Late relapses in leprosy patients in Brazil: 10-year post-trial of uniform multidrug therapy (U-MDT/CT-BR).

BACKGROUND: Leprosy is a neglected dermato-neurologic, infectious disease caused by Mycobacterium leprae or M. lepromatosis. Leprosy is treatable and curable by multidrug therapy/MDT, consisting of 12 months rifampicin, dapsone and clofazimine for multibacillary/MB patients and for 6 months for paucibacillary/PB patients. The relapse rate is considered a crucial treatment outcome. A randomized Controlled Trial (U-MDT/CT-BR) conducted from 2007‒2012 compared clinical outcomes in MB patients after 12 months regular MDT/R-MDT and 6 months uniform MDT/U-MDT in two highly endemic Brazilian areas. OBJECTIVES: To estimate the 10 years relapse rate of MB patients treated with 6 months U-MDT. METHODS: The statistical analyses treated the data as a case-control study, sampled from the cohort generated for the randomized trial. Analyses estimated univariate odds ratio and applied logistic regression for multivariate analysis, controlling the confounding variables. RESULTS: The overall relapse rate was 4.08 %: 4.95 % (16 out of 323) in the U-MDT group and 3.10 % (9 out of 290) in the regular/R-MDT group. The difference in relapse proportion between U-MDT and R-MDT groups was 1.85 %, not statistically significant (Odds Ratio = 1.63, 95 % CI 0.71 to 3.74). However, misdiagnosis of relapses, may have introduced bias, underestimating the force of the association represented by the odds ratio. CONCLUSIONS: The relapse estimate of 10 years follow-up study of the first randomized, controlled study on U-MDT/CT-BR was similar to the R-MDT group supporting strong evidence that 6 months U-MDT for MB patients is an acceptable option to be adopted by leprosy endemic countries worldwide. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00669643.

Epidemiological profile of rosacea in dermatology outpatient clinics in Brazil: an observational report from the Brazilian study group on rosacea.

BACKGROUND: Rosacea prevalence varies worldwide and there is a lack of information in Brazil. OBJECTIVES: To describe the epidemiological profile of rosacea in subjects who consulted in dermatological outpatient clinics in Brazil. MATERIALS & METHODS: A cross-sectional study was conducted in 13 dermatological outpatient clinics across the country. Patients with rosacea diagnosis were eligible for the study according to the investigator's clinical assessment. Clinical, social and demographic data were collected. The overall and regional rosacea prevalence was calculated, and association with baseline characteristics was analysed. RESULTS: A total of 3,184 subjects were enrolled, and rosacea prevalence was 12.7%. The southern region of Brazil presented a higher prevalence, followed by the southeast. The subjects in the rosacea group were older than those without rosacea (52.5 ±14.9 vs. 47.5 ±17.5; p<0.001). Moreover, the rosacea group was associated with Fitzpatrick's phototypes I and II, Caucasian ethnicity, a family history of rosacea, and facial erythema, however, no association with gender was found. The most prevalent clinical sign and clinical subtype in rosacea patients were erythema and erythematotelangiectatic, respectively. CONCLUSION: Rosacea is highly prevalent in Brazil, mostly in the southern region, associated with phototypes I and II and a family history.

National Health Survey reveals high percentage of signs and symptoms of leprosy in Brazil. / Pesquisa Nacional de Saúde revela alto percentual de sinais e sintomas de hanseníase no Brasil.

Leprosy is a debilitating, infectious, systemic or localized dermato-neurological disease caused by Mycobacterium lepra. In Brazil, the magnitude and high disabling power keep the disease as a public health problem. Skin spotting and numbness are pathognomonic signs and symptoms in leprosy. The Instituto Brasileiro de Geografia e Estatística (IBGE) 2019 National Health Survey (PNS-2019) considered the following question as a proxy to estimate its magnitude in the country. "Do you have a spot with numbness or part of the skin with numbness?". In Brazil, 1,921,289 adults reported having a patch or part of the skin with numbness, with no regional differences. As for the age group, the older, the higher the prevalence, for example, between 18 to 29 years old (235,445) and 30 to 39 years old (236,485), 0.7% had the condition, between 40 to 59 years old (827,887), 1.5% and among the elderly, 1.8% (621,472). Being able to estimate, in population-based surveys, with statistical representativeness, a reported morbidity such as leprosy is essential to support the formulation of public policies, notably those related to primary health care actions. In this way, the IBGE fulfills its constitutional role of portraying the reality of the Brazilian population and today it is the main external evaluator of the Unified Health System (SUS) and of public policies developed by the federal level.

A hanseníase é uma doença dermato-neurológica, infecciosa, sistêmica ou localizada, debilitante, causada por Mycobacterium leprae. No Brasil, a magnitude e o alto poder incapacitante mantêm a doença como um problema de saúde pública. Mancha na pele e dormência são sinais e sintomas patognomônicos na hanseníase. A Pesquisa Nacional de Saúde de 2019 (PNS-2019), do Instituto Brasileiro de Geografia e Estatística (IBGE), considerou a seguinte pergunta como proxy para estimar sua magnitude no país. "O(a) sr(a). tem mancha com dormência ou parte da pele com dormência?". No Brasil, 1.921.289 adultos referiram ter mancha ou parte da pele com dormência, sem diferenças regionais. Com relação ao grupo etário, quanto mais velho, maior a prevalência. Por exemplo, entre os de 18 a 29 anos (235.445) e de 30 a 39 anos (236.485), 0,7% possuía a condição, entre 40 e 59 anos (827.887), 1,5%, e entre os idosos, 1,8% (621.472). Poder estimar, em pesquisas de base populacional, com representatividade estatística, uma morbidade referida tal como a hanseníase é fundamental para apoiar a formulação de políticas públicas, notadamente as relativas às ações da atenção primária à saúde. Dessa forma, o IBGE cumpre seu papel constitucional de retratar a realidade da população brasileira e hoje é o principal avaliador externo do Sistema Único de Saúde (SUS) e das políticas públicas instituídas no âmbito federal.

Pesquisa Nacional de Saúde revela alto percentual de sinais e sintomas de hanseníase no Brasil / National Health Survey reveals high percentage of signs and symptoms of leprosy in Brazil

Resumo A hanseníase é uma doença dermato-neurológica, infecciosa, sistêmica ou localizada, debilitante, causada por Mycobacterium leprae. No Brasil, a magnitude e o alto poder incapacitante mantêm a doença como um problema de saúde pública. Mancha na pele e dormência são sinais e sintomas patognomônicos na hanseníase. A Pesquisa Nacional de Saúde de 2019 (PNS-2019), do Instituto Brasileiro de Geografia e Estatística (IBGE), considerou a seguinte pergunta como proxy para estimar sua magnitude no país. "O(a) sr(a). tem mancha com dormência ou parte da pele com dormência?". No Brasil, 1.921.289 adultos referiram ter mancha ou parte da pele com dormência, sem diferenças regionais. Com relação ao grupo etário, quanto mais velho, maior a prevalência. Por exemplo, entre os de 18 a 29 anos (235.445) e de 30 a 39 anos (236.485), 0,7% possuía a condição, entre 40 e 59 anos (827.887), 1,5%, e entre os idosos, 1,8% (621.472). Poder estimar, em pesquisas de base populacional, com representatividade estatística, uma morbidade referida tal como a hanseníase é fundamental para apoiar a formulação de políticas públicas, notadamente as relativas às ações da atenção primária à saúde. Dessa forma, o IBGE cumpre seu papel constitucional de retratar a realidade da população brasileira e hoje é o principal avaliador externo do Sistema Único de Saúde (SUS) e das políticas públicas instituídas no âmbito federal.

Abstract Leprosy is a debilitating, infectious, systemic or localized dermato-neurological disease caused by Mycobacterium lepra. In Brazil, the magnitude and high disabling power keep the disease as a public health problem. Skin spotting and numbness are pathognomonic signs and symptoms in leprosy. The Instituto Brasileiro de Geografia e Estatística (IBGE) 2019 National Health Survey (PNS-2019) considered the following question as a proxy to estimate its magnitude in the country. "Do you have a spot with numbness or part of the skin with numbness?". In Brazil, 1,921,289 adults reported having a patch or part of the skin with numbness, with no regional differences. As for the age group, the older, the higher the prevalence, for example, between 18 to 29 years old (235,445) and 30 to 39 years old (236,485), 0.7% had the condition, between 40 to 59 years old (827,887), 1.5% and among the elderly, 1.8% (621,472). Being able to estimate, in population-based surveys, with statistical representativeness, a reported morbidity such as leprosy is essential to support the formulation of public policies, notably those related to primary health care actions. In this way, the IBGE fulfills its constitutional role of portraying the reality of the Brazilian population and today it is the main external evaluator of the Unified Health System (SUS) and of public policies developed by the federal level.

Lucius phenomenon: the importance of a primary dermatological care

Abstract Leprosy presents a varied clinical spectrum. Lucius phenomenon is a rare leprosy reaction characterized by erythematous, painful, slightly infiltrated macules and hemorrhagic bullae that progress to ulceration. This case report describes a patient whose diagnosis of leprosy occurred in the presence of Lucius phenomenon. Late diagnosis and delay in the implementation of specific therapy contributed to an unfavorable outcome, highlighting the importance of early identification and treatment of this disease, as well as its complications.

A social network approach for the study of leprosy transmission beyond the household.

BACKGROUND: Mycobacterium leprae was the first microorganism directly associated with a disease, however, there are still important gaps in our understanding of transmission. Although household contacts are prioritized, there is evidence of the importance of extrahousehold contacts. The goal of this article is to contribute to our understanding of the transmission of leprosy ex-household. METHODS: We compare co-location data of 397 leprosy cases and 211 controls drawn from the Centro de Dermatologia Sanitária D. Libânia in Fortaleza, Brazil. We collected lifetime geolocation data related to residence, school attendance and workplace and developed novel methods to establish a critical distance (Rc) for exposure and evaluated the potential for transmission for residence, school and workplace. RESULTS: Our methods provide different threshold values of distance for residence, school and workplace. Residence networks demonstrate an Rc of about 500 m. Cases cluster in workplaces as well. Schools do not cluster cases. CONCLUSIONS: Our novel network approach offers a promising opportunity to explore leprosy transmission. Our networks confirm the importance of coresidence, provide a boundary and suggest a role for transmission in workplaces. Schools, on the other hand, do not demonstrate a clustering of cases. Our findings may have programmatic relevance.

Lucius phenomenon: the importance of a primary dermatological care.

Leprosy presents a varied clinical spectrum. Lucius phenomenon is a rare leprosy reaction characterized by erythematous, painful, slightly infiltrated macules and hemorrhagic bullae that progress to ulceration. This case report describes a patient whose diagnosis of leprosy occurred in the presence of Lucius phenomenon. Late diagnosis and delay in the implementation of specific therapy contributed to an unfavorable outcome, highlighting the importance of early identification and treatment of this disease, as well as its complications.

Prevalence of Metabolic Syndrome Among Patients with Psoriasis Treated with TNF Inhibitors and the Effects of Anti-TNF Therapy on Their Lipid Profile: A Prospective Cohort Study.

Background: Tumor necrosis factor (TNF) is an important inflammatory cytokine in the pathogenesis of psoriasis and metabolic syndrome (MS). Patients with psoriasis have higher rates of MS; therefore, some authors suggest an MS screening within this population. In addition, TNF inhibitor treatment often modifies the metabolic profiles of these patients. This study describes the epidemiological, clinical, and laboratory characteristics of patients with psoriasis undergoing anti-TNF treatment and evaluates whether anti-TNF treatments influence changes in their metabolic parameters. Methods: A prospective 6-month cohort study followed patients who underwent three consecutive consultations at 0, 3, and 6 months. The sample composed of 83 patients with psoriasis using anti-TNF. Results: The mean age and disease duration of the patients were 48 ± 11 and 16 ± 9 years, respectively. Most patients were men (61.5%). The prevalence of MS was 36%, and high rates of abdominal obesity (59%) and overweight (82%) were observed. Anti-TNF treatment significantly altered total cholesterol levels (195.5 ± 36.17 vs. 183.5 ± 41.23, P = 0.04) and low-density lipoprotein (LDL) cholesterol levels (128.5 ± 31.26 vs. 113 ± 36.31, P = 0.04). This study has some limitations, such as small sample size, brief follow-up period (6 months), patient recruitment from a tertiary-level referral center, and no control group. Conclusions: Patients with psoriasis have high rates of MS, overweight, and obesity, but anti-TNF treatment seems to improve the metabolic profile of these patients by decreasing their total and LDL cholesterol levels.

Clinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): adverse effects approach.

BACKGROUND: The Clinical Trial for Uniform Multidrug Therapy for Leprosy Patients in Brazil (U-MDT/CT-BR), designed to evaluate the effectiveness of a six-months regimen, assessed the adverse effects caused by the drugs. OBJECTIVE: Describe adverse effects due to MDT in U-MDT/CT-BR, comparing the uniform regimen (U-MDT) to the current WHO regimen (R-MDT). PATIENTS AND METHODS: After operational classification, patients were randomly allocated to the study groups. U-MDT PB and U-MDT MB groups, received the U-MDT regimen, six doses of MB-MDT (rifampicin, dapsone and clofazimine). R-MDT PB and R-MDT MB groups, received the WHO regimens: six doses (rifampicin and dapsone) for PB and 12 doses (rifampicin, dapsone and clofazimine) for MB. During treatment, patients returned monthly for clinical and laboratorial evaluation. Patients with single lesion were not included in this trial. RESULTS: Skin pigmentation (21.7%) and xerosis (16.9%) were the most frequent complaints among 753 patients. Laboratory exams showed hemoglobin concentration lower than 10g/dL in 23.3% of the patients, glutamic oxaloacetic transaminase (GOT) above 40U/L in 29.5% and glutamic pyruvic transaminase (GPT) above 40U/L in 28.5%. Twenty-four patients (3.2%) stopped dapsone intake due to adverse effects, of whom 16.6% due to severe anemia. One case of sulfone syndrome was reported. STUDY LIMITATIONS: Loss of some monthly laboratory sample collection. CONCLUSIONS: There was no statistical difference regarding adverse effects in the R-MDT and U-MDT groups but anemia was greater in patients from R-MDT/MB group, therefore adverse effects do not represent a constraint to recommend the six-month uniform regimen of treatment for all leprosy patients.

Clinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): adverse effects approach

Abstract: BACKGROUND: The Clinical Trial for Uniform Multidrug Therapy for Leprosy Patients in Brazil (U-MDT/CT-BR), designed to evaluate the effectiveness of a six-months regimen, assessed the adverse effects caused by the drugs. OBJECTIVE: Describe adverse effects due to MDT in U-MDT/CT-BR, comparing the uniform regimen (U-MDT) to the current WHO regimen (R-MDT). Patients and methods: After operational classification, patients were randomly allocated to the study groups. U-MDT PB and U-MDT MB groups, received the U-MDT regimen, six doses of MB-MDT (rifampicin, dapsone and clofazimine). R-MDT PB and R-MDT MB groups, received the WHO regimens: six doses (rifampicin and dapsone) for PB and 12 doses (rifampicin, dapsone and clofazimine) for MB. During treatment, patients returned monthly for clinical and laboratorial evaluation. Patients with single lesion were not included in this trial. RESULTS: Skin pigmentation (21.7%) and xerosis (16.9%) were the most frequent complaints among 753 patients. Laboratory exams showed hemoglobin concentration lower than 10g/dL in 23.3% of the patients, glutamic oxaloacetic transaminase (GOT) above 40U/L in 29.5% and glutamic pyruvic transaminase (GPT) above 40U/L in 28.5%. Twenty-four patients (3.2%) stopped dapsone intake due to adverse effects, of whom 16.6% due to severe anemia. One case of sulfone syndrome was reported. STUDY LIMITATIONS: Loss of some monthly laboratory sample collection. CONCLUSIONS: There was no statistical difference regarding adverse effects in the R-MDT and U-MDT groups but anemia was greater in patients from R-MDT/MB group, therefore adverse effects do not represent a constraint to recommend the six-month uniform regimen of treatment for all leprosy patients.

Evaluation of 16S rRNA qPCR for detection of Mycobacterium leprae DNA in nasal secretion and skin biopsy samples from multibacillary and paucibacillary leprosy cases.

Mycobacterium leprae bacilli are mainly transmitted by the dissemination of nasal aerosols from multibacillary (MB) patients to susceptible individuals through inhalation. The upper respiratory tract represents the main entry and exit routes of M. leprae. Therefore, this study aimed to evaluate the sensitivity and specificity of real-time quantitative polymerase chain reaction (qPCR) in detecting M. leprae in nasal secretion (NS) and skin biopsy (SB) samples from MB and paucibacillary (PB) cases. Fifty-four NS samples were obtained from leprosy patients at the Dona Libânia National Reference Centre for Sanitary Dermatology in Ceará, Brazil. Among them, 19 MB cases provided both NS and SB samples. Bacilloscopy index assays were conducted and qPCR amplification was performed using specific primers for M. leprae 16S rRNA gene, generating a 124-bp fragment. Primer specificity was verified by determining the amplicon melting temperature (Tm = 79.5 °C) and detection limit of qPCR was 20 fg of M. leprae DNA. Results were positive for 89.7 and 73.3% of NS samples from MB and PB cases, respectively. SB samples from MB patients were 100% positive. The number of bacilli detected in NS samples were 1.39 × 103-8.02 × 105, and in SB samples from MB patients were 1.87 × 103-1.50 × 106. Therefore, qPCR assays using SYBR Green targeting M. leprae 16S rRNA region can be employed in detecting M. leprae in nasal swabs from leprosy patients, validating this method for epidemiological studies aiming to identify healthy carriers among household contacts or within populations of an endemic area.

Uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): Results of an open label, randomized and controlled clinical trial, among multibacillary patients.

BACKGROUND: Leprosy control is based on early diagnosis and multidrug therapy. For treatment purposes, leprosy patients can be classified as paucibacillary (PB) or multibacillary (MB), according to the number of skin lesions. Studies regarding a uniform treatment regimen (U-MDT) for all leprosy patients have been encouraged by the WHO, rendering disease classification unnecessary. METHODOLOGY AND FINDINGS: An independent, randomized, controlled clinical trial conducted from 2007 to 2015 in Brazil, compared main outcomes (frequency of reactions, bacilloscopic index trend, disability progression and relapse rates) among MB patients treated with a uniform regimen/U-MDT (dapsone+rifampicin+clofazimine for six months) versus WHO regular-MDT/R-MDT (dapsone+rifampicin+clofazimine for 12 months). A total of 613 newly diagnosed, untreated MB patients with high bacterial load were included. There was no statistically significant difference in Kaplan-Meyer survival function regarding reaction or disability progression among patients in the U-MDT and R-MDT groups, with more than 25% disability progression in both groups. The full mixed effects model adjusted for the bacilloscopic index average trend in time showed no statistically significant difference for the regression coefficient in both groups and for interaction variables that included treatment group. During active follow up, four patients in U-MDT group relapsed representing a relapse rate of 2.6 per 1000 patients per year of active follow up (95% CI [0·81, 6·2] per 1000). During passive follow up three patients relapsed in U-MDT and one in R-MTD. As this period corresponds to passive follow up, sensitivity analysis estimated the relapse rate for the entire follow up period between 2·9- and 4·5 per 1000 people per year. CONCLUSION: Our results on the first randomized and controlled study on U-MDT together with the results from three previous studies performed in China, India and Bangladesh, support the hypothesis that UMDT is an acceptable option to be adopted in endemic countries to treat leprosy patients in the field worldwide. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00669643.

Presence of Mycobacterium leprae genotype 4 in environmental waters in Northeast Brazil.

INTRODUCTION:: This study quantified Mycobacterium leprae bacilli in environmental water samples from five municipalities in the State of Ceará by quantitative polymerase chain reaction (qPCR) and compared the identified genotypes with those obtained from leprosy patient biopsies. METHODS:: We collected five replicas from each of the 30 selected reservoirs and skin lesion biopsies from 25 new leprosy cases treated at a reference center in Fortaleza, Ceará from 2010 to 2013. The 16S rRNA gene region of M. leprae was amplified by qPCR and a standard curve was created with the pIDTBlue 16SrRNAMlep plasmid. The Juazeiro do Norte water samples and the biopsies were genotyped (single nucleotide polymorphism [SNP] 1 to 4) and the SNP 4 genotypes were subtyped. RESULTS:: Of the 149 water samples analyzed, 54.4% were positive for the M. leprae DNA. The M. leprae bacilli copy number ranged from 1.42 × 10 -1 to 1.44 × 10 + 2 . Most biopsies showed SNP type 4 (64%), while all samples from Juazeiro do Norte were SNP type 4, with subtype 4-N appearing at the highest frequency. CONCLUSIONS:: We suggest that environmental waters containing M. leprae bacilli play an important role in disease transmission, justifying PGL-1 seropositivity in individuals living in areas where there is no reported case, and in leprosy cases individuals who report no previous contact with other case. Therefore, further investigation is needed to clarify disease transmission in this region and to explore the role of the environment. We also suggest that in this area surveillance for leprosy cases should be intensified.

Presence of Mycobacterium leprae genotype 4 in environmental waters in Northeast Brazil

Abstract INTRODUCTION: This study quantified Mycobacterium leprae bacilli in environmental water samples from five municipalities in the State of Ceará by quantitative polymerase chain reaction (qPCR) and compared the identified genotypes with those obtained from leprosy patient biopsies. METHODS: We collected five replicas from each of the 30 selected reservoirs and skin lesion biopsies from 25 new leprosy cases treated at a reference center in Fortaleza, Ceará from 2010 to 2013. The 16S rRNA gene region of M. leprae was amplified by qPCR and a standard curve was created with the pIDTBlue 16SrRNAMlep plasmid. The Juazeiro do Norte water samples and the biopsies were genotyped (single nucleotide polymorphism [SNP] 1 to 4) and the SNP 4 genotypes were subtyped. RESULTS: Of the 149 water samples analyzed, 54.4% were positive for the M. leprae DNA. The M. leprae bacilli copy number ranged from 1.42 × 10 -1 to 1.44 × 10 + 2 . Most biopsies showed SNP type 4 (64%), while all samples from Juazeiro do Norte were SNP type 4, with subtype 4-N appearing at the highest frequency. CONCLUSIONS: We suggest that environmental waters containing M. leprae bacilli play an important role in disease transmission, justifying PGL-1 seropositivity in individuals living in areas where there is no reported case, and in leprosy cases individuals who report no previous contact with other case. Therefore, further investigation is needed to clarify disease transmission in this region and to explore the role of the environment. We also suggest that in this area surveillance for leprosy cases should be intensified.

Carcinoma basocelular desenvolvido sobre nevo sebáceo: tratamento com terapia fotodinâmica abordando campo de cancerização / Basal cell carcinoma growth over a nevus sebaceous: treatment of the field cancerization with photodynamic therapy

Nevo sebáceo de Jadassohn é hamartoma congênito que pode apresentar evolução para neoplasia cutânea maligna. A terapia fotodinâmica é utilizada para tratamento de ceratoses actínicas e carcinomas basocelulares superficiais ou nodulares, podendo-se observar o campo de cancerização cutâneo através da lâmpada de Wood, durante a realização da técnica. Relata-se um caso do uso da terapia fotodinâmica para o tratamento de um carcinoma basocelular, que se desenvolveu sobre nevo sebáceo, demonstrando-se o campo cancerizável através do uso da lâmpada de Wood. O procedimento consistiu em alternativa de tratamento não cirúrgico para o carcinoma basocelular, com excelente resultado estético. A paciente encontra-se em seguimento clínico, não apresentando recidiva da neoplasia 18 meses após o tratamento.

The sebaceous nevus of Jadassohn is a congenital hamartoma that may develop into a malignant cutaneous neoplasia. Photodynamic therapy is used to treat actinic keratoses and superficial or nodular basal cell carcinomas, and the cutaneous field cancerization can be observed using the Wood's lamp during the performance of the technique. This article describes a case of photodynamic therapy used in the treatment of a basal cell carcinoma, which developed on a sebaceous nevus, where the field cancerization was demonstrated through the use of Wood's lamp. The procedure is a non-surgical alternative for the treatment of the basal cell carcinoma, with excellent aesthetic outcome. The patient is on clinical follow-up, with absence of recurrence of the neoplasia 18 months after the treatment.

Uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): results of an open label, randomized and controlled clinical trial, among multibacillary patients

BACKGROUND: Leprosy control is based on early diagnosis and multidrug therapy. For treatment purposes, leprosy patients can be classified as paucibacillary (PB) or multibacillary (MB), according to the number of skin lesions. Studies regarding a uniform treatment regimen (U-MDT) for all leprosy patients have been encouraged by the WHO, rendering disease classification unnecessary. METHODOLOGY AND FINDINGS: An independent, randomized, controlled clinical trial conducted from 2007 to 2015 in Brazil, compared main outcomes (frequency of reactions, bacilloscopic index trend, disability progression and relapse rates) among MB patients treated with a uniform regimen/U-MDT (dapsone+rifampicin+clofazimine for six months) versus WHO regular-MDT/R-MDT (dapsone+rifampicin+clofazimine for 12 months). A total of 613 newly diagnosed, untreated MB patients with high bacterial load were included. There was no statistically significant difference in Kaplan-Meyer survival function regarding reaction or disability progression among patients in the U-MDT and R-MDT groups, with more than 25% disability progression in both groups. The full mixed effects model adjusted for the bacilloscopic index average trend in time showed no statistically significant difference for the regression coefficient in both groups and for interaction variables that included treatment group. During active follow up, four patients in U-MDT group relapsed representing a relapse rate of 2.6 per 1000 patients per year of active follow up (95% CI [0·81, 6·2] per 1000). During passive follow up three patients relapsed in U-MDT and one in R-MTD. As this period corresponds to passive follow up, sensitivity analysis estimated the relapse rate for the entire follow up period between 2·9- and 4·5 per 1000 people per year. CONCLUSION: Our results on the first randomized and controlled study on U-MDT together with the results from three previous studies performed in China, India and Bangladesh, support the hypothesis that UMDT is an acceptable option to be adopted in endemic countries to treat leprosy patients in the field worldwide.