Usha 2000.
| Methods | Design: randomized controlled trial Generation of allocation sequence: computer‐generated random‐number table Allocation concealment: investigators did not take part in allocation Blinding: none Inclusion of randomized participants in the analysis: 100% |
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| Participants | Number: 88 enrolled (aged over 5 years with a mean age of 21.3 years (ivermectin) and 22.4 years (permethrin); 59 males, 26 females) Inclusion criteria: clinical diagnosis (3 out of burrow/lesions in classical sites/nocturnal itch/family history) or microscopic diagnosis Exclusion criteria: pregnancy; breastfeeding; treatment for scabies within previous 1 month; serious central nervous system, hepatic, cardiac, or renal disease |
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| Interventions | 1. Oral ivermectin 200 µg/kg bodyweight single dose (43 participants)
2. 5% permethrin cream applied topically overnight (45 participants) Not included in this review 3. Second dose of oral ivermectin, 200 µg/kg for treatment failures in intervention group 1 (12 participants) 4. Second topical application 5% permethrin cream for treatment failures in intervention group 2 (1 participant) |
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| Outcomes | 1. Number of participants clinically cured at 2 weeks (defined as symptom improvement)
2. Adverse events Not included is this review: 3. Number of participants clinically cured at 1, 4, and 8 weeks |
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| Notes | Location: India Date: August 1996 to December 1997 Contacts treated with same drug as the index case, except contacts who were children under 5 or pregnant women; these were treated with 12.5% to 25% benzyl benzoate emulsion Author confirmed randomization method and blinding 3 participants in ivermectin group withdrawn due to using additional treatment |
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