01960nas a2200313 4500000000100000008004100001260001700042653001000059653001000069653002400079653003000103653001100133653001100144653002300155653001200178653000900190653001600199653001400215653001300229653000900242653002200251100004000273245011900313300001100432490000700443050001300450520116900463022001401632 2001 d c2001 Apr-Jun10aAdult10aChild10aDouble-Blind Method10aDrug Therapy, Combination10aFemale10aHumans10aLeprostatic Agents10aleprosy10aMale10aMinocycline10aOfloxacin10aRifampin10aSkin10aTreatment Outcome1 a2-3 Lesion Multicentre Trial Group 00aA comparative trial of single dose chemotherapy in paucibacillary leprosy patients with two to three skin lesions. a131-430 v73 aANON20013 a

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.

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