Clinical Use of Super Bioavailable Itraconazole for the Management of Dermatophytosis: Consensus Statement by Dermatologists from India via the Modified Delphi Technique.

INTRODUCTION: Super bioavailable itraconazole (SB ITZ) overcomes the limitations of conventional itraconazole (CITZ) such as inter-individual variability and reduced bioavailability. It has been approved for systemic mycoses in Australia and Europe as 50mg and the United States as 65mg and in India as 50mg, 65mg, 100mg, and 130mg. However, data on the ideal dose and duration of SB ITZ treatment in managing dermatophytosis is insufficient. This consensus discusses the suitability, dosage, duration of treatment, and relevance of using SB ITZ in managing dermatophytosis in different clinical scenarios. METHODS: Sixteen dermatologists, (>15 years of experience in the field and ≥2 years clinical experience with SB ITZ) formed the expert panel. A modified Delphi technique was employed, and a consensus was reached if the concordance in response was >75%. RESULTS: A total of 26 consensus statements were developed. The preferred dose of SB ITZ is 130mg once daily and if not tolerated, 65mg twice daily. The preferred duration for treating naïve dermatophytosis is 4-6 weeks and that for recalcitrant dermatophytosis is 6-8 weeks. Moreover, cure rates for dermatophytosis are a little better with SB ITZ than with CITZ with a similar safety profile as of CITZ. Better patient compliance and efficacy are associated with SB ITZ than with CITZ, even in patients with comorbidities and special needs such as patients with diabetes, extensive lesions, corticosteroid abuse, adolescents, and those on multiple drugs. CONCLUSION: Expert opinions indicate that overall clinical experience with SB ITZ is better than that with CITZ.

Clinical Evaluation of the Safety and Tolerability of Film-Forming Sprays in Patients With Psoriasis and Eczema.

Background Treating dermatological pathologies under occlusion therapy is a popular adjunct, especially in thickened, lichenified areas of psoriasis where sustained contact with topical corticosteroids plays a pivotal role. Film-forming spray (FFS) can be a novel, alternate approach along with topical treatment in this area for carefully selected cases. This study aimed to evaluate the safety profile and physical characteristics of a novel formulation of an FFS in patients with psoriasis and eczema.  Methods This open-label, multicentre, comparative study included subjects diagnosed with chronic plaque psoriasis requiring topical corticosteroid therapy or those with eczema necessitating its application and occlusion therapy. The study product was applied to two groups of subjects. For patients in group 1, the FFS was applied to the skin area affected by the dermatological condition, which was covered with ointment only. In the second group, the FFS was applied to the corresponding unaffected skin area. The FFS was applied for 60-90 seconds and was observed for two hours after the application. The subjects were evaluated for primary outcomes, including safety assessment, overall physical characteristics, and appearance of FFS from local skin effects. The secondary outcomes included physical appearance characteristics and overall patient satisfaction following the application of FFS at the target sites. Further statistical assessments were conducted using the SAS software version 9.4 (2023; SAS Institute Inc., Cary, North Carolina, United States). Result A total of 100 subjects were included in the study across 10 outpatient centers, of which 79% had psoriatic plaques and 21% had eczematous lesions. Primary outcomes showed a lack of appearance of clinical symptoms such as dryness, flakiness, or irritation. A total of 10% of subjects in group 1 had erythema, and 6% had a tingling sensation, which was transient and mild. The secondary outcomes showed that only 12% of subjects in Group 1 and 6% of subjects in Group 2 showed a feeling of stickiness at the application site. In group 1, 8% reported a cooling sensation, which disappeared in one and two minutes, and none experienced a cooling sensation in Group 2. The average drying time for FFS in subjects with dermatological conditions was 5.19 minutes compared to 1.51 minutes on unaffected skin. The film washability results indicated that 96% of subjects in group 1 reported complete removal in less than two minutes. At the end of the study period, the mean satisfaction score was 8.99. No significant adverse events were reported in the patients. Conclusion This study highlights the potential application of a novel formulation of FFS as a safe and well-tolerated option for enhancing uniform skin coverage with the topical corticosteroid in patients affected with psoriasis and eczema.

IADVL SIG Recalcitrant Dermatophytosis Position Statement on Super Bioavailable Itraconazole.

Itraconazole (ITZ) has been the mainstay of oral antifungal treatment for the current epidemic of recalcitrant dermatophytosis (RD) in India. Recently, a newer formulation of ITZ, super bioavailable itraconazole (SUBA-ITZ), is made available in the market by many pharmaceutical companies. It is important for dermatologists to understand the pharmacokinetic properties of SUBA-ITZ vis-a-vis conventional pellet formulation to use it effectively and safely. Indian Association of Dermatologists, Venereologists and Leprologists (IADVL) has established a special interest group for recalcitrant dermatophytosis (SIG-RD) to strengthen research, continuing medical education, and industry collaboration on the subject. This position statement on SUBA-ITZ by SIG-RD is an attempt to address current pieces of evidence and the position of this new formulation in the management of RD.

Koebnerization of Lichen Sclerosus Et Atrophicus at Insulin Injection Sites - A Rare Case with Dermoscopic Features.

Lichen sclerosus et atrophicus (LSEA), also known as lichen sclerosus (LS), is a disabling, cosmetically disfiguring condition predominantly affecting the anogenital region of pre- and postmenopausal females. Extragenital LS is relatively less common and occurs predominantly on the trunk and neck. Koebnerization or isomorphic phenomenon is reported occasionally in LS after trauma like radiotherapy. A few case reports describe koebnerization of LS at injection sites. We describe the first such case in India of LS koebnerizing at insulin injection sites with dermoscopic features.

Scrotal Lymphangiectasia with Penile Elephantiasis in Underlying Lymphatic Filariasis-Challenging the Diagnostic Mind! A Case Report.

BACKGROUND: A plethora of diseases manifest as acquired genital lymphangiectasias which clinically manifest as superficial vesicles. They range from infections such as tuberculosis to connective tissue diseases such as scleroderma and even malignancy. Amongst infectious etiologies, lymphatic filariasis leads as the cause for lymphatic obstruction. Despite this, acquired lymphangiectasias due to this cause are not commonly reported. An unusual case of acquired scrotal lymphangiectasia secondary to filariasis is detailed in this paper with dermoscopic and histologic findings. METHODS: A 65-year-old male farmer presented with multiple, asymptomatic vesicles over the scrotum with thickened scrotal and penile skin that had occurred for six years. He gave past history of intermittent fever and milky urine, was diagnosed with filariasis and treated with diethylcarbamazine for a year, four years previously. Systemic complaints abated but the peno-scrotal lesions did not. RESULTS: Polarized dermoscopy revealed multiple skin-colored nodules and translucent pale blue lacunae over the scrotum. A few radially arranged linear irregular vessels were noted over the nodules. On histopathology, multiple ectatic lymphatics were noted in the mid and upper dermis with acanthosis and superficial perivascular lymphocytes. Peripheral smear revealed eosinophils; however, microfilariae could not be detected despite repeated diethylcarbamazine provocation and night smears being taken. The findings were compatible with acquired scrotal lymphangiectasia secondary to treated lymphatic filariasis. Local hygiene was advised; however, procedural treatments were refused by the patient. CONCLUSION: Herein, we report an unusual case of acquired scrotal lymphangiectasia of the scrotum secondary to treated lymphatic filariasis. Very few similar reports exist. To the best of our knowledge, dermoscopic features of this condition have not been elucidated before. This case, detailing an uncommon manifestation of a common disease (filariasis), demonstrates the importance of careful history taking and examination. This was especially so in the present case since only circumstantial evidence of filariasis was noted in investigations. There is a need to heighten awareness of this unusual condition amongst physicians especially if the patient hails from an area endemic for filariasis.

Clinical, bacteriological, and histopathological characteristics of newly detected children with leprosy: a population based study in a defined rural and urban area of Maharashtra, Western India.

BACKGROUND: Leprosy has been a major public-health problem in many developing countries for centuries. According to the National Leprosy Elimination Programme report of March 2012, there were a total of about 0.13 million cases of leprosy in India, 9.7% of which were children. Numerous studies have investigated child leprosy amongst reported cases however, studies pertaining to proportion and characteristics of undetected childhood cases in the community are very few. AIM: To examine the clinical, bacteriological, and histopathological characteristics of newly detected child leprosy cases in the community. METHODS: The population survey conducted from June to September 2007 and the defined rural areas, which included five primary health centers of Panvel Taluka, in Raigad district and urban areas, which included M-east ward of the municipal corporation of greater Mumbai of western Maharashtra, India. RESULTS: House-to-house survey yielded 32 and 37 so far, undetected child cases of leprosy in the rural and urban region, and the prevalence rate was 10.5 and 1.5 per 10,000, respectively. The age of child leprosy cases detected, ranged from 3 to 14 years with a mean of 10.06 ± 3.35 years in the rural and 9.97 ± 3.12 years in the urban area. Most of the cases were paucibacillary (62%). A large proportion of children (49%) had single skin lesion (SSL). Of the 19 SSL cases examined histopathologically, 15 (99%) showed features of borderline tuberculoid, 1 (5%) borderline lepromatous and 3 (16%) had indeterminate type of leprosy. Tuberculoid leprosy was not seen in any, indicating less likelihood of self-healing. Overall, three cases had deformity (grade 1 = 1 and grade 2 = 2) and 31% of multibacillary cases were smear positive. CONCLUSION: The clinical, bacteriological, and histopathological characteristics of newly detected child cases in the community evidently indicate the grave nature of the problem of undetected child leprosy, recent active transmission, and highlight implications on individual patients and the community. KEY MESSAGE: Most of the cases were paucibacillary (62%). A large proportion of children (49%) had SSL and (55%) had it on the face followed by arms and leg (27%) and trunk (17%). The mean duration of symptoms exceeded one year which can be attributed to poor knowledge of leprosy or barriers in access to health care or its utilization.

BCG immunotherapy as an adjunct to chemotherapy in BL-lL patients--its effect on clinical regression, reaction severity, nerve function, lepromin conversion, bacterial/antigen clearance and 'persister' M. leprae.

BACKGROUND AND OBJECTIVE: Multidrug therapy in leprosy has failed to eliminate the problem of persister bacilli. Clearance of bacterial antigens is extremely slow which could predispose to continued nerve damage even after release from treatment. In the present study the immunomodulatory efficacy of BCG vaccine administered post-MDT in BL-LL leprosy patients was investigated in depth with a view to determining if augmenting chemotherapy with immunotherapy would help in faster clearance of M. leprae/antigens, bring down the level of persisters and minimise the occurrence/severity of reaction and nerve damage. METHODS: This is a placebo-controlled study in treated BL-LL patients. The patients are matched with respect to age, sex, bacteriological index and history of reaction, stratified and allocated to the two groups. One group (Gr A) received two doses of BCG-MOSCOW (3-33 x 10(5) cells) and the other (Gr B) normal saline (0.85%), injected intra-dermally at 3 month intervals. The Primary outcomes assessed at the end of 6 months were bacterial/antigen clearance, lepromin conversion, granuloma clearance and the occurrence of persisters. The secondary outcomes were clinical regression, occurrence and severity of reaction and changes in nerve functions. MATERIAL: A total of 107 BL-LL patients comprised of 49 in Gr A and 58 in Gr B; of which 36 and 42 respectively completed the study as per protocol, and are included in the final analysis. FINDINGS: The study findings show that both the primary and the secondary out comes were comparable in the two groups. Two doses of BCG administered post-MDT (Gr A) did not significantly alter the level of persisters or help in hastening the bacterial/antigen clearance, clinical regression of lesions and granuloma clearance. Lepromin conversion rates were also comparable. While the frequency of lepra reaction/neuritis following the intervention was comparable, the severity of reactions was significantly higher in Gr A. On the positive side neural functions assessed by nerve conduction studies showed that deterioration of motor nerve conduction was significantly lower in the BCG arm. Since all patients developing moderate to severe reactions, immediately received a course of corticosteroids, it is possible that timely use of it might have helped.

Spectacular skin nodules: cutaneous necrobiotic xanthogranuloma without paraproteinemia.

Necrobiotic xanthogranuloma (NXG) is a very rare, progressive variant of non-Langerhans cell histiocytosis. It is known to be associated with multisystem involvement and paraproteinemias. A 65-year-old female presented with chronic, slowly growing, asymptomatic periorbital nodules. The lesions had recurred after local excision elsewhere. No systemic involvement or paraproteinemias were detected. A provisional diagnosis of isolated cutaneous NXG was made which was confirmed by histopathology and immunohistochemistry staining. The lesions were surgically excised with excellent cosmetic and functional results. There was no recurrence over a period of 9 months. To our knowledge, this is the second case of NXG reported from India and the first without any systemic manifestations.

Clinical, bacteriological and histopathological study of 62 referral relapse cases between Jan 2004 and Dec 2009 at the Foundation for Medical Research, Mumbai.

UNLABELLED: Sixty two patients with relapsed leprosy seen between Jan 2004 and Dec 2009 were studied using clinical, bacteriological and histopathological parameters. The findings thus obtained were correlated to parameters such as trend and source of referral, clinical characteristics at diagnosis, treatment received, other events during or after RFT and duration between cessation of treatment and relapse. FINDINGS: Referrals per year have doubled since 2006. Most patients were referred by NGOs (58%), followed by Govt. hospitals (16%) and then by GPs (25%); 76% had received one of the WHO - MDT regimens including 16 treated with 24 months or more MB - MDT, 23 with 12 months MB - MDT and eight with 6 months PB - MDT. Of the remaining 14 cases, four had received DDS mono-therapy, seven had single dose of Rifampicin, Ofloxacin and Minocycline (ROM) and four Rifampicin and Ofloxacin (RO) daily for 28 days. The average incubation time of relapse, defined as duration between cessation of treatment and relapse was (SD) + 6-4 years. 59% of patients had positive slit skin smears on relapse. Relapse for the second time occurred in six BL cases including five from group 2 and one RO treated patient and 11/23 cases from group 2 conferred to BT-BB leprosy. Clinical features at diagnosis and on relapse were comparable in 47% of cases. CONCLUSION: All leprosy patients, regardless of their type and MDT regime, carry 'risk of relapse'. A shorter treatment duration reduces the incubation time to relapse. In group 2 (treated with 12 months MB-MDT regime) 11/23 were BT-BB cases and 5/23 (21%) were relapse for the second time, which further supports our earlier documented findings and maybe the efficacy of WHO-MDT regime is poor in a small subset of patients.

The effect of corticosteroids usage on bacterial killing, clearance and nerve damage in leprosy; part 3--Study of two comparable groups of 100 multibacillary (MB) patients each, treated with MDT + steroids vs. MDT alone, assessed at 6 months post-release from 12 months MDT.

OBJECTIVE: To investigate effects of therapeutic usage of corticosteroids on M. leprae killing and clearance, on clearance of granuloma and on nerve damage in multibacillary (MB) leprosy patients. DESIGN: From a cohort of 400 untreated MB patients, a comparable group of 100 each receiving MDT + steroids (group A) vs MDT alone (group B) were assessed at 18 months as compared to month zero with respect to clinical and granuloma regression, M. leprae killing and clearance, and nerve functions. Analysis was performed using SPSS version 10.0. The significance of association was tested using Chi square and Fisher's exact tests. RESULTS: Regression of lesions assessed clinically and by histopathology was seen in 52% and 53% patients in group A and 46% and 63% in B respectively (P not significant). Clearance of bacteria assessed by bacteriological index (BI) in slit skin smears (SSS) and extent and intensity of antigen using anti-BCG staining were also comparable in the two groups. Multiplication of M. leprae in the mouse foot pad (MFP) indicating the presence of viable bacilli was seen in 14% and 16% of SSS positive BL-LLs patients in groups A and B respectively (P not significant). The occurrence of viable M. leprae was higher among patients with repeat reaction (19%) than single (11%). Using clinical tests (nerve palpation, monofilament and voluntary muscle testing), the proportion of sensory and motor nerves showing improvement or deterioration were similar in the two groups. However using nerve conduction studies, the overall proportion of nerves showing deterioration (22%) was significantly higher than improvement (9%) (P < 0.001). CONCLUSIONS: Treatment with MDT + corticosteroids does not adversely affect the clearance of granuloma, M. leprae and/or its antigens and M. leprae killing. However the continued presence of viable bacteria in > 14% of BL-LLs patients indicate that 12 months of MDT may be insufficient for complete bacterial killing. In both groups nerve conduction studies indicated that deterioration of nerves was high suggesting, MDT + corticosteroids was not very efficacious in the prevention or reversal of nerve damage. A better immuno-modulatory drug or a modified corticosteroid regime is needed.

Effect of corticosteroid usage combined with multidrug therapy on nerve damage assessed using nerve conduction studies: a prospective cohort study of 365 untreated multibacillary leprosy patients.

The purpose of this study is to determine the extent of nerve involvement and to study the effect of corticosteroids combined with multidrug therapy on nerve damage in leprosy patients using sensory and motor nerve conduction studies. A cohort of 365 untreated multibacillary leprosy patients were prospectively studied using sensory and motor nerve conduction studies on upper and lower limb nerves. They were subgrouped as those to be treated with 12-week regimen of corticosteroids for reaction and/or neuritis or silent neuropathy of <6 months duration along with 12-month multidrug therapy (group A), and those with no reaction were treated with multidrug therapy only (group B). Analysis was performed using SPSS version 10.0. Significance of association was tested using chi(2) test. At registration, abnormality by nerve conduction studies was seen in 92% of patients and majority (65%) showing involvement of more than five sensory and motor nerves. Sensory nerve abnormalities were higher (52%) than motor (37%) (P < 0.001). Affection of sensory and motor nerves was higher in group A (P < 0.001). Notably, 40% nerves in group B also showed impairment at 0 month. This implies that almost all patients showed abnormal nerve conduction studies at onset regardless of reaction, proving nerve damage is more widespread than envisaged. At 18 months, overall percentile deterioration (23%) of nerves was higher than improvement (9%) (P < 0.001) indicating that corticosteroids combined with multidrug therapy failed to significantly improve the nerve status. Sensory nerve (57%) affection was significantly higher than motor (46%) (P < 0.001). Moreover, percentile deterioration of sensory nerves was higher in group A (P < 0.001) implying corticosteroids is not very efficacious in the prevention or reversal of nerve damage. Electrophysiological tests provide valuable information for detecting nerve function impairment and evaluating appropriate therapeutic regimens.

Detección de casos de lepra nuevos en un área rural y urbana de maharashtra, del oeste de india / No disponible

Introducción: La lepra ha constitución un problema de salud pública en la India durante siglos. En este país, entre 2001 y 2005, la prevalencia de la lepra se ha reducido un 80%. Este brusco declive en la prevalencia de la enfermedad y la falta de una vigilancia y control activo es motivo de alarma en la comunidad científica. Material y métodos: Se trata de un estudio que abarca toda la población con el propósito de intentar evaluar la prevalencia de los casos activos de lepra sin detectar en la comunidad en una zona rural definida (Panvel Taluka, Distrito Raigad) y urbano (Pabellón M-Este, Mumbai) por medio del personal sanitario de Kushth Nivaran Samiti (Panvel) y Lok Seva Sangam (Mumbai). Los que fueron diagnositcados provisionalmente de lepra pasaban a una verificación independiente mediante examen clínico, bacteriológico e histopatológico en la Fundación para la Investigación Médica. Hallazgos: Se cribaron 196,694 y 600,247 individuos de un área rural y urbana respectivamente. En el área rural, el examen de 178,646 individuos reveló 120 casos provisionales de lepra, de los cuales 65 eran paucibacilares (PP) y 55 multibacilares (MB) basado en la clasificación OMS empleada por el personal sanitario en el campo. En la zona urbana, el examen 512,454 personas reveló 92 PB y 42 MB. De entre los casos clínicos confirmados, 35.6% (32/90) y 34.9% (36/109) en zona rural y urbana respectivamente, fueron niños. Conclusiones: Hay muchos casos de lepra sin detectar en la comunidad con una elevada proporción de casos MB y en niños. Esto indica una transmisión activa que exige un cambio de estrategia en los programas de control de lepra (AU)

Introduction: Leprosy has been a major public health problem in India for centuries. In India, between 2001 and 2005, the prevalence of leprosy was reduced by 80%. This sharp decline in the prevalence of leprosy alongside the cessation of active surveillance for detection of leprosy cases has raised a sense of alarm in the scientific community. Material and methods: This is a total population survey aiming to estimate the prevalence of undetected active cases of leprosy in the community in defined rural (Panvel Taluka, Raigad District) and urban (M-East Ward, Mumbai) areas by health worker from Kushth Nivaran Samiti (Panvel) and Lok Seva Sangam (Mubai). Those provisionally diagnosed with leprosy were subjected to an independent verification using clinical, bacteriological and histopathological investigations at the Foundation for Medical Research. Findings: A population of 196,694 and 600,247 was covered in defined rural and urban areas respectively. In the rural area on examining 178,646 individuals, 120 provisionally diagnosed leprosy cases were detected, of which 65 were paucibacillary (PB) and 55 were multibacillary (MB) based on the WHO operational classification used by health worker at field level. In the urban area, of the 512,434 individuals who were examined, 134 provisionally diagnosed leprosy cases were detected with 92 PB and 42 MB cases. Among the clinically confirmed cases, 35-6% (32/90) and 34,9% (36/109) in rural and urban areas respectively were children. Conclusions: There are large numbers of undetected leprosy cases in the community with a high proportion of MB patients and children among them. This indicates active transmission pointing to the need for a paradigm shift in leprosy care services and control programme (AU)

Detection of previously undetected leprosy cases in a defined rural and urban area of Maharashtra, Western India.

INTRODUCTION: Leprosy has been a major public health problem in India for centuries. In India, between 2001 and 2005, the prevalence of leprosy was reduced by 80%. This sharp decline in the prevalence of leprosy alongside the cessation of active surveillance for detection of leprosy cases has raised a sense of alarm in the scientific community. MATERIALS AND METHODS: This is a total population survey aiming to estimate the prevalence of undetected active cases of leprosy in the community in defined rural (Panvel Taluka, Raigad District) and urban (M-East Ward, Mumbai) areas by health workers from Kushth Nivaran Samiti (Panvel) and Lok Seva Sangam (Mumbai). Those provisionally diagnosed with leprosy were subjected to an independent verification using clinical, bacteriological and histopathological investigations at the Foundation for Medical Research. FINDINGS: A population of 196,694 and 600,247 was covered in defined rural and urban areas respectively. In the rural area on examining 178,646 individuals, 120 provisionally diagnosed leprosy cases were detected, of which 65 were paucibacillary (PB) and 55 were multibacillary (MB) based on the WHO operational classification used by health workers at field level. In the urban area, of the 512,434 individuals who were examined, 134 provisionally diagnosed leprosy cases were detected with 92 PB and 42 MB cases. Among the clinically confirmed cases, 35.6% (32/90) and 34.9% (36/109) in rural and urban areas respectively were children. CONCLUSIONS: There are large numbers of undetected leprosy cases in the community with a high proportion of MB patients and children among them. This indicates active transmission pointing to the need for a paradigm shift in leprosy care services and control programme.

Sensitivity and specificity of nerve palpation, monofilament testing and voluntary muscle testing in detecting peripheral nerve abnormality, using nerve conduction studies as gold standard; a study in 357 patients.

OBJECTIVE: To determine sensitivity and specificity of clinical tools viz. nerve palpation (NP), monofilament (MF), and voluntary muscle testing (VMT), for assessing peripheral nerve function impairment (NFI) in leprosy, using nerve conduction studies (NCS) as gold standard. STUDY POPULATION AND METHODS: 357 untreated multibacillary (MB) leprosy patients were assessed using above tests. The nerves assessed were left and right ulnar, median, radial cutaneous, sural, common peroneal and posterior tibial. The concordance between the clinical and NCS tests was done for each nerve. The sensitivity and specificity of clinical tests for detecting nerve impairment was determined, using NCS as gold standard. Analysis was performed using SPSS version 10.0. RESULTS: The sensitivity of NP ranged between 71% to 88% for all nerves, except the median (43%) and sural (59%) nerves. Specificity was > 60% for all, but low for ulnar (34%) and common peroneal (40%) nerves. The specificity of MF testing was > 80% and of VMT assessment was >90% for all nerves. The sensitivity of MF testing ranged between 35-44%, while of VMT assessment was very low i.e. 4-5%, the maximum was for the ulnar nerve (25%). Detection sensitivity of MF testing and VMT assessment improved two fold when combined with NP and was closely comparable to NCS test findings. CONCLUSIONS: Both MF testing and VMT assessment showed good specificity, but moderate to low sensitivity. NP was less specific but more sensitive than MF testing and VMT assessment. Combining NP with MF testing and VMT assessment gives a two fold improvement in the sensitivity for assessing nerve damage and could therefore serve as the most useful clinical tools for diagnosis of leprosy and detecting nerve damage at field level.

The effect of corticosteroid usage on the bacterial killing, clearance and nerve damage in leprosy: a prospective cohort study: part 1--study design and baseline findings of 400 untreated multibacillary patients.

OBJECTIVE: To investigate possible adverse effects of therapeutic usage of corticosteroids on the killing and clearance of M. leprae and the clearance of granuloma, in patients with multibacillary (MB) leprosy. DESIGN: A cohort of 400 untreated MB patients were sub-grouped into those to be treated with corticosteroids (prednisolone 40 mg daily tapered to 5 mg over 12 weeks) along with MB-MDT for reaction and/or neuritis or silent neuropathy (SN) of <6 months duration (group A), and those with no reaction and to be treated with MDT only (group B). Clinical, bacteriological, histopathological and neurological test findings at fixed time points were compared. Analysis was performed using SPSS version 10.0. The significance of association was tested using Chi-square test. In the current report, we describe the study design and baseline findings of 400 untreated MB patients, with special emphasis on differences between patients in groups A and B. RESULTS: At baseline, applying Ridley-Jopling classification, 39% patients were BT, 20% BB, 24% BL, 12% sub-polar LL and 5% pure neural (PN). Overall, 60% patients were slit skin smear (SSS) negative and 33% presented with disability either grades 1 or 2. Overall 140/400 (35%) patients presented with reaction and/or neuritis and 11/400 (3%) presented with SN of <6 months duration. Comparing groups A and B, the percentage of patients presenting with DG2 was significantly higher in group A (43%). By clinical tests, monofilaments (MF) and voluntary muscle testing (VMT), the percentage of patients and nerves showing functional impairment was also significantly higher in group A. However, in the more sensitive nerve conduction velocity (NCV) test, the percentage of patients that showed nerve abnormalities was closely comparable; 94% and 91% in groups A and B respectively while number of affected nerves was higher in group A. CONCLUSION: At baseline, as recorded by NCV, peripheral nerve function abnormality was observed in almost all the MB patients regardless of reaction; but among those presenting with reaction or neuritis, the nerve damage was more severe and extensive.