Leprosy: Treatment and management of complications.

In the second article in this continuing medical education series, we review the treatment of leprosy, its immunologic reactions, and important concepts, including disease relapse and drug resistance. A fundamental understanding of the treatment options and management of neuropathic sequelae are essential to reduce disease burden and improve patients' quality of life.

Leprosy: Clinical aspects and diagnostic techniques.

Leprosy, also known as Hansen's disease, is a curable infectious disease that remains endemic in >140 countries around the world. Despite being declared "eliminated" as a global public health problem by the World Health Organization in the year 2000, approximately 200,000 new cases were reported worldwide in 2017. Widespread migration may bring leprosy to nonendemic areas, such as North America. In addition, there are areas in the United States where autochthonous (person-to-person) transmission of leprosy is being reported among Americans without a history of foreign exposure. In the first article in this continuing medical education series, we review leprosy epidemiology, transmission, classification, clinical features, and diagnostic challenges.

Dermlep Study Part 3: Post-RFT Events in Leprosy Patients Presenting to Dermatologists.

Introduction: Presently the leprosy program has no defined surveillance protocols for patients who complete the fixed duration multidrug therapy and are released from treatment (RFT). Hence, the information about the post-RFT events in these patients is sparse and qualitative and quantitative data regarding their health care requirements is missing. During the DermLep survey carried out by the Indian Association of Dermatologists,Venereologists and Leprologists (IADVL), a number of patients presented to dermatologists during the post RFT period for a variety of symptoms. This paper analyses the events in these patients during the post RFT period. Results: Out of a total of 3701 leprosy patients who presented to 201 dermatologists across India during the DermLep survey, 708 (26.2%) were in the post RFT period (488 males; 220 females). Of these, 21% were PB and 79% MB patients as per their treatment records. Majority were in the age group of 31-59 years (55.5%); however, a significant proportion of them (20.7%) were elderly (>60 years). Majority of the patients (45.5%) presented within the first year of RFT with variable symptoms; 28% were between 1-5 years, 5.5% between 5-10 years; and 11.0% presented more than 10 years after RFT. Most common presenting complaint being persistent skin lesions as perceived by patients in 21.2%, followed by neuritis in 14.5%; trophic ulcers in 13.8%; deformities in 67 (11.8%); lepra reactions in 66 (11.6%); and recurrence of original symptoms in 6.7%. Conclusion: The DermLep Survey highlights the importance of 'post RFT' patients as an important subset of leprosy patients who visit dermatologists for various health related issues. The most common complaints in this subset were active/persistent skin lesions, lepra reactions and neuritis. In these patients, who are a sub-group of 'persons affected with leprosy' the disease related issues can persist for many years post RFT. Hence, it is important to provide services in the programme to monitor and manage these complications for the prevention of impairments, disability and the related social issues.

Changes in the size and number of skin lesions in PB leprosy on treatment and follow-up.

BACKGROUND: The increase in size of existing skin lesions and appearance of new skin lesions are considered important signs of clinical activity both in untreated and treated leprosy. To confirm such activity, the number and size of lesions need to be recorded methodically prior to therapy and on follow-up, especially in PB leprosy where clinical signs alone define the reactivation of the disease. However, no systematic follow-up studies are available on changes in size and number of skin lesions in PB leprosy before and after therapy. OBJECTIVES: To measure changes in the number and size of skin lesions in PB leprosy patients before starting MDT PB and after 18 months follow-up in order to evaluate their relevance in assessing clinical improvement and identifying possible relapses. DESIGN: In 32 untreated leprosy patients with 1-5 skin lesions, the number of skin lesions were recorded on body charts and their size measured using a grid chart method to arrive at total area of involvement in each patient prior to starting MDT PB and after 18 months. Skin smears and skin biopsies were performed at entry and follow-up to assist the clinical evaluation. RESULTS: Twenty three patients had single skin lesion (SSL), followed by three each with two and three skin lesions respectively, two with four and one with five skin lesions. The area of involvement ranged from six to 1686 sq cm. Few patients with SSL had higher areas of involvement than those who had multiple skin lesions. On follow-up at 18 months, in 14 (44%) patients skin lesions were not measurable, while in 18 (56%) they were measurable, with eight (25%) patients showing no change, three (9%) showing decrease and seven (22%) showing increase in area of involvement. Of the seven patients showing increase, in three it was due to the spread of existing skin lesions alone, in one it was due to a new skin lesion alone and in three due to the spread of existing skin lesions and the appearance of new skin lesions. New skin lesions were multiple (> 3) in two patients. T1R was observed in three out of four patients with new skin lesions, and this was persistent at 18 months in one patient. When histopathology at the entry and 18 month follow-up was compared, in one patient with persistent T1R with appearance of multiple new skin lesions, there was increase in GF from 10 to 40% with histological features of T1R and a BI of granuloma of 1+. CONCLUSIONS: In 32 treated patients of PB leprosy on 18 month follow-up for changes in size and number of skin lesions, of six patients showing increase in area of involvement of existing skin lesions, 3 (50%) developed new skin lesions, indicating persistent disease activity. The new lesions which were associated with T1R increased the total number of skin lesions to > 5 in two of these patients requiring a change of drug regimen from PB to MB MDT, with one of them fulfilling clinical and histopathological criteria for relapse of leprosy. Hence, although new lesions are known to occur as part of T1R in PB patients, they are events of great significance which need to be assessed in a methodical manner for their influence on classification and therapy of leprosy.

Updates on Management of Leprosy in the Context of COVID-19 Pandemic: Recommendations by IADVL SIG Leprosy.

The Special Interest Group (SIG) on leprosy thought it to be prudent to revisit its previous practice recommendations through this update. During this period, the pandemic course shifted to a 'second wave' riding on the 'delta variant'. While the number of cases increased manifold, so did the research on all aspects of the disease. Introduction of vaccination and data from various drug trials have an impact on current best practices on management of diseases including leprosy. The beneficial results of using steroids in management of COVID-19, gives elbow room regarding its usage in conditions like lepra reactions. On the other hand, the increase in cases of Mucormycosis again underlines applying due caution while recommending immunosuppressants to a patient already suffering from COVID-19. This recommendation update from SIG leprosy reflects current understanding about managing leprosy while the dynamic pandemic continues with its ebbs and flows.

Etiological prevalence and antifungal sensitivity patterns of dermatophytosis in India - A multicentric study.

BACKGROUND: The prevalence of dermatophytes varies with season, geographical area, socio-economic factors and effective management strategies. AIMS: The aim of the study was to assess the prevalence of pathogenic dermatophytes, clinical types of dermatophyte fungal infection, and in vitro antifungal drug susceptibility testing against dermatophytes. METHODS: Three hundred and ninety five patients with dermatophytosis were enrolled from five cities (Mumbai, Delhi, Lucknow, Kolkata and Hyderabad) across India. All patients were subjected to clinical examination and investigations, including potassium hydroxide microscopy, fungal culture and antifungal drug susceptibility testing. RESULTS: Trichophyton rubrum was the most common species identified (68.4%), followed by T. mentagrophytes (29.3%). Within species, T. mentagrophytes was prevalent in humid environmental conditions (Mumbai and Kolkata), whereas T. rubrum was prevalent in noncoastal areas (Delhi, Lucknow and Hyderabad). Tinea corporis (71.4%) and tinea cruris (62.0%) were the common clinical types observed. antifungal drug susceptibility testing data indicated that minimum inhibitory concentration required to inhibit the growth of 90% of organisms (MIC-90) was lowest for griseofulvin (0.25-3.0 µg/mL). Among oral antifungals, the mean MIC of itraconazole was within the range (0.84 [0.252] µg/ mL), whereas high mean MIC values were reported for terbinafine (0.05 [0.043] µg/mL). Among topical agents, lowest mean MIC values were reported for luliconazole (0.29 [0.286] µg/mL), eberconazole (0.32 [0.251]) µg/mL and amorolfine (0.60 [0.306]) µg/mL. LIMITATIONS: Lack of correlation between in vitro antifungal susceptibility and clinical outcome and absence of defined MIC breakpoints. CONCLUSION: T. rubrum was the most common, followed by T. mentagrophytes as an emerging/codominant fungal isolate in India. Tinea corporis was the most common clinical type of dermatophytosis. Mean MIC of terbinafine was above the reference range, while it was within the range for itraconazole; griseofulvin had the lowest mean MIC. Luliconazole presented the lowest mean MIC values across cities.

The Dermlep Study Part 2: Results of a Nation-Wide Survey of Dermatologists' Access to Quality Leprosy Services at their Clinics and Hospitals in India.

INTRODUCTION: Dermatologists in India are trained and qualified to treat leprosy and there is evidence to suggest that they are involved in the diagnosis and management of a significant number of leprosy patients in the country. The present study evaluated the access to quality leprosy services at their clinics and hospitals to understand the extent of their role in providing comprehensive care to people affected by leprosy and how it can be organized further. METHODS: The DermLep Study was a pan-India questionnaire-based survey carried out to evaluate the role that dermatologists play in leprosy management in the country. It included as part-2 of the survey, 11 questions on the access of the dermatologist to various quality leprosy services available at the clinic or institution including skin smears, skin biopsy, multidrug therapy (MDT) blister packs, basic physiotherapy services, and reporting to the national program (NLEP). RESULTS: The dermatologists who participated in the survey included 101 private practitioners and 100 working in Government or private medical institutions. The key findings of the survey were that 78% of the participating dermatologists still encounter leprosy patients frequently in their clinics; 81.0% of them had access to skin smears; and 93.4% to skin biopsy. The World Health Organization (WHO) MDT regimen was followed by 79.0% of the dermatologists in the study, majority of whom were those working in medical colleges (88%); however overall, 87.4% extended the regimen beyond the fixed duration, mostly on a case to case basis. Thalidomide was available for 61.1% of them to treat type 2 reactions. Basic physiotherapy services were available with 70.2% of dermatologists surveyed; 58.9% dermatologists had access to MCR footwear; and RCS facility access known to 45.5% of them. About 83.5% of the dermatologists working in institutions were reporting their leprosy cases to the NLEP, whereas from a high percentage (71.4%) of dermatologists in private practice, cases were not captured in routine under NLEP. CONCLUSION: Dermatologists in India have the clinical skill, expertise, and access to most of the basic services, including skin smear and skin biopsy facilities needed to provide comprehensive care to leprosy patients in post-elimination era of integration of leprosy services. While dermatologists are already managing leprosy patients both at medical institutes and private clinics across India, their "structured" involvement at all levels in the national program will facilitate improved reporting and cataloging of cases seen by them. It will also elevate standards of leprosy care; create an effective public-private partnership and disease expertise; and assist develop a comprehensive, patient-tailored approach in the leprosy program in India.

The DermLep Study I: Results of Prospective Nation-Wide Survey of the Number & Profile of Leprosy Patients seen by Dermatologists in India.

INTRODUCTION: There is evidence to suggest that there is a mismatch between the number of reported cases of leprosy in India and the number of actual cases in the country. One reason could be that many patients are diagnosed and treated outside the NLEP network and dermatologists may be managing some of these patients not captured by official statistics. To estimate these missing numbers, the DermLep survey was carried out to study the number and profile of leprosy patients seen by dermatologists and their significance. METHODOLOGY: The DermLep survey was a questionnaire-based study to be filled in by participating dermatologists from all over India, both in private practice and in medical institutions. Participating dermatologists provided information on old and new leprosy patients seen in their clinic over a 3-month period. RESULTS: Total of 201 dermatologists from 20 states of India participated in the survey. 3701 leprosy patients (M: F ratio 2.1:1) were seen. Of them 46.62% (n = 1680) were new; 22.89% (n = 825) were under-treatment; and 19.65% (n = 708) were post RFT patients. Children <15 years constituted 4.29%, while elderly >60 years were 22.21%. As per WHO classification, MB were 73.36% and PB 28.46%. Of all patients 30.91% had lepra reactions, with T2R being more frequent. While 23.58% of all patients in the survey had G2D; in new patients 17.79%; and in post RFT patients 37% had G2D. Among the 1680 new cases seen, 59% were reported to NLEP by the dermatologists and 41% remained unreported mainly by the private dermatologists, among whom for 20% of the cases they mentioned "no access to register". Source of MDT was WHO-MDT in 60.09% of new cases and for rest of 39.91% it was private pharmacies where private dermatologists had no access to MDT blister packs. CONCLUSION: This survey suggests that a good number of new-untreated leprosy patients, treatment defaulters and post RFT cases are managed by dermatologists in India. About 40% of the new patients managed mainly by private dermatologists are not being reported to NLEP for various reasons, and these constitute the "missing numbers" from government statistics. If extrapolated to the large of number of practicing dermatologists in India, these numbers could be very significant. The high percentage of G2D noted in patients surveyed (23.58%) and post RFT patient issues observed need special attention. There is a need to develop access for dermatologists to confidentially report leprosy patients treated at their clinics to the NLEP.

Indian Association of Dermatologists, Venereologists and Leprologists (IADVL) Task Force against Recalcitrant Tinea (ITART) Consensus on the Management of Glabrous Tinea (INTACT).

BACKGROUND AND AIMS: Dermatophytosis has always been a common superficial mycosis in India. However, the past 6-7 years have seen an unprecedented increase in the number of patients affected by recurrent, chronic, recalcitrant and steroid modified dermatophytosis involving the glabrous skin (tinea corporis, tinea cruris and tinea faciei). Importantly, there has been a notable decrease in clinical responsiveness to commonly used antifungals given in conventional doses and durations resulting in difficult-to-treat infections. Considering that scientific data on the management of the current epidemic of dermatophytosis in India are inadequate, the Indian Association of Dermatologists, Venereologists and Leprologists (IADVL) Task force Against Recalcitrant Tinea (ITART) has formulated a consensus statement on the management of dermatophytosis in India. METHODS: Seventeen dermatologists with a focussed interest in dermatophytosis participated in a Delphi consensus method, conducted in three rounds. They responded as either "agree" or "disagree" to 132 statements prepared by the lead experts and gave their comments. Consensus was defined as an agreement of 80% or higher concurrence. Statements on which there was no consensus were modified based on the comments and were then recirculated. The results were finally analysed in a face-to-face meeting and the responses were further evaluated. A draft of the consensus was circulated among the participants and modified based on their inputs. RESULTS: Consensus was achieved on 90 of the 132 statements. Direct microscopy using potassium hydroxide mount was recommended in case of diagnostic difficulty on clinical examination. Counselling of patients about strict adherence to general measures and compliance to treatment was strongly recommended as the key to successful management of dermatophytosis. A combination of systemic and topical antifungal drugs was recommended for the treatment of glabrous tinea in the current scenario. Topical corticosteroid use, whether used alone or in combination with other components, was strongly discouraged by all the experts. It was suggested that topical antifungals may be continued for 2 weeks beyond clinical resolution. Itraconazole and terbinafine were recommended to be used as the first line options in systemic therapy, whereas griseofulvin and fluconazole are alternatives. Terbinafine was agreed to be used as a first line systemic agent in treatment naïve and terbinafine naïve patients with glabrous tinea. Regular follow-up of patients to ensure compliance and monitoring of clinical response was recommended by the experts, both during treatment and for at least 4 weeks after apparent clinical cure. Longer duration of treatment was recommended for patients with chronic, recurrent and steroid modified dermatophytosis. CONCLUSION: Consensus in the management of dermatophytosis is necessary in the face of conventional regimens proving ineffective and dearth of clinical trials re-evaluating the role of available antifungals in the wake of evolving epidemiology of the infection in the country. It needs to be backed by more research to provide the required level of evidence. It is hoped that this consensus statement improves the quality of care for patients with dermatophytosis, which has emerged as a huge public health problem, imposing considerable financial burden on the country.

Comparative study of uniform-MDT and WHO MDT in Pauci and Multi bacillary leprosy patients over 24 months of observation.

STUDY DESIGN: An open comparative study between WHO MDT and U-MDT regimen in all types of leprosy over 24 months of observation was carried out at Gandhi Hospital, Secunderabad, India. Periodic assessment of clinical and histopathological parameters at 6 monthly intervals was performed in both groups of patients for grading response to the treatment regimens. PATIENTS AND METHODS: One hundred and twenty-seven newly diagnosed, untreated leprosy patients classified into PB (< or = 5 skin lesions) and MB leprosy (> 5 skin lesions) were alternately allocated into Study (U-MDT for 6 months) and Control groups (WHO MDT) at entry. Out of the 127 patients included, 64 patients (M-44, F-20; PB leprosy 32 & MB leprosy 32) could be followed-up regularly. These 64 patients were clinically assessed and graded into Good, Moderate and Poor response at 6, 12 and 18 months of the study, and 44 of these patients were also assessed at 24 months of the study. Histopathological assessments were also done at the above intervals. RESULTS: PB PATIENTS: The control and study groups comprised of 14 and 18 patients respectively. When clinical grades were compared, the numbers of Moderate and Good responses were 78% and 61% at 6 months, 86% and 94% at 18 months and 82% and 100% at 24 months in the PB Control and Study groups respectively, suggesting better progressive improvement in the Study group compared to Control group, but the differences were not significant (At 6 months P = 02195, at 18 months 0.7305, at 24 months P = 0.3500) Histopathological assessment at 12 months, showed higher percentage of Good responses (100%) in the PB-Study group than in the PB-Control group (86%). MB PATIENTS: The MB Control and Study groups comprised of 22 and 10 patients respectively. In clinical improvement grades, Good responses in the Control group was 36%, 45% and 77% at 12, 18 and 24 months of study, whereas the Study group did not have a single Good response at 12 and 18 months with the Poor responses being 50%, 67% and 75% at 12, 18 and 24 months. These differences between the groups were significant at all periods of assessment. (At 12 months P = 0.0465, at 18 months P = 0.0014, at 24 months P = 0.0064). Histopathological assessment showed higher the percentage of Good responses in Control group (100%) compared to Study group (50%) at 18 months. CONCLUSION: U-MDT of 6 months duration was well tolerated and effective in patients with PB leprosy but was too short a regimen adequately to treat patients with MB leprosy.

Current Situation of Leprosy in India and its Future Implications.

The global leprosy situation has changed significantly over the last four decades after the introduction of multidrug therapy (MDT) in 1982 with a reduction in prevalence from over 5 million cases in the mid-1980s to less than 200,000 at the end of 2016. The programme in India also saw a reduction from a prevalence rate of 57.8/10,000 in 1983 to less than 1/10,000 by the end of 2005 when India declared to have reached the World Health Organization (WHO) target of elimination as a public health problem. Post 2005, major changes in the programme were made by the National leprosy eradication programme (NLEP) and the global leprosy programme, which may have affected the new case detection (NCD), disability, and child leprosy trends, which continue to show no appreciable regression. This article reviews the current global and Indian leprosy scenario to bring out its achievements and successes, including the impact of Leprosy Case Detection Campaigns (LCDC) on leprosy numbers. The basis and expected benefits of recent introduction of chemo and immune-prophylaxis in the programme are also discussed. It also discusses the shortcomings, the areas of concern, and the need for an inclusive strategy in the Indian leprosy programme that includes an intersectoral collaboration within the country for reaching the desired goal of leprosy eradication.

Evaluation of leprosy patients with 1 to 5 skin lesions with relevance to their grouping into paucibacillary or multibacillary disease.

BACKGROUND: Patients with 1 to 5 skin lesions are arbitrarily categorized as belonging to the paucibacillary (PB) group for treatment purposes. With the decreasing prevalence of leprosy in India and modifications in leprosy program, the relevance of this grouping needs further study. AIMS: To study a group of leprosy patients with 1 to 5 skin lesions and compare the clinical parameters with histopathological findings and bacteriological status of the skin and nerve to evaluate the relevance of this grouping. METHODS: Seventy seven patients of leprosy with 1 to 5 skin lesions were included in the study. The number of skin lesions was recorded. Slit skin smears (SSS) and skin biopsies were taken in all patients and nerve biopsy was performed in 19 of them. The biopsies were evaluated for the type of pathology and AFB status. RESULTS: In these 77 patients (single skin lesions, 42; two lesions, 18; three lesions, 10; four lesions, 5; and five lesions, 2 patients) the clinical classification was indeterminate leprosy (IL) in 4, tuberculoid leprosy (TT) in 4 patients and borderline tuberculoid leprosy (BT) in 69 patients. Skin smears were positive only in 1 patient. The histological diagnoses in the skin were IL in 13, TT in 3, BT in 48 and borderline lepromatous (BL) in 4 patients. Acid-fast bacilli (AFB) were found in 14 out of 77 skin biopsies. Of the 19 nerve biopsies, 17 showed histological features of BT leprosy; of these, 12 demonstrated AFB on Fite staining. The bacillary index of granuloma (BIG) ranged from 1+ to 2+. The clinico-histopathogical correlation was 63% in the BT group, with 4 patients of this group showing features of BL on histopathology. When the presence of AFB was assessed, the percentage of positivity was 1.3% in SSS, 18% in skin biopsies and 63% in nerve biopsies. CONCLUSION: Our results point to the non-homogeneous nature of this group of leprosy patients with 1 to 5 skin lesions, with varied bacteriological and histopathological features. The significance of MB type findings on histopathology in patients grouped as PB leprosy should be resolved so that these patients may be given the drug therapy and the duration of therapy they warrant.

Pure neuritic leprosy: Current status and relevance.

Pure neuritic leprosy has always been an enigma due to its clinical and management ambiguities. Although only the Indian Association of Leprologist's classification recognizes 'pure neuritic leprosy' as a distinct sub group of leprosy, cases nonetheless are reported from various countries of Asia, Africa, South America and Europe, indicating its global relevance. It is important to maintain pure neuritic leprosy as a subgroup as it constitutes a good percentage of leprosy cases reported from India, which contributes to more than half of global leprosy numbers. Unfortunately, a high proportion of these patients present with Grade 2 disability at the time of initial reporting itself due to the early nerve involvement. Although skin lesions are absent by definition, when skin biopsies were performed from the skin along the distribution of the affected nerve, a proportion of patients demonstrated leprosy pathology, revealing sub-clinical skin involvement. In addition on follow-up, skin lesions are noted to develop in up to 20% of pure neuritic leprosy cases, indicating its progression to manifest cutaneous disease. Over the decades, the confirmation of diagnosis of pure neuritic leprosy has been subjective, however, with the arrival and use of high-resolution ultrasonography (HRUS) for nerve imaging, we have a tool not only to objectively measure and record the nerve thickening but also to assess the morphological alterations in the nerve including echo texture, fascicular pattern and vascularity. Management of pure neuritic leprosy requires multidrug therapy along with appropriate dose of systemic corticosteroids, for both acute and silent neuritis. Measures for pain relief, self-care of limbs and physiotherapy are important to prevent as well as manage disabilities in this group of patients.

SAPHO syndrome with acne fulminans and severe polyosteitis involving axial skeleton.

SAPHO syndrome (synovitis, acne, pustulosis, hyperostosis, osteitis), a rare inflammatory disorder, is an association of distinct skin disorders with pustules with osteoarticular inflammation. Its etiology remains unclear, and various treatment regimens frequently fail to control the disease. An 18-year-old male patient presented to the outpatient department with severe nodulocystic acne on the face with pain at both the wrists and lower back associated with high-grade fever and chills. On physical examination, he had severe tenderness at both wrist joints and lower back, along with swelling of right wrist. Magnetic resonance imaging revealed osteitis of the distal end of the right radius. Technetium-99m-MDP Whole Body Bone Scan revealed increased metaphyseal uptake in distal radius on both sides and prominent uptake at the sacroiliac joints, vertebral end plate, left 7th costo-vertebral joint and bilateral sternoclavicular joints and manubrium sternum (resulting in "bull's head" sign, which is characteristic of SAPHO syndrome). He responded very well to a combination therapy of nonsteroid anti-inflammatory drugs, antibiotics, colchicine, and isotretinoin over a 12-week period.

Comparison of two systems of classification of leprosy based on number of skin lesions and number of body areas involved--a clinicopathological concordance study.

BACKGROUND AND AIMS: WHO guidelines classify leprosy patients for therapeutic purposes into paucibacillary (PB) and multibacillary (MB) leprosy based on the number of skin lesions. An alternative system of classification has been in practice in Nepal from 1985 onwards, based on the number of body areas involved in patients of leprosy. We attempted a clinicopathological approach for comparison of these two systems of classification in leprosy patients for their ability to demarcate patients into groups of PB and MB leprosy. MATERIALS AND METHODS: The study included 108 leprosy patients (80 males and 28 females). Complete clinical examination and body charting was carried out in each patient noting the count of skin lesions and the number of body areas involved. Slit skin smears and skin biopsies were taken from an active skin lesion in all patients. RESULTS: On analysis, it was observed that there was good clinicopathological correlation between patients with 5 or < 5 skin lesions and 2 or < 2 body areas involved. (Clinical 95% and histological 96%) A similar correlation was also observed in the other group of patients with > 5 skin lesions and > 2 body areas involved, (Clinical 94% and histological 96%). There were almost identical numbers of patients represented in these two groups of classification. CONCLUSIONS: Our findings suggest that patients with involvement of 2 or less body areas can be classified as PB leprosy and those with more than 2 body areas involved can be classified as MB leprosy for the purposes of therapy. The study of areas of involvement in leprosy patients not only provides additional patient information but also adds another parameter as a basis for the study of leprosy patients.