Chouela 1999.
Methods | Design: randomized controlled trial Generation of allocation sequence: unclear Allocation concealment: unclear Blinding: participants (study described as double blind) Inclusion of randomized participants in the analysis: 81% (10/53 participants lost to follow up or withdrew) |
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Participants | Number: 53 enrolled (aged over 18 years with a mean age of 40.8 years; 19 males, 34 females) Inclusion criteria: clinical or parasitological signs compatible with scabies Exclusion criteria: pregnancy; breastfeeding; treatment for scabies within previous 4 weeks; renal dysfunction; hepatic dysfunction; concomitant antidepressant; anxiolytic or antipruritic drug use; severe immunodeficiency; HIV infection; clinically high risk for HIV; neoplasia affecting immunity; immunosuppressive treatment; gastrointestinal dysfunction; history of convulsions |
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Interventions | 1. Single dose of oral ivermectin, 150 to 200 µg/kg in 6 mg tablets plus single topical application of 60 mL placebo solution (26 participants)
2. Single topical application of 60 mL 1% lindane topical solution plus placebo tablets (27 participants) Both placebo and 1% lindane solutions applied neck to toe and kept on for 8 h Not included in this review: 3. Second dose of oral ivermectin, 150 to 200 µg/kg in 6 mg tablets plus single topical application of 60 mL placebo solution at 15 days for treatment failures in intervention group 1 (ivermectin) 4. Second topical application of 60 mL 1% lindane topical solution plus placebo tablets at 15 days for treatment failures in intervention group 2 (lindane) |
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Outcomes | 1. Number of participants cured at 15 days (defined as absence of pruritus and clinical lesions or a reduction of signs and symptoms to a score of 1 (mild pruritus and mild lesions))
2. Adverse events Not included in this review 3. Number of participants receiving second dose at 15 days who were cured at 29 days |
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Notes | Location: Argentina Date: April 1996 to February 1997 Members of the same household who were infested but could not be included in the study treated with 1% lindane (adults) or 6% sulfur cream (infants) |