Reacción acneiforme como efecto adverso del apremilast / Acneiform reaction as an adverse effect of apremilast

El apremilast es un fármaco inhibidor de la fosfodiesterasa-4 que modula, a nivel intracelular, la expresión de citoquinas involucradas en la patogenia inflamatoria de la psoriasis. Su uso está indicado en la psoriasis en placas moderada y severa, con buenos resultados clínicos. Los principales efectos adversos son gastrointestinales y, en menos del 2% de los pacientes, dermatológicos, con exantema y foliculitis. Se presenta el caso de un paciente de 42 años que, luego de tomar el apremilast, desarrolló lesiones faciales que correspondieron clínica e histopatológicamente a una reacción acneiforme, con evolución favorable y resolución total del cuadro posterior a la suspensión del medicamento.

Apremilast is a phosphodiesterase-4 inhibitor that modulates the intracellular expression of cytokines, which are involved in the pathogenesis of psoriasis. Apremilast is indicated in moderate to severe plaque psoriasis, and it has shown good clinical results. The main adverse effects occur at a gastrointestinal level, and in less than 2% at the dermatologic level with exanthema and folliculitis. We present a 42-year-old patient that developed facial lesions after taking apremilast. The facial lesions were clinically and histopathologically correspond to an acneiform eruption. The patient evolved favorably and fully recovered after suspending apremilast.

Hipomelanosis macular progresiva: respuesta al tratamiento con minociclina / Progressive macular hypomelanosis: response to treatment with minocycline

La hipomelanosis macular progresiva (HMP) es una dermatosis caracterizada por máculas hipopigmentadas, que se observa con mayor frecuencia en las mujeres y en los fototipos III y IV. Se ha asociado a Cutibacterium acnes (C. acnes) de tipo III como factor etiológico. Se presenta el caso de una paciente de 30 años, con máculas hipopigmentadas redondeadas en el tronco y la raíz de los miembros inferiores, de 10 años de evolución. El estudio histológico informó disminución del número de melanocitos y de pigmento melánico en la capa basal e infiltrado inflamatorio mononuclear perivascular superficial. Se indicó minociclina 100 mg/día por vía oral durante 8 meses, tras lo cual se observó la resolución total de las lesiones.

Progressive macular hypomelanosis (PMH) is a dermatosis characterized by hypopigmented macules, most frequently found in females and in phototypes III and IV. Cutibacterium acnes (C. acnes) type III has been associated as an etiological factor. We present the case of a thirty-year-old female patient with a 10-year history of nummular hypopigmented macules located on the top of the lower limbs and on the trunk. The histological study reported a decrease in the number of melanocytes and melanotic pigment in the basal layer and the presence of superficial perivascular mononuclear inflammatory infiltrate. After an 8-month regimen of oral minocycline 100 mg/day, there was a complete resolution of the lesions.

Personality disorder and functioning in major depressive disorder: a nested study within a randomized controlled trial

Objective: This study aimed to determine if personality disorder (PD) predicted functional outcomes in patients with major depressive disorder (MDD). Methods: Data (n=71) from a double-blind, randomized, placebo-controlled 12-week trial assessing the efficacy of 200 mg/day adjunctive minocycline for MDD were examined. PD was measured using the Standardized Assessment of Personality Abbreviated Scale. Outcome measures included Clinical Global Impression - Improvement (CGI-I), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), Social and Occupational Functioning Scale (SOFAS), and Range of Impaired Functioning (RIFT). Analysis of covariance was used to examine the impact of PD (dichotomized factor [≥ 3] or continuous measure) on the outcome measures-treatment group correlation. Results: PD was identified in 69% of the sample. After adjusting for age, sex, and baseline scores for each of the outcome measures, there was no significant difference between participants with and without PD on week 12 scores for any of the outcome measures (all p > 0.14). Conclusion: In this secondary analysis of a primary efficacy study, PD was a common comorbidity among those with MDD, but was not a significant predictor of functional outcomes. This study adds to the limited literature on PD in randomized controlled trials for MDD. Clinical trial registration: ACTRN12612000283875.

Worrisome trends in rising minimum inhibitory concentration values of antibiotics against methicillin resistant Staphylococcus aureus - Insights from a tertiary care center, South India

ABSTRACT INTRODUCTION: Appearance of isolated reports of resistance to anti-methicillin-resistantStaphylococcus aureus (MRSA) drugs is worrisome underscoring the need to continuously monitor the susceptibility of clinical MRSA isolates to these drugs. Hence, the present study is conducted to determine the susceptibility of MRSA isolates to various classes of anti-MRSA drugs such as vancomycin (glycopeptide), daptomycin (lipopeptide), tigecycline (glycylcycline), and linezolid (oxazolidinone) to determine the MIC50 and MIC90 values, and to observe MIC creep over a three year period, if any, with respect to these drugs. METHODS: A total of 200 isolates of MRSA obtained from clinical specimens were included. MIC was determined by E-test for anti-MRSA antibiotics vancomycin, linezolid, daptomycin, and tigecycline. Non-parametric methods (Kruskal-Wallis and Chi-square test) were used to assess MIC trends over time. In addition, MIC50 and MIC90 values were also calculated. RESULTS: No isolate was found resistant to vancomycin, daptomycin, or linezolid; five isolates were resistant to tigecycline. Seven VISA isolates were encountered with the MIC value for vancomycin of 4 µg/mL. MIC values for vancomycin, tigecycline, linezolid showed a definite increase over a 3-year period which was statistically significant with p-values <0.0001, 0.0032, 0.0242, respectively. When the percentage of isolates with a median MIC value less than or equal to that of the index year was calculated, the change was most striking with vancomycin. The proportion of isolates with higher MIC values was greater in 2014 than 2012 and 2013. CONCLUSION: MIC creep was notably observed with vancomycin, and to some extent with tigecycline and linezolid. Selection pressure may result in creeping MICs, which may herald the emergence of resistant organisms.

A randomized controlled trial to compare cure and relapse rate of paucibacillary multidrug therapy with monthly rifampicin, ofloxacin, and minocycline among paucibacillary leprosy patients in Agra District, India.

To study cure rate and relapse rate of standard World Health Organization paucibacillary multidrug therapy (PB-MDT) with monthly rifampicin, ofl oxacin, and minocycline for six months (ROM-6) among paucibacillary leprosy patients. Methods: A total of 268 patients, detected during active search in Agra district during 2001–2004, who had paucibacillary (PB) leprosy having 1–5 skin lesions and/or one nerve thickening/tenderness, were allocated, using random number tables, to two treatment groups; PB-MDT and ROM-6. On the fi rst day of the month, dose of PB-MDT and of the ROM were given under supervision for 6 months. After completion of drug therapy, patients were followed every 6 months for fi rst 5 years and later annually for next 3 years for monitoring disease status, cure rates, reactions and relapses. Chi square test was used to compare relapse rates. Results: The cure rate at 2 years was 99% in ROM-6 and 97.0% in PB-MDT group, of those who completed treatment and the difference was statistically not signifi cant. At 5 years, only 88 patients in PB-MDT group and 90 patients in ROM-6 group could be followed; all were observed to be cured. However, during the period of 5-8 years, 3 of 67 patients in PB-MDT group and 1 of 73 in ROM-6 group were observed to have relapsed. In all, 10 relapses were noted (3 in ROM-6 and 7 in PB-MDT group) giving a relapse rate of 1.10/100 person years in PB-MDT and 0.435/100 person years in ROM groups (P = 0.053; statistically not signifi cant). Of the 10 relapses, 5 occurred within 5 years (3 in PB-MDT group and 2 in ROM-6), 4 during 5–8 years (3 in PB-MDT and 1 in ROM-6), and 1 occurred in MDT group after 8 years. Limitation: A number of patients were lost to follow up after release from treatment and thus actual number of relapses in the study could not be assessed. Additionally, diagnosis was purely clinical and histology could not be done for reasons related to functional diffi culties in the fi eld. Conclusion: The study shows that PB-MDT and ROM-6 have almost similar acceptability, cure rate and relapse rate.

Pyoderma Gangrenosum: A Case Series.

Pyoderma gangrenosum is a rare, ulcerative, non-infectious neutrophilic dermatosis, commonly associated with underlying systemic disease. The features of pyoderma gangrenosum are not specific histopathologically and for this reason the diagnosis is based on clinical feature. The systemic administration of corticosteroids is the mainstay of treatment. We present five cases of pyoderma gangrenosum of age group ranging from 2 to 75 years. One of these patients was HIV-infected, and one was having discoid lupus erythematosus. The lesions were present on thighs in 3 cases, over back in one and breast in one. Biopsy showed central necrosis with multiple neutrophilic abscesses in epidermis. The dermis showed dense neutrophilic infiltration in both superficial and deep dermis. The lesions responded well to oral corticosteroids except in the case of HIV-infected patient in which minocycline showed considerable improvement.

Monthly rifampicin, ofloxacin, and minocycline therapy for generalized and localized granuloma annulare.

Background: The localized form of granuloma annulare is usually self‑limiting, resolving within 2 years. Generalized granuloma annulare, on the other hand, runs a protracted course, with spontaneous resolution being rare. It is also characterized by a later age of onset, an increased incidence of diabetes mellitus, poor response to therapy, and an increased prevalence of HLA Bw35. Objective: To assess the efficacy of monthly pulsed rifampicin, ofloxacin, and minocycline (ROM) therapy in the management of granuloma annulare.Methods: Six biopsy proven patients of granuloma annulare were included in the study, five of the generalized variety, and one localized. Three of these patients were resistant to standard modalities of treatment. All six patients were treated with pulses of once monthly ROM till complete resolution of all lesions. Results were analyzed in terms of complete resolution of lesions and side effects. Presence of comorbid conditions was noted. Result: All six patients were successfully treated with 4-8 pulses of monthly ROM. None of the patients reported any adverse effects. Limitations: Small sample size and the lack of a control group are limitations. Conclusion: Treatment with pulses of once monthly ROM caused complete resolution of lesions in both localized and generalized granuloma annulare, even in cases recalcitrant to conventional therapy. There were no side effects in any of the patients. Larger trials are needed to substantiate the efficacy of monthly ROM in granuloma annulare.

Randomized controlled study to evaluate the effectiveness of dexamethasone oral minipulse therapy versus oral minocycline in patients with active vitiligo vulgaris.

Background: Oral minocycline has been recently shown to halt disease progression in active vitiligo. Aims: The present study was planned to compare the efficacy and tolerability of oral minocycline with oral mini pulse (OMP) corticosteroids in active vitiligo. Methods: A total of 50 patients with actively spreading vitiligo were randomized to receive either minocycline 100 mg/day (Group I - 25 patients) or OMP 2.5 mg dexamethasone on 2 consecutive days in a week (Group II - 25 patients) for 6 months. These were followed-up at every 2 weeks interval. Mean vitiligo disease activity score (VIDA) and mean Vitiligo Area Scoring Index (VASI) were assessed in all patients in addition to the photographic comparison before and after treatment. Results: Both groups showed a significant decrease in VIDA from 4.0 to 1.64 ± 0.86 (P < 0.001) in Group I and from 4.0 to 1.68 ± 0.69 (P < 0.001) in Group II. However, the difference between the mean VIDA scores in the two groups was not statistically significant (P = 0.60) at the end of treatment period. The mean VASI declined from 1.71 ± 1.45 to 1.52 ± 1.43 Group I (P = 0.06) and from 1.39 ± 1.31 to 1.17 ± 1.34 in Group II (P = 0.05). The difference between VASI in Group I and II was not significant at the end of 24 weeks of treatment (P = 0.11). Conclusion: Both dexamethasone OMP and oral minocycline are effective drugs for managing the arrest of disease activity in vitiligo.

Adverse effects of alternative therapy (minocycline, ofloxacin, and clofazimine) in multibacillary leprosy patients in a recognized health care unit in Manaus, Amazonas, Brazil / Efeitos adversos das drogas (minociclina, ofloxacina e clofazimina) utilizadas no esquema alternativo para pacientes com hanseníase multibacilar, em unidade de referência, Manaus, Amazonas, Brasil

BACKGROUND: After the introduction of the multidrug therapy, there was a decline in the coefficients of prevalence and detection of new cases of leprosy. However, the records of drug resistance and relapses are threatening factors in leprosy control. Hence, new alternative schemes and monitoring of adverse effects to avoid treatment abandonment are important considerations. OBJECTIVE: Describe the side effects of a multidrug regimen containing minocycline, ofloxacin, and clofazimine in multibacillary leprosy patients. METHODS: We conducted a prospective, descriptive, and observational study with multibacillary patients, including cases of intolerance to standard MDT and relapses. The study was carried out at Fundação Alfredo da Matta (Alfredo da Matta Foundation), in Manaus, Amazonas, from April 2010 to January 2012. The patients received alternative therapy, which consisted of daily self-administered doses of 100mg of minocycline, 400 mg of ofloxacin, and 50mg of clofazimine and a supervised monthly dose of 300mg of clofazimine for six months, followed by eighteen months of daily doses of ofloxacin 400mg, clofazimine 50mg, and a supervised monthly dose of clofazimine 300mg. Results: Twenty-one cases were included. Mild and transitory side effects occurred in 33.3% of patients. Of the total episodes, 45.9% were attributed to ofloxacin and they included abdominal pain, nausea, vomiting, headache, and insomnia; 21.6% were due to clofazimine, with 100% of patients presenting skin pigmentation. The mean time for the development of adverse effects after beginning the therapy was 15.2 days. CONCLUSION: All patients tolerated the drugs well, and compliance was satisfactory, with no serious events. Unlike other standard MDT studies ...

FUNDAMENTOS: Após introdução do esquema poliquimioterápico padrão, houve declínio nos coeficientes de prevalência e detecção de casos novos; entretanto, os registros de resistência medicamentosa e recidivas representam ameaça para o controle da hanseníase. Dessa forma, a proposição de novos esquemas alternativos e a necessidade de monitorar efeitos adversos são importantes para evitar o abandono do tratamento. OBJETIVO: Descrever efeitos adversos do esquema alternativo contendo clofazimina, ofloxacina e minociclina em pacientes com hanseníase multibacilar. MÉTODOS: Estudo prospectivo, descritivo e observacional de casos multibacilares, incluindo recidivas ou intolerância à poliquimioterapia padrão, realizado na Fundação Alfredo da Matta, Manaus, Amazonas, de abril de 2010 a janeiro de 2012. Os indivíduos receberam a terapia composta de doses diárias auto-administradas de 100mg de minociclina, 400mg de ofloxacina e 50mg de clofazimina e mensais supervisionadas de 300mg de clofazimina por seis meses, seguidas de 18 meses de doses diárias de ofloxacina 400mg, clofazimina 50 mg e supervisionadas mensais de clofazimina 300mg. Resultados: 21 pacientes foram incluídos. Efeitos adversos leves e transitórios foram observados em 33,3% dos pacientes; 45,9% foram atribuídos à ofloxacina, como dor abdominal, náuseas, vômitos, cefaléia e insônia; 21,6% foram associados à clofazimina, com relatos e observação em 100% dos pacientes de hiperpigmentação cutânea. O tempo médio de desenvolvimento das reações adversas a partir do início do esquema foi de 15,2 dias. ...

Avaliação de hansenianos tratados com esquema alternativo dose única ROM (rifampicina, ofloxacina e minociclina), após sete a nove anos / Evaluation years in leprosy patients treated with single dose alternative scheme ROM (rifampin, ofloxacin, minocycline), after seven to nine

INTRODUÇÃO: Em 1997, após a realização de estudo multicêntrico, duplo cego e randomizado, em nove centros de tratamento de hanseníase na Índia, o Ministério da Saúde adotou o esquema alternativo dose única ROM para casos de lesão única, paucibacilar, sem nervo periférico afetado, índice baciloscópico negativo, em Centros de Referência da doença no Brasil. O estudo se propôs a avaliar a efetividade do esquema ROM em pacientes tratados no período de 1997 a 1999 no Serviço de Dermatologia da Santa Casa de Vitória. MÉTODOS: Foram selecionados e tratados com o esquema ROM, 54 pacientes das formas indeterminada e tuberculóide. Estes pacientes foram convocados de março a outubro de 2006 para reavaliação clínica. RESULTADOS: Vinte e nove pacientes avaliados (85,2 por cento; IC95 por cento: 70-100,4) estavam curados, cinco (14,7 por cento; IC95 por cento: 7,4-22,0) recidivaram e 20 pacientes não retornaram; porém, não havia outra notificação de reingresso ao tratamento no banco de dados da Secretaria Estadual de Saúde. CONCLUSÕES: O estudo evidenciou taxa de cura de 90,8 por cento e taxa bruta de recidiva de 9,2 por cento, após período de sete a nove anos da dose ROM. O tratamento alternativo ROM demonstrou melhor efetividade para lesão única menor que quatro centímetros e aparecimento há menos de cinco anos.

INTRODUCTION: In 1997, after obtaining a combined multi-state double-blind randomly controlled clinical trial study from nine Indian centers involved in the treatment of Hansen's Disease, the Ministry of Health adapted the single dose ROM Therapy approach in those cases involving the treatment of a single skin lesion, paucibacillary leprosy without evidence of peripheral nerve trunk involvement and indication of negative baciloscope, in the Referral Centers in Brazil. The study aimed to evaluate the effectiveness of the single dose ROM Therapy approach in those patients who were treated from the period of 1997 to 1999 in the Ambulatory Dermatologic Unit in the Hospital in Vitória, ES. METHODS: Fifty-four patients with tuberculoid and indeterminate leprosy were selected and treated with the single dose ROM Therapy approach. These patients were contacted from March 2006 up and until October 2006 for further clinical reevaluation. RESULTS: From the studies conducted, the following results were found to exist: 29 patients (85,2 percent; 95 percentCI: 70-100,4) were cured, 5 patients (14,7 percent; 95 percentCI: 7,4-22,0) relapsed, and 20 patients didn't return; however, there are no additional records of any notification of other treatment(s) in the State Department of Health's informational data banks. CONCLUSIONS: The study demonstrated a rate of cure of 90.8 percent and a rate of relapse of 9.2 percent after a period of seven to nine years using the single dose ROM Therapy approach. Additionally, this alternative treatment further demonstrated a better effectiveness for a single skin lesion smaller than four centimeters and with an appearance in less than five years.

Tigecycline.

Infection with resistant pathogens can adversely affect clinical, microbiological and economic outcomes. New agents for the treatment of many such serious infections are acutely needed in hospital practice. Tigecycline is a novel glycylcycline antimicrobial for intravenous use. It has an expanded broad-spectrum antibacterial activity including multi-drug resistant pathogens, like methicillin-resistant Staphylococcus aureus , vancomycin-resistant enterococci , multi-drug resistant Streptococcus pneumoniae , extended-spectrum beta-lactamase-producing gram-negative bacteria and Acinetobacter baumannii . Tigecycline however is not active against Proteus, Providencia and Pseudomonas species. Its currently approved indications include complicated skin and skin structure infections and complicated intra-abdominal infections. It has also been found to be effective for the treatment of community- as well as hospital-acquired and ventilator-associated pneumonia and bacteremia, sepsis with shock and urinary tract infections. Tigecycline appears to be a valuable treatment option for the management of superbugs, especially where conventional therapy has failed.

A comparative evaluation of skin and nerve histopathology in single skin lesion leprosy.

BACKGROUND: In spite of leprosy being a disease of nerves, ROM therapy for single skin lesion leprosy was based on clinical trials without much evidence-based studies of nerve pathology. The present study was undertaken to compare the histology of skin and nerve in single skin lesion leprosy, and to assess the scientific rationale and justification of single dose ROM therapy. METHODS: Twenty-seven untreated patients with single skin lesion without significantly thickened peripheral nerves were selected. Skin and nearby pure cutaneous nerve biopsies were studied under both H&E and Fite's stain. RESULTS: All the skin biopsies were negative for AFB and clinico-pathological correlation was positive in 51.85% of skin biopsy specimens. Histopathological diagnosis of leprosy was evident in 55.5% of clinically normal looking nerves, with AFB positivity in 29.6% of nerve biopsy specimens. Correlation between clinical diagnosis and nerve histopathology was poor (26%). CONCLUSIONS: Single skin lesion without thickened peripheral nerves as criteria for single dose ROM therapy is not logical, since the histological diagnosis of leprosy in normal looking nerves with presence of AFB is revealed in this study. Pure cutaneous nerve biopsy is a simple outpatient procedure, without complications. This study emphasizes the need to consider nerve pathology as an important tool for further therapeutic recommendations, than just clinical trials and skin pathology alone. Though single dose ROM therapy has been withdrawn recently, the principle holds good for any future therapeutic recommendations.

Correlação entre dose/concentração plasmática e avaliação de alterações hepáticas e renais em ratos Wistar tratados com o esquema ROM / Correlation between dose/plasma concentration and assessment of hepatic and renal changes in Wistar rats treated with the ROM scheme

A hanseníase, doença crônica, granulomatosa, infecto-contagiosa, transmitida pelo Mycobacterium leprae, ainda se mantém prevalente nos dias atuais, principalmente em países subdesenvolvidos e a sua forma paucibacilar com lesão única, vem sendo tratada através da administração de rifampicina (600mg), ofloxacina (400mg) e minociclina (100mg), em dose única (esquema ROM). Assim, o objetivo deste trabalho foi investigar a correlação dose/concentração plasmática versus alterações bioquímicas na administração da rifampicina, ofloxacina e minociclina a ratos machos Wistar, em regime de dose única em mono e politerapia. Concluímos que a rifampicina e a ofloxacina sofreram um aumento na concentração plasmática quando administrados em politerapia, enquanto que a minociclina sofreu uma redução, provavelmente por interferências na biotransformação e excreção. Constatamos através das análises bioquímicas que a rifampicina provavelmente é a responsável por alterações hepáticas e renais, e que as interações medicamentosas envolvendo o fármaco exigem estudos individualizados principalmente quando o fármaco é usado associado a ofloxacina e minociclina.

Lesional characteristics and histopathology in paucibacillary leprosy patients with 2 or 3 skin lesions: comparison between ROM and PB-MDT regimens.

Paucibacillary (PB) patients form a large segment of newly diagnosed leprosy patients and those who present with only two or three skin lesions could have problems with compliance. With prolonged anti-leprosy drug regimens that last over six months. ROM therapy, a one-dose regimen, offers an attractive alternative in treating such patients. We conducted a longitudinal study of 51 such PB patients, placing them in two groups at random: one receiving the standard PB-MDT regimen, and the other the ROM regimen. Patients were followed up for 2 years, with a comprehensive clinical examination done every six months. 14 patients, 7 in each group, also had their skin biopsies evaluated histopathologically at recruitment, at 6 months and at the end of 2 years. There was a consistent improvement of lesions in both the groups over time. The fall in granuloma fraction and the clearance of the initial bacterial index were seen in the histopathology of both groups. Although the PB-MDT regimen is an effective and robust one, the operational convenience and drug compliance with ROM could make it an acceptable, parallel regimen for PB patients when the disease is localized to 2 or 3 skin lesions.

Chemotherapy of leprosy.

The WHO MDT regimens have proved highly successful in preventing relapse of leprosy cases. It has indirectly lad to marked reduction in prevalence of disabilities. For PB leprosy, rifampicin 600 mg monthly and 100 mg dapsone daily for a total of 6 months therapy is required. For MB leprosy clofazimine 300 mg once monthly, supervised and 50 mg daily self administered is added. For single skin lesion the current WHO recommendation is 600 mg rifampicin + 400 mg ofloxacin + 100 mg minocycline given as a single dose for adults. Dose adjustment for children and clinical information have been discussed in a nutshell. A number of trials are going on, some are yet to be completed which do offer the prospect of perhaps simplifying therapy and improving with shorter duration.

A comparative clinico-pathological study of single dose ROM in paucibacillary leprosy patients with 1-3 skin lesions.

A controlled clinical and histopathological study was carried out to compare the efficacy of a combination of rifampicin 600 mg plus ofloxacin 400 mg plus minocycline 100 mg (ROM) administered as a single dose with that of standard WHO/MDT-PB six months' regimen with regard to resolution of lesion clinically and histopathologically. Skin biopsy was performed at the intake and at 6 months. The study subjects were 32 previously untreated, smear-negative patients, without nerve trunk involvement and having 1-3 skin lesions. The results were analyzed for mean clinical score for marked, moderate and no improvement and mean histopathological score was graded as active, resolving and complete resolution, according to granuloma fraction at the end of 6 months. Marked clinical improvement was seen in 25% and 12%, moderate improvement in 50% and 56% patients treated with ROM and standard regimens respectively. Histopathologically, activity was seen in 62.5% and 43.7% and resolution of granuloma in 25% and 31.2% in the ROM and standard regimens respectively. Both the regimens were equally efficacious in the reduction of clinical score and granuloma fraction. No adverse drug reactions or reversal reactions were seen during the study period in both the groups.

A comparative trial of single dose chemotherapy in paucibacillary leprosy patients with two to three skin lesions.

A multicentric, double-blind, controlled, clinical trial was carried out to compare the efficacy of a combination of rifampicin 600 mg plus ofloxacin 400 mg plus minocycline 100 mg (ROM) administered as single dose with that of standard WHO/MDT/PB six months regimen. The study subjects were 236 previously untreated, smear-negative patients, without nerve trunk involvement and having only two or three skin lesions. Randomization was done on individual patient basis. Results were analyzed for mean clinical score for improvement, marked clinical improvement and complete clinical cure at the time of release from treatment and at 12 months and 18 months of follow-up. Clinical improvement was seen in most patients in both regimens. Marked improvement (i.e., more than 90% reduction in clinical score) at 18 months was seen in 46.2% and 53.4% of the patients treated with ROM and standard regimens, respectively. But, significant difference in favour of standard PB regimen was seen in patients with three skin lesions and in patients in whom more than one body part was affected. Reversal reaction and adverse drug reactions were minimal in both groups.