respectively). Among adverse effects, sedation was noted significantly more (P = 0.013) in levocetirizine 10 mg group. Quality of life was significantly improved in levocetirizine 5 mg + montelukast 10 mg group (P = 0.031).Limitations: The limitation of the study was that the follow-up period was 4 weeks.Conclusion: EAACI/GA[2]LEN/EDF/WAO guidelines need to be more flexible in allowing usage of montelukast before escalation of anti-histamine dosage. [ABSTRACT FROM AUTHOR]

Context: Caregivers of sick children have to be careful with medicine dosing and giving medicines to a reluctant child can be challenging. Aim: To assess the knowledge, attitude, and practices of caregivers regarding pediatric medicine administration and health literacy allied to this task. Settings and Design: This cross-sectional study was carried out on outpatient and inpatient basis in the pediatrics department of a teaching hospital over 6 months. Subjects and Methods: Data regarding sociodemographic profile of patient and caregiver, idea regarding pediatric dosage forms, dosing of medicines, and medication errors during administration were recorded from 377 caregivers. Reconstitution of dry powder and measurement of 5 mL liquid medicine using measuring cup of the medicine phial was demonstrated by the caregivers. Statistical Analysis: Association assessed by point biserial correlation and Spearman's rank correlation. Results: Majority of the primary caregivers surveyed were young, educated, homemaker mothers. Liquid medicines were used maximally (88.9%). Majority (87.3%) of the caregivers used standardized dosing instruments to measure liquids and reconstitution (85.9%), and teaspoon measurement task (91%) was performed satisfactorily by most. Some potentially wrong practices (e.g., adding medicine to milk, redilution of reconstituted medicine, and storing beyond the recommended period) were recorded. Medication errors were reported by 44.5% caregivers, significantly more in the outpatient setting. Although the statistical correlation was weak, the chance of medication error was less, and the precision of measurement was better with increasing education of the caregiver. Conclusions: Physicians need to be aware of the limitations of knowledge and the possibility of wrong administration practices among caregivers of children. Remedial measures in this regard can reduce the risk of medication errors. [ABSTRACT FROM AUTHOR]

Ethics are the moral values of human behavior and the principles which govern these values. The situation becomes challenging for a doctor when he assumes the role of researcher. The doctor-researcher has to serve both the roles and at times the zeal of an investigator has the potential to cloud the morality of the physician inside. It is very important to realize that exploiting the faith of patients is an offence that tantamount to a crime. Medical science is one discipline where the advancement of knowledge is hugely guided by research and mankind has benefitted from many experiments. However benefit and risk are the two faces of the same coin. Various unethical human experiments made us realize that the whims of researchers need to be reined and led to the evolution of the first guidelines for researcher, the Nuremberg code. Thereafter the Good Clinical Practice guidelines serve as the guiding doctrine of clinical research. The principles of ethics rest on the four pillars of autonomy, beneficence, justice, non-maleficence and recently two more pillars are added which includes, confidentiality and honesty. Ethics committees serve as a guardian of these principles. The multidisciplinary Ethics Committee ensures a competent review of the ethical aspects of the project proposal submitted and does it free from any bias or external influence. Ethical review of clinical trial applications follows a decentralized process in India, and requires Ethics Committee approval for each trial site. All Ethics committees have to be registered with Drug Controller General of India (DCGI) without which they cannot approve any clinical trial protocol and has come into effect from 25th February 2013. [ABSTRACT FROM AUTHOR]

Clinical trial related injury and serious adverse events (SAE) are a major area of concern. In all such scenarios the investigator is responsible for medical care of the trial participant and also ethically bound to report the event to all the stakeholders of the clinical trial. The trial sponsor is responsible for ongoing safety evaluation of the investigational product, reporting and compensating the participant in case of any SAE. The Ethics Committee and regulatory body of the country are to uphold the ethical principles of beneficence, justice, non-maleficence in such cases. Any unwanted and noxious effect of a drug when used in recommended doses is an adverse drug reaction (ADR) whereas if causal association is not yet established it is termed adverse event (AE). An AE or ADR that is associated with death, in-patient hospitalization, prolongation of hospitalization, persistent or significant disability or incapacity, a congenital anomaly, or is otherwise life threatening is termed as an SAE. The principal investigator reports the event to the licensing authority (DCGI), sponsor and Chairperson of the Ethics Committee (EC) within 24 hours of occurrence of the SAE. This report is furthered by a detailed report by both the investigator and the EC and given to the DCGI who then gives a final decision on the amount of compensation to be given by the sponsor or the sponsor's representative to the grieving party. [ABSTRACT FROM AUTHOR]

Consenting to participate in a clinical research study after being properly and correctly informed upholds the basic ethical principle of "autonomy" in human research. The informed consent is a process by which the physician sensitizes the patient about the nature, procedures, risks benefits, treatment schedules, etc of the study in a language that is nontechnical and understandable by the study participant. Informed consent document (ICD) has got two parts: the 'Subject Information Sheet' and the 'Informed Consent Form' (ICF); and they have to be approved by the Institutional Ethics Committee (IEC) before administration. Consent should be obtained without any coercion. In case of a situation where a participant is not able to give informed consent (e.g. unconscious, minor or those suffering from severe mental illness or disability) or is illiterate, it has be obtained from a legally acceptable representative (LAR). If the participant or LAR is unable to read/write, then an impartial witness should be present during the entire informed consent process and must append his/ her signatures to the consent form. For children < 7 years, verbal consent is essential and for mature minors (age group 7 to 18 years) informed assent should be obtained. [ABSTRACT FROM AUTHOR]

Background: Current therapeutic modalities for viral warts are mostly ablative and are limited by high recurrence rates besides being unsuitable for numerous lesions. Immunotherapy has the potential to overcome these limitations.Aims: The aim of this study was to compare the effectiveness and safety of Bacillus Calmette-Guerin vaccine versus tuberculin purified protein derivative in the immunotherapy of warts.Methods: Patients received three doses of 0.1 ml of Bacillus Calmette-Guerin vaccine or tuberculin purified protein derivative intradermally over the deltoid region at 4-weekly intervals. They were followed-up for another month. Number of warts, complete cure rates and quality of life were assessed.Results: A total of 60 patients were included. Complete clearance was noted in 16 (48.5%) out of 33 patients in the Bacillus Calmette-Guerin group and in 5 (18.5%) out of 27 in the tuberculin purified protein derivative group (P = 0.121). The number of lesions reduced statistically significantly from baseline in both the groups (P < 0.001) from the first follow-up visit onward (P < 0.05). The reduction was statistically significantly more in the Bacillus Calmette-Guerin group than in the tuberculin purified protein derivative group from the second follow-up onward. Dermatologic life quality index improved statistically significantly with both treatments. Adverse events (pain during injection, abscess formation and scarring at injection site) were more frequent with Bacillus Calmette-Guerin. No recurrence was seen after lesions cleared.Limitations: Patients were not followed up for more than 4 weeks after treatment. We could not estimate the cytokine levels or the peripheral blood mononuclear cell proliferation in response to Bacillus Calmette-Guerin/tuberculin purified protein derivative injections.Conclusion: Both intradermal Bacillus Calmette-Guerin and tuberculin purified protein derivative hold promise in the treatment of viral warts. Bacillus Calmette-Guerin may be more effective, though it had more adverse events in our study. [ABSTRACT FROM AUTHOR]

Background: Toxic epidermal necrolysis and Stevens-Johnson syndrome comprise life-threatening, drug-induced mucocutaneous disease spectrum. Interest in cyclosporine, a calcineurin inhibitor that can block the function of T-cells, has increased with the discovery of the importance of granulysin in apoptosis in toxic epidermal necrolysis. In our hospital, cyclosporine is given to Stevens-Johnson syndrome/toxic epidermal necrolysis patients as an adjunctive therapy.Aims: This study is an observational, record-based study comparing the effectiveness and safety of patients receiving cyclosporine versus only supportive therapy.Methodology: Medical records as bed-head tickets and laboratory investigation reports of Stevens-Johnson syndrome/toxic epidermal necrolysis patients admitted in the hospital over a period of 1 year were collected. Data regarding clinico-demographic profile, suspected drug causing Stevens-Johnson's syndrome/toxic epidermal necrolysis, SCORTEN, body surface area involved, treatment received and outcome were obtained.Results: Twenty-eight patients were analyzed. Nineteen belonged to the cyclosporine group (supportive treatment + cyclosporine), nine to supportive treatment only group. Among the suspected drugs, antiepileptics formed the major group (28.6%). Five patients in the supportive only group and one in the cyclosporine group died. Time for stabilization and reepithelialization and duration of recovery were significantly lower in the cyclosporine group (P < 0.001, P= 0.007, P= 0.01, respectively). The standardized mortality ratio was 0.32 in cyclosporine group which is nearly 3.3 times lower than the only supportive treatment.Limitations: As it was a record-based study, certain confounding factors (serum blood urea nitrogen) could not be adjusted.Conclusion: Cyclosporine (5 mg/kg/day) for 10 days from onset of Stevens-Johnson syndrome/toxic epidermal necrolysis may decrease the risk of dying, may provide faster healing of lesions and might lead to early discharge from hospital. [ABSTRACT FROM AUTHOR]

Background Type 2 lepra reaction (T2R) is a difficult-to-manage condition in leprosy, and an effective and safe steroid-sparing agent is needed for its management. The World Health Organization proposes clofazimine and recommends pentoxifylline for T2R. Our study was done to compare the effectiveness and safety of clofazimine and pentoxifylline therapy in patients with T2R. Methods Twenty patients with T2R were randomized equally. Group A received pentoxifylline 400 mg t.d.s, group B received clofazimine 100 mg t.d.s. for 12 weeks. Both groups received prednisolone 40 mg o.d., tapered over 12 weeks. The effectiveness parameters were days needed for resolution of cutaneous and systemic manifestations, relapses, cutaneous score, systemic score, and average daily prednisolone intake. Safety parameters were spontaneously appearing adverse events and laboratory parameter changes. Results The cutaneous scores in the clofazimine ( P < 0.001) and pentoxifylline groups ( P < 0.001) showed a progressive decline in subsequent follow-ups. Individual follow-ups were significantly lower than baseline in both groups ( P < 0.05). Systemic scores fared similarly. There were no significant intergroup changes. Average daily prednisolone intake progressively decreased in group B ( P < 0.001). Cutaneous and systemic manifestations took a comparable time to resolve. Both drugs were safe. Conclusion Pentoxifylline effectively reduces initial severity; clofazimine provides sustained improvement but acts slowly. [ABSTRACT FROM AUTHOR]

Background: Pityriasis rosea (PR) is an acute inflammatory dermatosis. The association of human herpes virus 6 and 7 suggests the utility of use of antiviral agents in this disease. Aims and Objectives: To evaluate the effectiveness and safety of acyclovir in the treatment of PR. Methods: An observer-blind, randomized (1:1), parallel group, add-on trial was conducted on 24 adult patients with PR. Subjects of both Group A and B received the standard of care in the form of cetirizine 10 mg OD and calamine. Group A in addition received acyclovir 400 mg tablets thrice daily for 7 days. Both groups were followed up for four consecutive weeks for assessment of effectiveness and adverse events. Results: Group A complained of significantly fewer new lesions than Group B (P = 0.046). A complete response was obtained in all patients of Group A and 83% patients of Group B at the end of the follow up period. There was significant reduction in both lesional score and pruritus at second week follow-up in Group A and third week follow-up in Group B (P < 0.05). Minor adverse effects were observed in both treatment arms. Conclusion: Acyclovir offered rapid resolution of clinical severity of PR from second week onwards without significantly increased adverse events as compared to supportive therapy alone. [ABSTRACT FROM AUTHOR]

Background: In spite of the availability of multiple treatment options, viral warts are known for their persistence and recurrence, causing frustration to patients and treating physicians.Aims: To study the effectiveness and safety of autoinoculation as a treatment modality in cutaneous warts.Methods: A double-blind, placebo-controlled study was carried out. In the treatment group, full-thickness warty tissue was excised, minced and implanted in a small dermal pocket. In the control group, warty tissue was only excised and not implanted, though a dermal pocket was made. Patients were evaluated every four weeks with lesion counts. The procedure was repeated at 4 and 8 weeks. Response was assessed at each visit and at 12 weeks.Results: Forty-eight patients with cutaneous warts (male: female=32:16) were randomized into autoinoculation and control groups. The number of warts at baseline was comparable in both groups (P=0.293). Reduction in the number of warts was significantly more in the autoinoculation group (8.50±13.88) than in the control group (10.04±5.80) from 8 weeks onwards (P=0.010). Complete resolution occurred only in the autoinoculation group, in 62.5% of cases. Adverse effects were seen in 11 patients, including infection of the donor site (5 cases), keloid formation (3) and hypopigmentation (3).Conclusion: Autoinoculation may be an effective therapeutic modality for cutaneous warts and two sessions may be required for optimum results. [ABSTRACT FROM AUTHOR]

Background: In spite of the availability of multiple treatment options, viral warts are known for their persistence and recurrence, causing frustration to patients and treating physicians. Aims: To study the effectiveness and safety of autoinoculation as a treatment modality in cutaneous warts. Methods: A double-blind, placebo-controlled study was carried out. In the treatment group, full-thickness warty tissue was excised, minced and implanted in a small dermal pocket. In the control group, warty tissue was only excised and not implanted, though a dermal pocket was made. Patients were evaluated every four weeks with lesion counts. The procedure was repeated at 4 and 8 weeks. Response was assessed at each visit and at 12 weeks. Results: Forty-eight patients with cutaneous warts (male: female = 32:16) were randomized into autoinoculation and control groups. The number of warts at baseline was comparable in both groups (P = 0.293). Reduction in the number of warts was significantly more in the autoinoculation group (8.50 ± 13.88) than in the control group (10.04 ± 5.80) from 8 weeks onwards (P = 0.010). Complete resolution occurred only in the autoinoculation group, in 62.5% of cases. Adverse effects were seen in 11 patients, including infection of the donor site (5 cases), keloid formation (3) and hypopigmentation (3). Conclusion: Autoinoculation may be an effective therapeutic modality for cutaneous warts and two sessions may be required for optimum results. [ABSTRACT FROM AUTHOR]

Background: Chronic urticaria (CU) is a vexing problem and patients of CU suffer from the morbidity that arise from irritable itch and weals and are also subjected to a huge antihistamine pill burden. The symptoms are more in autoreactive urticaria (AU) where auto-antibodies in blood flares-up the condition. Search for newer effective modalities which can reduce pill burden is a felt need. Aims: This study evaluates the effectiveness of autologous serum therapy (AST) in CU and also determines its usefulness in AU. Materials and Methods: Double blind, parallel group, randomized, controlled study. Fifty four patients were given AST and 57 patients were given injection normal saline (placebo), along with cetirizine in an on-demand basis in both groups. AST/Placebo was given weekly for nine weeks and followed-up for a total period of 24 weeks. AU was diagnosed by autologous serum skin test. Urticaria total severity score (TSS), Urticaria activity score (UAS), Dermatologic life quality index (DLQI) was used as primary effectiveness variables. Safety parameters assessed were the spontaneously reported adverse events and laboratory parameters. Results: TSS showed significant improvement from baseline, 7 th week and 8 th week onwards in AST group and placebo group respectively. Group comparison showed significant improvement 4 th week onwards. UAS showed similar results. DLQI showed significant improvement in AST group compared to placebo at the end of study. Both AU and non-AU patients showed comparable improvement of TSS. Conclusion: AST shows promise in treatment of urticaria regardless of the autoreactive nature. [ABSTRACT FROM AUTHOR]

Aim: Selective serotonin reuptake inhibitors (SSRI) and serotonin-norepinephrine reuptake inhibitors (SNRI) are effective in treating anxiety disorders associated with major depressive disorder (MDD). This randomized, controlled, parallel-group, open-label, phase 4 trial (CTRI/2012/08/002895) was undertaken to compare the effectiveness and safety of desvenlafaxine versus escitalopram, a standard antidepressant. Materials and Methods: Effectiveness was assessed using the Hamilton Depression Rating Scale (HAM-D17) and Hamilton Anxiety Rating Scale (HAM-A). Response to treatment was assessed by ≥50% decrease of baseline scores (responder rate). Safety and tolerability was evaluated by changes in routine laboratory parameters, vital signs, and adverse events reported by the subject and/or observed by the clinician. Results: Responder rates for both HAM-A and HAM-D scores at 8 weeks were better in the escitalopram group compared to the desvenlafaxine group (HAM-A 76.92% vs. 71.05%; HAM-D 79.48% vs73.68%) but the differences were not statistically signifi cant (P = 0.59 and P = 0.61). Within group changes of both scores, from baseline to subsequent visits in both treatment arms were statistically signifi cant (P < 0.01). Conclusion: The effectiveness of desvenlafaxine was comparable to escitalopram, but escitalopram was better tolerated. [ABSTRACT FROM AUTHOR]

Objectives: Chronic urticaria (CU) is characterized by frequent appearance of wheals for ≥6 weeks. This study was undertaken to compare effectiveness and safety of olopatadine, a newer antihistamine with additional anti-inflammatory properties, in treating CU in comparison to the established second-generation antihistamine levocetirizine. Methods: A single center, assessor-blind, randomized (1:1), active-controlled, parallel group, Phase IV trial (CTRI/2011/08/001965) was conducted with 120 adult CU patients of either sex. Subjects received either olopatadine (5 mg b.i.d.) or levocetirizine (5 mg/day) for 9 weeks, continuously for first 4 weeks and then on demand basis for last 5 weeks. Primary outcome measures were urticaria activity score (UAS) and urticaria total severity score (TSS). Routine hematological and biochemical tests and treatment-emergent adverse events were monitored for safety. Results: Data from 54 subjects on olopatadine and 51 on levocetirizine were analyzed for effectiveness. UAS and TSS values declined significantly with both drugs over the treatment period but the reduction was greater with olopatadine. Adverse event profiles were comparable with sedation being the commonest complaint. Conclusions: Olopatadine is a safe and more effective alternative to levocetirizine in the treatment of CU. [ABSTRACT FROM AUTHOR]

Background: Superficial fungal infections are common and treatment imposes economic burden on the patients. Government of India had introduced price control over griseofulvin and tolnaftate in 1995; however, this measure can only benefit the needy if the policy is harmonized with the health-care service provider, that is, dermatologists. The aim of this study was to evaluate the existing Government mechanisms over price control of antifungal medications and its reach to the people-in-need. Materials and Methods: A questionnaire-based, cross-sectional study was carried out over a period of 6 months. Questionnaire was mailed to members of a state branch of Indian Association of Dermatologists, Venereologists, and Leprologists. Responses reaching investigators within 2 months from the date of mailing were finally analyzed. Results: Among 93 (41.33%) respondents, only 6 (6.5%) were aware of existing price control over griseofulvin but none about tolnaftate. Thirty-nine (41.9%) respondents were in favor of introducing price control on terbinafine and 42 (45.2%) for itraconazole. The topically preferred antifungals were primarily azoles and terbinafine, while among systemic antifungals, dermatologists mostly preferred fluconazole and terbinafine. The choice of antifungals by the dermatologists matched with the evidence-based dermatology data. Conclusion: Currently, price-controlled antifungal drugs are less commonly used by practitioners. Although the dermatologists favor price control, the initiative undertaken by the Government has not reached them. This shows the need to bridge the gap between policy makers and health-care service providers to help the ailing population. [ABSTRACT FROM AUTHOR]

Introduction: Epilepsy is a chronic disease and neurocysticercosis is an important cause of secondary seizures. Its therapy is modified by a number of parameters and thus the pattern of anti-epileptic drugs used varies in different clinical settings. It was our objective to evaluate clinico-demographic and treatment profile of epilepsy patients attending neurology outpatient department, efficacy and side-effect profile of anti-epileptic drugs with special emphasis on epilepsy resulting from neurocysticercosis. Materials and Methods: This was a cross-sectional descriptive study of epilepsy patients over four months in neurology outpatient department. Clinico-biological data were obtained by interrogating patients and from recorded data using standard case-report form. Results: 79 patients were studied with 54.43% having primary etiology, 40.51% having seizures secondary to neurocysticercosis. 81% had generalized tonic-clonic seizure, 17.7% partial and 1.3% myoclonic seizures. Phenytoin (86.08%), valproate (30.38%), clobazam (26.58%) and carbamazepine (10.13%) were used either alone or in combination, with no use of anthelmintics even in cases of neurocysticercosis. Control of seizure was obtained in 79.7% with significant decrease in seizure frequency from 2.92 to 0.51 (P < 0.0001). Weight loss, nausea, decreased appetite, increased sleep, drowsiness, tremors were found to be significantly associated (P < 0.05) with phenytoin use. Conclusion: Phenytoin is the primary antiepileptic in spite of its side effects; though addition of other anti-epileptic drugs (valproate, clobazam) was required for better seizure control. Cases of neurocysticercosis respond to anti-epileptic drugs without addition of anthelmintics. Side effects observed were mostly neurological in nature. [ABSTRACT FROM AUTHOR]

Background Diagnosing leprosy is challenging, especially in early-stage cases, and the need for a sensitive diagnostic tool is urgent. Polymerase chain reaction (PCR) holds promise as a simple and sensitive diagnostic tool, but its usefulness in the Indian context requires further evaluation. Slit-skin smear (SSS) remains the conventional method of leprosy detection. Hence, this study was undertaken to evaluate and compare the diagnostic efficacy of PCR versus that of SSS. Methods Punch biopsy of skin and SSS were obtained from the active margins of lesions. Cases were clinically grouped according to whether they were multibacillary (MB) or paucibacillary (PB) and classified into tuberculoid (TT), borderline tuberculoid (BT), borderline lepromatous (BL), lepromatous (LL), histoid, and indeterminate groups after clinicopathological correlation. DNA was extracted from biopsy specimens, and multiplex PCR was carried out incorporating primers intended for the amplification of a specific 372-bp fragment of a repetitive sequence of Mycobacterium leprae DNA. Results Among 164 patients, PCR was positive in 82.3%. The sensitivity of PCR was significantly greater ( P < 0.0001) than that of SSS in both the MB (85.9% vs. 59.8%) and PB (75.4% vs. 1.8%) subgroups; the difference in sensitivity in the PB subgroup is remarkable. Positivity by PCR and SSS was found in 100% of LL and histoid leprosy, but PCR had significantly greater ( P < 0.0001) positivity in BT leprosy and was of definite increased value in indeterminate and TT leprosy. Conclusions Polymerase chain reaction had higher sensitivity compared with SSS, especially in diagnostically challenging and PB cases. Thus, the use of this costly but sensitive tool should be restricted to this subgroup, because SSS is sufficiently sensitive in the diagnosis of LL and histoid leprosy. [ABSTRACT FROM AUTHOR]

Erythema multiforme (EM) is an acute, self-limited, Type IV hypersensitivity reactions associated with infections and drugs. In this case of acute promyelocytic leukemia, EM diagnosed during the induction phase was mistakenly attributed to vancomycin used to treat febrile neutropenia during that period. However, the occurrence of the lesions of EM again during the consolidation phase with arsenic trioxide (ATO) lead to a re-evaluation of the patient and both the Naranjo and World Health Organization-Uppsala Monitoring Centre scale showed the causality association as "probable." The rash responded to topical corticosteroids and antihistamines. This rare event of EM being caused by ATO may be attributed to the genetic variation of methyl conjugation in the individual which had triggered the response, and the altered metabolic byproducts acted as a hapten in the subsequent keratinocyte necrosis. [ABSTRACT FROM AUTHOR]

Thalidomide developed in 1954 for morning sickness had proven to be a teratogen and hence was withdrawn from market. Resurgence of thalidomide began as an immunomodulator when it was shown to be effective in the management of multiple myeloma and many conditions like erythema nodosum leprosum, graft versus host disease, recurrent aphthous ulcers etc. We report a case of Stevens Johnson syndrome-toxic epidermal necrolysis developing in an elderly male who was prescribed thalidomide after being diagnosed with multiple myeloma. [ABSTRACT FROM AUTHOR]

The article discusses the importance of registering a trial in a public access trial registry prior to beginning of the trial in World Health Organisation (WHO) registry. It mentions that Clinical Trial Registry ‑ India (CTRI) is a free and online public record system for authorization of clinical trials conveyed in India. It provides information on what to register, when to register, and how to register a clinical trial in India. It also provides tips for registration.