Characteristics of included studies [ordered by study ID]
Amer 1992
|
| Methods | Design: randomized controlled trial
Generation of allocation sequence: "according to code"
Allocation concealment: unclear
Blinding: unclear
Inclusion of randomized participants in the analysis: 100% |
|
| | Participants | Number: 150 enrolled (all ages; sex not stated)
Inclusion criteria: clinically diagnosed and microbiologically confirmed scabies
Exclusion criteria: significant impetiginization |
|
| | Interventions | 1. 5% permethrin (50 participants)
2. 10% crotamiton (50 participants)
3. 1% lindane (50 participants)
Each medication applied "neck to toe" on 2 successive nights |
|
| | Outcomes | 1. Number of participants clinically cured (no new lesions and all original lesions healed) at 28 days |
|
| | Notes | Location: Egypt
Date: not stated
Colour photographs used for comparison before and after treatment |
|
|
Amerio 2003
|
| Methods | Design: randomized controlled trial
Generation of allocation sequence: computer generated
Allocation concealment: phone call-based procedure
Blinding: investigators only
Inclusion of randomized participants in the analysis: 100% |
|
| | Participants | Number: 40 enrolled (mean age 44, standard deviation 17; 19 males, 21 females)
Inclusion criteria: immunocompetent; aged 18 to 75; microscopically confirmed uncomplicated scabies
Exclusion criteria: HIV positive; severe renal failure; liver insufficiency; acute or chronic leukaemia; lymphoma; use of antiscabietic preparations in previous 30 days; pregnancy; breastfeeding |
|
| | Interventions | 1. 5% permethrin cream (20 participants)
2. 0.16% natural pyrethrins synergized with pyperonil butoxide (1.65%) in thermolabile foam ("Milice", Mipharm, Italy) (20 participants)
Both medications applied to entire body surface except head for 8 h overnight on 2 consecutive days, and then same treatment repeated after 14 days |
|
| | Outcomes | 1. Number of participants with clearance of lesions at 4 weeks
2. Number of participants with complete relief of itching at 4 weeks
Not included in this review:
3. Number of participants with clearance of lesions at 2 weeks
4. Number of participants with complete relief of itching at 2 weeks
5. Clinical grading score (semi-quantitative measure of numbers of lesions) at 2 and 4 weeks
6. Itching score at 2 and 4 weeks
7. Numbers of days taking antihistamine drugs
8. Numbers of participants with secondary skin infection |
|
| | Notes | Location: Italy
Date: March 2001 to October 2001
Trial supported by unrestricted grant from Mipharm SpA |
|
|
Avila-Romay 1991
|
| Methods | Design: randomized controlled trial
Generation of allocation sequence: "randomly assigned"
Allocation concealment: unclear
Blinding: unclear
Inclusion of randomized participants in the analysis: 100% |
|
| | Participants | Number: 51 cases and 60 contacts enrolled (children 6 to 17 years old; sex not stated)
Inclusion criteria: clinically compatible lesions associated with itching
Exclusion criteria: secondary infection |
|
| | Interventions | 1. 10% sulfur in pork fat with 1% salicylic acid as preservative (25 cases and 28 contacts)
2. 10% sulfur in cold cream (26 cases and 32 contacts)
Both medications applied nightly for 3 nights then once 3 nights later, average dose 7 g
Both medications applied by the patients from shoulders to feet for about 5 minutes, under supervision of a physician |
|
| | Outcomes | 1. Number of participants clinically cured at 10 days (defined as absence of cutaneous lesions and itching)
2. Secondary cutaneous reactions in cases and contacts
Not included in this review:
3. Patient preference (not further defined) |
|
| | Notes | Location: Mexico; participants from a house for orphan children
Date: not stated
60 contacts also randomly assigned to treatment with sulfur in either pork fat or cold cream |
|
|
Bachewar 2009
|
| Methods | Design: randomized controlled trial
Generation of allocation sequence: computer generated
Allocation concealment: unclear
Blinding: none
Inclusion of randomized participants in the analysis: 78% (23/103 lost to follow up) |
|
| | Participants | Number: 103 enrolled (aged over 12; 63 males, 40 females)
Inclusion criteria: clinically diagnosed scabies
Exclusion criteria: pregnancy; lactation; women of child bearing age; abnormal liver or kidney function; thyroid disease; cardiac disorders; nervous system disorders; psychiatric illness; diabetes mellitus; hypertension; chronic infectious disease; any concurrent medication; consuming tobacco, alcohol, or any substance of abuse; any other associated skin disease which could alter the picture of scabies; known/suspected immunocompromised individuals; having scabies with atypical presentations including crusted scabies and scabies incognito; any antiscabetic treatment in the preceding week; noncompliant participants. |
|
| | Interventions | 1. 25% benzyl benzoate lotion applied to whole body below neck and left overnight, on 2 consecutive nights (35 participants)
2. 5% permethrin cream applied to whole body below neck and left overnight (34 participants)
3. Oral ivermectin 200 µg/kg bodyweight single dose (34 participants)
Not included in this review:
4. Second topical application of 25% benzyl benzoate lotion at 1 week for treatment failures in intervention group 1 (benzyl benzoate)
5. Second topical application of 5% permethrin cream at 1 week for treatment failures in intervention group 2 (permethrin)
6. Second dose of oral ivermectin at 1 week for treatment failures in intervention group 3 (ivermectin) |
|
| | Outcomes | 1. Number of participants cured at 1 week (defined as absence of new papules, vesicles or classical burrows)
2. Adverse events
Not included in this review:
3. Number of participants cured at 2 weeks (defined as absence of new papules, vesicles or classical burrows)
4. Itching recorded on visual analogue scale |
|
| | Notes | Location: Nagpur, India
Date: March to July 2007
All family members and close contacts treated at same time as the participant with 25% benzyl benzoate lotion |
|
|
Biele 2006
|
| Methods | Design: randomized controlled trial
Generation of allocation sequence: computer generated
Allocation concealment: unclear
Blinding: investigators
Inclusion of randomized participants in the analysis: 100% |
|
| | Participants | Number: 240 enrolled (aged 18 to 75 years, mean age 31 years (pyrethrin group) and 30 years (benzyl benzoate); males only)
Inclusion criteria: clinically diagnosed and microscopically confirmed scabies
Exclusion criteria: treatment for scabies within previous 15 days; renal failure (plasma creatinine > 2.5 mg/dL); liver insufficiency (alanine aminotransferase or aspartate aminotransferase > 3 upper normal limit); acute or chronic leukaemia or lymphoma |
|
| | Interventions | 1. 10% benzyl benzoate lotion ("SCAB", PentaMedical, Milan, Italy), topical application on 5 consecutive days (120 participants)
2. 0.165% natural pyrethrins synergized with pyperonil butoxide (1.65%) in thermolabile foam ("Milice", Mipharm, Italy), topical application on 3 consecutive days (120 participants)
Both treatments were applied to all skin surfaces from scalp to soles of feet
Treatment was repeated after 2 weeks if participant was not considered clinically cured |
|
| | Outcomes | 1. Number of participants clinically cured at 4 weeks
2. Number of participants with relief of itching at 4 weeks
3. Adverse events
Not included in this review:
4. Number of participants with clearance of lesions at 2 weeks
5. Clinical grading score (semi-quantitative measure of numbers of lesions) at 4 weeks
6. Itching score at 4 weeks |
|
| | Notes | Location: Italy
Date: October 2003 to July 2004 |
|
|
Brooks 2002
|
| Methods | Design: randomized controlled trial
Generation of allocation sequence: computer generated
Allocation concealment: unclear
Blinding: investigators
Inclusion of randomized participants in the analysis: 73% (30/110 lost to follow up) |
|
| | Participants | Number: 110 enrolled (children 6 months to 14 years old; sex not stated)
Inclusion criteria: clinically diagnosed scabies
Exclusion criteria: treatment for scabies within previous 2 months; major intercurrent illness; history of meningitis or neurological illness |
|
| | Interventions | 1. Oral ivermectin 200 µg/kg bodyweight single dose (55 participants)
2. 10% benzyl benzoate applied neck to toe overnight (55 participants) |
|
| | Outcomes | 1. Number of participants clinically cured at 3 weeks (defined as absence of skin lesions)
2. Number of participants with persistence of night-time itch at 3 weeks
3. Adverse events
Not included in this review
4. Itch severity
5. Numbers of lesions |
|
| | Notes | Location: Vanuatu
Date: January to April 2001
Family contacts treated with same drug as the participant
Author confirmed equal numbers of participants randomized to each intervention |
|
|
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) |
|
| | 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 |
|
| | 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) |
|
| | 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 |
|
| | 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) |
|
|
Glaziou 1993
|
| Methods | Design: randomized controlled trial
Generation of allocation sequence: "randomly allocated"
Allocation concealment: unclear
Blinding: outcomes assessor
Inclusion of randomized participants in the analysis: 100% |
|
| | Participants | Number: 44 enrolled (aged 5 to 56 years, mean 17.5 years; 23 males, 21 females)
Inclusion criteria: clinically diagnosed scabies defined as the association of pruritus with at least 1 classical burrow
Exclusion criteria: other disease; pregnancy; abnormal physical examination (except for cutaneous lesions); abnormal laboratory screen; refused consent |
|
| | Interventions | 1. Oral ivermectin 100 µg/kg bodyweight single dose (23 participants)
2. 10% benzyl benzoate applied to entire body except head on 3 occasions 12 h apart (21 participants) |
|
| | Outcomes | 1. Number of participants clinically cured at 30 days (defined as complete disappearance of initial lesions and pruritus)
2. Adverse events
Not included in this review:
3. Number of participants clinically cured at 7 days
4. Number of participants clinically cured at 14 days
5. Mean clinical score (based on number and activity of lesions) |
|
| | Notes | Location: French Polynesia
Date: 1992
All household contacts treated at same time as the participant with 10% benzyl benzoate
Merck Sharp and Dohme supplied the ivermectin tablets at no cost |
|
|
Gulati 1978
|
| Methods | Design: randomized controlled trial
Generation of allocation sequence: "cases ... divided at random"
Allocation concealment: unclear
Blinding: unclear
Inclusion of randomized participants in the analysis: 100% |
|
| | Participants | Number: 158 enrolled (mean age 16.6 years; 75 males, 83 females)
Inclusion criteria: clinical diagnosis of scabies
Exclusion criteria: none stated |
|
| | Interventions | 1. 25% benzyl benzoate emulsion (89 participants)
2. Sulfur ointment (69 participants)
Both medications "applied all over the body after a thorough scrub bath with soap and water once in the morning, then again at night and again the next morning"
Treatments were repeated in those whose lesions persisted after the 10th day |
|
| | Outcomes | 1. Number of participants with clinically assessed "clearance of lesions" at 15 days
Not included in this review:
2. Numbers of participants with clearance of lesions at 3 to 5, 6 to 8, 9 to 11, and 12 to 14 days
3. Number of days until clearance of lesions |
|
| | Notes | Location: India
Date: not stated
Family contacts treated concurrently with same drug as the participant
33% of participants had secondarily infected lesions
Prevalence of scabies in this study was 158/1727 (9.1%) |
|
|
Hansen 1986
|
| Methods | Design: randomized controlled trial
Generation of allocation sequence: unclear
Allocation concealment: unclear
Blinding: unclear, "single blind"
Inclusion of randomized participants in the analysis: 95% (5/104 lost to follow up) |
|
| | Participants | Number: 104 enrolled (aged 2 to 71 years)
Inclusion criteria: clinical and/or microscopic diagnosis of scabies
Exclusion criteria: none stated |
|
| | Interventions | 1. 1% lindane lotion (50 participants)
2. 5% permethrin lotion (49 participants)
Both medications applied as a single application |
|
| | Outcomes | 1. Number of participants with absence of lesions at 28 days
2. Number of participants with persistence of pruritus at 28 days
3. Adverse events
Not included in this review:
4. Number of participants with absence of lesions at 14 days |
|
| | Notes | Location: not stated
Date: not stated
Data taken from a conference abstract |
|
|
Ly 2009
|
| Methods | Design: randomized controlled trial
Generation of allocation sequence: random number table
Allocation concealment: unclear
Blinding: none
Inclusion of randomized participants in the analysis: 90% (19/181 lost to follow up) |
|
| | Participants | Number: 181 enrolled (mean age 16.5 years; 116 males, 65 females)
Inclusion criteria: clinical diagnosis of scabies
Exclusion criteria: pruritus due to insect bites; chickenpox in participant or member of participant's family; treatment for scabies within previous month; under 5 years or over 65 years of age; weight less than 15 kg; pregnancy; breastfeeding; use of bleaching products for cosmetic purposes; crusted scabies; diabetes; hypertension; cardiovascular disease; neurological disease; living outside of Dakar district |
|
| | Interventions | 1. Oral ivermectin 150-200 µg/kg bodyweight single dose (65 participants)
2. 12.5% benzyl benzoate to whole body except head (single application left on for 24 hours, 68 participants; two consecutive 24 hour applications, 48 participants)
Not included in this review
4. Second dose of oral ivermectin at 14 days for treatment failures in intervention group 1 (ivermectin)
5. Second single application of 12.5% benzyl benzoate at 14 days for treatment failures in intervention group 2 (benzyl benzoate single application)
6. Second double application of 12.5% benzyl benzoate at 14 days for treatment failures in intervention group 3 (benzyl benzoate double application) |
|
| | Outcomes | 1. Number of participants cured at 14 days (defined as complete disappearance of visible lesions and itching)
2. Adverse events
Not included in this review
3. Number of participants cured at 28 days
4. Number of participants with bacterial superinfection
5. Compliance with medication regimen |
|
| | Notes | Location: Dakar, Senegal
Date: July 2003 to September 2004 |
|
|
Macotela-Ruiz 1993
|
| Methods | Design: randomized controlled trial
Generation of allocation sequence: unclear
Allocation concealment: unclear
Blinding: participants and outcomes assessor
Inclusion of randomized participants in the analysis: 100% |
|
| | Participants | Number: 55 enrolled (aged over 5 years;18 males mean age 25 +/- 4 years, 37 females mean age 24 +/- 16 years)
Inclusion criteria: clinical diagnosis of scabies
Exclusion criteria: pregnancy; breastfeeding; impaired renal function; impaired liver function; treatment for scabies within previous 3 weeks |
|
| | Interventions | 1. Oral ivermectin 200 µg/kg bodyweight single dose (29 participants)
2. Placebo (26 participants) |
|
| | Outcomes | 1. Number of participants clinically cured at 7 days (defined as absence of itching and no dermatologically active lesions)
2. Adverse events |
|
| | Notes | Location: Mexico
Date: not stated
Trial stopped at 7 days as ivermectin group significantly clinically better |
|
|
Madan 2001
|
| Methods | Design: randomized controlled trial
Generation of allocation sequence: unclear
Allocation concealment: unclear
Blinding: outcomes assessor
Inclusion of randomized participants in the analysis: 75% (50/200 lost to follow up) |
|
| | Participants | Number: 200 enrolled (aged over 5 years; 132 males, 68 females)
Inclusion criteria: clinical diagnosis of scabies (defined as nocturnal itching and/or family contact with similar complaint and/or typical lesions)
Exclusion criteria: pregnancy; breastfeeding; severe cardiovascular, respiratory, or central nervous system disorders |
|
| | Interventions | 1. Oral ivermectin 200 µg/kg bodyweight single dose (100 participants)
2. 1% lindane lotion applied neck to toe and left on overnight (100 participants) |
|
| | Outcomes | 1. Number of participants clinically cured at 4 weeks (defined as no signs or symptoms of scabies)
2. Adverse events
Not included in this review:
3. Number of participants clinically cured at 2 weeks
4. Number of patients with good improvement at 4 weeks |
|
| | Notes | Location: India
Date: not stated
Microscopic confirmation of diagnosis in 170/200 (85%) of participants
Family contacts treated with 25% benzyl benzoate lotion for 3 days |
|
|
Maggi 1986
|
| Methods | Design: randomized controlled trial
Generation of allocation sequence: "randomly selected"
Allocation concealment: unclear
Blinding: unclear
Inclusion of randomized participants in the analysis: 100% |
|
| | Participants | Number: 87 enrolled (children, age range not stated)
Inclusion criteria: scabies, not further explained
Exclusion criteria: pyodermatitis |
|
| | Interventions | 1. 1% lindane suspension applied topically from chin to feet; 2 x 1-h applications 7 days apart (45 participants)
2. 1% lindane suspension applied topically from chin to feet; 2 series of 4 daily applications, 7 days apart (42 participants) |
|
| | Outcomes | 1. Number of participants with absence of pruritus at 14 days
Not included in this review:
2. Number of participants with absence of pruritus at 7 days
3. Numbers of participants with excoriations or burrows at days 7 and 14 |
|
| | Notes | Location: Chile
Date: March to November 1985 |
|
|
Nnoruka 2001
|
| Methods | Design: randomized controlled trial
Generation of allocation sequence: random-number table
Allocation concealment: unclear
Blinding: unclear
Inclusion of randomized participants in the analysis: 100% |
|
| | Participants | Number: 58 enrolled (aged 5 to 63 years, mean 27.9 years; 35 males, 33 females)
Inclusion criteria: clinically diagnosed scabies (microbiologically confirmed in 43/58)
Exclusion criteria: aged < 5 years |
|
| | Interventions | 1. Oral ivermectin 200 µg/kg bodyweight single dose (29 participants)
2. 25% benzyl benzoate emulsion applied neck to toe and left for 72 h (29 participants) |
|
| | Outcomes | 1. Number of participants clinically cured at 30 days (defined as complete disappearance of initial lesions and pruritus)
2. Adverse events
Not included in this review:
3. Number of participants clinically cured at 7 days
4. Number of participants clinically cured at 14 days
5. Response of pruritus (graded on subjective scale) at 7, 14, and 30 days
6. Mean clinical score (based on number and activity of lesions) |
|
| | Notes | Location: Nigeria
Date: June 1998
All household contacts treated at same time as the participant (treatment not stated) |
|
|
Schenone 1986
|
| Methods | Design: randomized controlled trial
Generation of allocation sequence: unclear
Allocation concealment: unclear
Blinding: unclear
Inclusion of randomized participants in the analysis: 100% |
|
| | Participants | Number: 127 enrolled (aged 4 to 19 years; 53 males, 74 females)
Inclusion criteria: clinical diagnosis of scabies
Exclusion criteria: none stated |
|
| | Interventions | 1. 40 mL of 0.02% decamethrin lotion, applied everywhere except skull and face, daily for 2 days, and repeated on 2 more days 1 week later (53 participants)
2. 40 mL of 0.02% decamethrin lotion, applied everywhere except skull and face, daily for 4 days (74 participants) |
|
| | Outcomes | 1. Number of participants clinically cured at 21 days (defined as no active lesions) |
|
| | Notes | Location: Chile (18 boarding schools in Santiago)
Date: 1985
Prevalence amongst boarding school children (aged 4 to 19): 127/868 (14.6%)
Contacts treated with single dose of 0.02% decamethrin |
|
|
Schultz 1990
|
| Methods | Design: randomized controlled trial
Generation of allocation sequence: unclear
Allocation concealment: medication supplied to each trial centre in identical coded boxes
Blinding: outcomes assessor
Inclusion of randomized participants in the analysis: 87% (63/467 participants not analysed (for primary outcome)) |
|
| | Participants | Number: 467 enrolled (aged 2 months to 75 years, mean age 22.1 years; 297 males, 170 females)
Inclusion criteria: clinical diagnosis of scabies
Exclusion criteria: pregnancy; breastfeeding; treatment with ectoparasiticide within previous 3 weeks; renal impairment; hepatic impairment; known allergy to permethrin or lindane |
|
| | Interventions | 1. 5% permethrin cream applied to entire body below ears, single application (234 participants)
2. 1% lindane lotion applied from neck down, single application (233 participants) |
|
| | Outcomes | 1. Number of participants clinically cured at 28 +/- 7 days (defined as all original lesions healed and no new lesions)
2. Number of participants with persistence of itch
3. Adverse events
Not included in this review:
4. Number of participants clinically cured at 14 +/- 3 days
5. Number of microbiologically confirmed cases clinically cured |
|
| | Notes | Location: USA and Mexico (4 sexually transmitted diseases clinics, 2 dermatology clinics, and 2 family practice clinics, 1 of which was in Mexico and all others in USA)
Date: not stated
Personal contacts of 85% of participants provided with 1% lindane for their use
Study supported in part by a grant from Burroughs Wellcome (manufacturers of permethrin) who also provided statistical assistance |
|
|
Singalavanija 2003
|
| Methods | Design: randomized controlled trial
Generation of allocation sequence: random-number table
Allocation concealment: unclear
Blinding: unclear
Inclusion of randomized participants in the analysis: 68% (32/100 participants lost to follow up) |
|
| | Participants | Number: 100 enrolled (aged 6 months to 13 years; 60 males, 40 females)
Inclusion criteria: clinically diagnosed and microbiologically confirmed scabies
Exclusion criteria: resident in an orphanage; serious central nervous system illness; malnutrition; immunodeficiency |
|
| | Interventions | 1. 10% sulfur ointment (50 participants)
2. 0.3% lindane gel (50 participants)
Both medications applied neck to toe by parents for 7 consecutive nights |
|
| | Outcomes | 1. Number of participants clinically cured (no new lesions and healing of all old lesions) at 4 weeks
2. Number of participants with decrease or absence of itching at 4 weeks
3. Adverse events
Not included in this review:
4. Number of participants clinically cured at 2 weeks (defined as no new lesions and healing of all old lesions)
5. Number of participants with decrease or absence of itching at 2 weeks
6. Number of participants with absence of parasites on skin scraping at 2 and 4 weeks |
|
| | Notes | Location: Thailand
Date: December 1999 to May 2000
Contacts treated with either 25% benzyl benzoate (adults) or 10% sulfur (children) |
|
|
Taplin 1986
|
| Methods | Design: randomized controlled trial
Generation of allocation sequence: "randomized code"
Allocation concealment: identical coded medication tubes; codes held by sponsor
Blinding: investigators
Inclusion of randomized participants in the analysis: 98% (1/52 participant lost to follow up) |
|
| | Participants | Number: 52 enrolled (aged 2 to 40 years, mean age 9 years; 22 males, 29 females, 1 gender not stated)
Inclusion criteria: clinically diagnosed scabies (confirmed microscopically in 46/52 cases)
Exclusion criteria: unwell; febrile; taking any medication; treatment with pediculicides, scabicides, or other topical agent in previous 3 months |
|
| | Interventions | 1. 5% permethrin cream (27 participants)
2. 1% lindane lotion (25 participants)
Both medications applied as a single application head to toe |
|
| | Outcomes | 1. Number of participants with no new lesions and healing of all original lesions at 1 month
2. Adverse events
Not included in this review:
3. Number of participants with no new lesions and healing of all original lesions at 2 weeks |
|
| | Notes | Location: Panama
Date: not stated
All family contacts treated with 1% lindane lotion
Photographs taken before and after treatment and distribution of any lesions noted on diagrams
Study supported in part by a grant from Burroughs Wellcome (manufacturers of permethrin) |
|
|
Taplin 1990
|
| Methods | Design: randomized controlled trial
Generation of allocation sequence: unclear
Allocation concealment: "medications supplied in identical ... tubes that were coded and randomized"
Blinding: investigators
Inclusion of randomized participants in the analysis: 98% (2/96 participants lost to follow up) |
|
| | Participants | Number: 96 enrolled (aged 2 months to 5 years; 42 males, 54 females)
Inclusion criteria: clinical diagnosis and the recovery of at least 1 live mite
Exclusion criteria: none stated |
|
| | Interventions | 1. 10% crotamiton cream (48 participants)
2. 5% permethrin cream (48 participants)
Both medications applied as single application from head to toe and left for 8 to 10 h |
|
| | Outcomes | 1. Number of participants with no new lesions and all original active lesions healed at 28 days
2. Number of participants with persistence of pruritus at 28 days
3. Adverse events
Not included in this review:
4. Number of participants with no new lesions and all original active lesions healed at 14 days
5. Number of participants with persistence of pruritus at 14 days |
|
| | Notes | Location: Panama
Date: 1985
Household contacts were treated with 5% permethrin cream
65/96 (68%) participants had secondary cutaneous infection
Study supported in part by a grant from Burroughs Wellcome (manufacturers of permethrin) |
|
|
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% |
|
| | 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 |
|
| | 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) |
|
| | 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 |
|
| | 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 |
|
|
Zargari 2006
|
| Methods | Design: randomized controlled trial
Generation of allocation sequence: unclear
Allocation concealment: "drugs ... packaged in identical appearing tubes and randomized and coded by the manufacturer"
Blinding: participants and investigators
Inclusion of randomized participants in the analysis: 84.6% (18/117 lost to follow up) |
|
| | Participants | Number: 117 enrolled (aged 6 to 64 years, mean age 30.2 years +/- 15.3; 55 males and 44 females followed up)
Inclusion criteria: clinically diagnosed scabies (defined as burrow or typical lesions at classical sites plus nocturnal pruritus plus similar symptoms in contacts) and/or microscopically diagnosed scabies (demonstration of egg, larvae, mite, or faecal material)
Exclusion criteria: < 5 years of age; treatment with antiscabietic medication or topical steroid in previous 4 weeks; pregnancy; breastfeeding; severe central nervous system, hepatic, or renal problems |
|
| | Interventions | 1. 5% permethrin cream (59 participants)
2. 1% lindane cream (58 participants)
Both medications applied as a single application head to toe, and repeated 1 week later |
|
| | Outcomes | 1. Number of participants with no new lesions and improvement in itching at 14 days
2. Adverse events |
|
| | Notes | Location: Iran
Date: December 2002 to October 2003
Treatment advised for all family members and close contacts
Study supported by Gilaranco Company (manufacturers of permethrin and lindane) |
|
|
Characteristics of excluded studies [ordered by study ID]
|
| Study | Reason for exclusion |
|---|
| | Abedin 2007 | Non-randomized study |
| | Alebiosu 2003 | Allocation method inadequate; expressed preference of participants for different interventions taken into account |
| | Amer 1981 | Non-randomized study |
| | Bockarie 2000 | Non-controlled study |
| | Burgess 1986 | Non-randomized study |
| | Cannon 1948 | Non-controlled study |
| | Chowdhury 1977 | Non-controlled study |
| | Cubela 1978 | Non-randomized study |
| | Curiati 1984 | Non-randomized study |
| | Damodaran 1979 | A trial of iron and folic acid supplementation |
| | Daneshpajooh 2000 | Unclear if randomized |
| | Dika 2006 | Non-controlled study |
| | Dourmishev 1998 | Non-controlled study |
| | Dunne 1991 | Study participants selected on basis of having onchocerciasis rather than scabies |
| | Gallegos 1996 | Thesis unavailable |
| | Gordon 1944 | Non-randomized study |
| | Grabner 1970 | Non-randomized study |
| | Hamm 2006 | Non-controlled study |
| | Hanna 1978 | Non-controlled study |
| | Haustein 1989 | Non-randomized study |
| | Henderson 1991 | Non-randomized study |
| | Henderson 1992 | Non-randomized study |
| | Kar 1994 | Case study |
| | Kaur 1980 | Non-randomized study |
| | Kenawi 1993 | Non-randomized study |
| | Khan 2007 | Non-randomized study |
| | Konstantinov 1979 | Non-randomized study |
| | Landegren 1979 | Non-randomized study |
| | López 2003 | Non-randomized study |
| | Macotela-Ruiz 1996 | Not truly randomized; unbalanced groups |
| | Mapar 2008 | Non-randomized study |
| | Meinking 1995b | Non-controlled study |
| | Mellanby 1945 | Non-randomized study |
| | Mozgunov 1978 | Non-controlled study |
| | Nag 1995 | Non-randomized study |
| | Neto 1984 | Non-randomized study |
| | Oberoi 2007 | Non-randomized study; cure not assessed |
| | Oladimeji 2000 | Participants randomized to 1 of 3 treatments (lippia oil, benzyl benzoate, or liquid paraffin) but no clear randomization within these groups to 36 separate treatment schedule subgroups |
| | Oladimeji 2005 | Trial design inadequate with control group consisting of participants excluded from intervention arms |
| | Oyelami 2009 | Non-controlled study |
| | Paasch 2000 | Non-randomized study |
| | Paschoal 1985 | Not a trial of scabies treatment effectiveness |
| | Pierce 1951 | Non-randomized study |
| | Regis 2003 | Outcome is reinfestation not treatment failure |
| | Reid 1990 | Non-controlled study |
| | Sehgal 1972 | No assessment of any outcomes were reported |
| | Srinivas 1996 | Randomization unclear; comparison of lindane applied by bath, paint brush, and spray |
| | Srivastava 1980 | Allocation made on a "random basis and on availability of drugs" |
| | Sule 2007 | Non-randomized study |
| | Suvanprakorn 1987 | Non-controlled study |
| | Taplin 1983a | Non-randomized study |
| | Taplin 1983b | Non-controlled study |
| | Taplin 1991 | Non-controlled study |
| | Tausch 1999 | Comparison between 2 different brands of the same drug (10% crotamiton lotion) |
| | Thianprasit 1984 | Non-controlled study |
| | Woolridge 1948 | Non-controlled study |
| | Yonkonsky 1990 | Non-controlled study |
|
|
Characteristics of ongoing studies [ordered by study ID]
Naeyaert ongoing
|
| Trial name or title | "A randomised, double blind, double dummy study to compare the efficacy and safety of a single administration of ivermectin to a single administration of permethrin for the treatment of scabies" |
| | Methods | — |
| | Participants | Expected enrolment: 160
Minimum age: 5 years
Both genders
Inclusion criteria: at least 1 of scabies tunnels or positive microscopic examination (acarids, faeces, or ova); at least two of non-specific injuries with a typical distribution pattern, serious itching which increases during the night, or family or contacts with similar complaints
Exclusion criteria: treatment for scabies < 4 weeks ago; treatment with corticoids < 1 week ago; pregnancy; breastfeeding; HIV; serious immunodepressive patients; sensitivity or allergy to 1 of the components of the study medication; damage of the central nerve system |
| | Interventions | Administration of ivermectin or permethrin on day 0 |
| | Outcomes | Primary: clinical healing of the skin injuries on day 28
Secondary: decrease of itching on day 28; amelioration of the life quality on day 28; number and gravity of adverse events |
| | Starting date | July 2004 |
| | Contact information | Jean-Marie Naeyaert, Principal Investigator, University Hospital Ghent, Ghent 9000, Belgium |
| | Notes | ClinicalTrials.gov identifier: NCT00262418 |
|
|
Comparison 1. Ivermectin versus placebo
Comparison 2. Ivermectin versus permethrin
Comparison 3. Ivermectin versus lindane
Comparison 4. Ivermectin versus benzyl benzoate
|
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|
| | 1 Treatment failure in clinically diagnosed cases | 5 | | Risk Ratio (M-H, Fixed, 95% CI) | Totals not selected |
| | | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Not estimable |
| | | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Not estimable |
| | | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Not estimable |
| | | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Not estimable |
| | | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Not estimable |
| | 2 Itch persistence | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Totals not selected |
| | | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Not estimable |
|
|
Comparison 5. Permethrin versus crotamiton
|
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|
| | 1 Treatment failure in clinically diagnosed cases | 2 | | Risk Ratio (M-H, Fixed, 95% CI) | Subtotals only |
| | | 2 | 194 | Risk Ratio (M-H, Fixed, 95% CI) | 0.24 [0.10, 0.55] |
| | 2 Treatment failure in microscopically diagnosed cases | 2 | | Risk Ratio (M-H, Fixed, 95% CI) | Subtotals only |
| | | 2 | 194 | Risk Ratio (M-H, Fixed, 95% CI) | 0.24 [0.10, 0.55] |
| | 3 Itch persistence | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Totals not selected |
| | | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Not estimable |
|
|
Comparison 6. Permethrin versus lindane
|
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|
| | 1 Treatment failure in clinically diagnosed cases | 5 | | Risk Ratio (M-H, Fixed, 95% CI) | Subtotals only |
| | | 1 | 99 | Risk Ratio (M-H, Fixed, 95% CI) | 0.15 [0.06, 0.40] |
| | | 1 | 100 | Risk Ratio (M-H, Fixed, 95% CI) | 0.08 [0.01, 0.57] |
| | | 3 | 554 | Risk Ratio (M-H, Fixed, 95% CI) | 0.59 [0.37, 0.95] |
| | 2 Treatment failure in microscopically diagnosed cases | 3 | | Risk Ratio (M-H, Fixed, 95% CI) | Subtotals only |
| | | 2 | 384 | Risk Ratio (M-H, Fixed, 95% CI) | 0.57 [0.32, 1.02] |
| | | 1 | 100 | Risk Ratio (M-H, Fixed, 95% CI) | 0.08 [0.01, 0.57] |
| | 3 Itch persistence | 2 | | Risk Ratio (M-H, Fixed, 95% CI) | Subtotals only |
| | | 2 | 490 | Risk Ratio (M-H, Fixed, 95% CI) | 0.61 [0.44, 0.86] |
|
|
Comparison 7. Permethrin versus benzyl benzoate
Comparison 8. Permethrin versus natural synergized pyrethrins
|
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|
| | 1 Itch persistence | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Totals not selected |
| | | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Not estimable |
|
|
Comparison 9. Crotamiton versus lindane
Comparison 10. Lindane versus sulfur
|
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|
| | 1 Treatment failure in clinically diagnosed cases | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Totals not selected |
| | | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Not estimable |
| | 2 Itch persistence | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Totals not selected |
| | | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Not estimable |
|
|
Comparison 11. Benzyl benzoate versus sulfur
Comparison 12. Benzyl benzoate versus natural synergized pyrethrins
|
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|
| | 1 Treatment failure in clinically diagnosed cases | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Totals not selected |
| | | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Not estimable |
| | 2 Treatment failure in microscopically diagnosed cases | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Totals not selected |
| | | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Not estimable |
| | 3 Itch persistence | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Totals not selected |
| | | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Not estimable |
|
|
Comparison 13. Benzyl benzoate: one application versus two applications
Comparison 14. Lindane: short application versus long application
|
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|
| | 1 Itch persistence | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Totals not selected |
| | | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Not estimable |
|
|
Comparison 15. Sulfur: pork fat vehicle versus cold cream vehicle
Table 1. Quality assessment
|
| |
|
aInclusion of randomized participants in analysis.
|
Table 2. Adverse events
|
| Comparison | Trial | Adverse event | Intervention | n/Na | Intervention | n/Na |
| | Ivermectin vs placebo | Macotela-Ruiz 1993 | None recorded | Ivermectin | — | Placebo | — |
| | Ivermectin vs permethrin | Usha 2000 | Aggravation of symptoms | Ivermectin | 3/43 | Permethrin | 0/45 |
| | Bachewar 2009 | None recorded | Ivermectin | — | Permethrin | — |
| | Ivermectin vs lindane | Chouela 1999 | Headache | Ivermectin | 1/26 | Lindane | 6/27 |
| | Headache | Ivermectin | 1/26 | Lindane | 0/27 |
| | Hypotension | Ivermectin | 1/26 | Lindane | 0/27 |
| | Abdominal pain | Ivermectin | 1/26 | Lindane | 0/27 |
| | Vomiting | Ivermectin | 1/26 | Lindane | 0/27 |
| | Madan 2001 | Severe headache | Ivermectin | 1/100 | Lindane | 0/100 |
| | Ivermectin vs benzyl benzoate | Glaziou 1993 | Mild increase in pruritus | Ivermectin | 0/23 | Benzyl benzoate | 5/21 |
| | Nnoruka 2001 | Pruritus and irritation | Ivermectin | 0/29 | Benzyl benzoate | 7/29 |
| | Brooks 2002 | Pustular rash | Ivermectin | 3/43 | Benzyl benzoate | 0/37 |
| | Cellulitis | Ivermectin | 1/43 | Benzyl benzoate | 0/37 |
| | Burning or stinging | Ivermectin | 0/43 | Benzyl benzoate | 6/37 |
| | Dermatitis | Ivermectin | 0/43 | Benzyl benzoate | 6/37 |
| | Bachewar 2009 | None recorded | Ivermectin | — | Benzyl benzoate | — |
| | Ly 2009 | Abdominal pain | Ivermectin | 5/65 | Benzyl benzoate | 0/116 |
| | Mild diarrhoea | Ivermectin | 2/65 | Benzyl benzoate | 0/116 |
| | Irritant dermatitis | Ivermectin | 0/65 | Benzyl benzoate | 30/116 |
| | Permethrin vs crotamiton | Taplin 1990 | Worsening of symptoms | Permethrin | 0/48 | Crotamiton | 10/48 |
| | Amer 1992 | None recorded | Permethrin | — | Crotamiton | — |
| | Permethrin vs lindane | Hansen 1986 | Mild burning, stinging, or itching | Permethrin | 5/49 | Lindane | 5/50 |
| | Taplin 1986 | None recorded | Permethrin | — | Lindane | — |
| | Schultz 1990 | Burning/stinging | Permethrin | 23/234 | Lindane | 12/233 |
| | Pruritus | Permethrin | 15/234 | Lindane | 17/233 |
| | Erythema | Permethrin | 5/234 | Lindane | 3/233 |
| | Tingling | Permethrin | 4/234 | Lindane | 5/233 |
| | Rash | Permethrin | 2/234 | Lindane | 2/233 |
| | Diarrhoea | Permethrin | 1/234 | Lindane | 1/233 |
| | Persistent excoriation | Permethrin | 1/234 | Lindane | 0/233 |
| | Contact dermatitis | Permethrin | 0/234 | Lindane | 1/233 |
| | Phemphigus | Permethrin | 0/234 | Lindane | 1/233 |
| | Papular rash | Permethrin | 0/234 | Lindane | 1/233 |
| | Amer 1992 | None recorded | Permethrin | — | Lindane | — |
| | Zargari 2006 | Skin irritation | Permethrin | 2/59 | Lindane | 1/58 |
| | Permethrin versus benzyl benzoate | Bachewar 2009 | None recorded | Permethrin | — | Benzyl benzoate | — |
| | Permethrin vs synergized natural pyrethrins | Amerio 2003 | Secondary skin infection | Permethrin | 10/20 | Synergized pyrethrins | 2/20 |
| | Crotamiton vs lindane | Amer 1992 | None recorded | Lindane | — | Crotamiton | — |
| | Lindane vs sulfur | Singalavanija 2003 | Foul odour | Lindane | 3/50 | Sulfur | 10/50 |
| | Burning | Lindane | 6/50 | Sulfur | 2/50 |
| | Erythema | Lindane | 5/50 | Sulfur | 2/50 |
| | Benzyl benzoate vs sulfur | Gulati 1978 | None recorded | Benzyl benzoate | — | Sulfur | — |
| | Benzyl benzoate vs synergized natural pyrethrins | Biele 2006 | Skin irritation and burning sensations | Benzyl benzoate | 22/120 | Synergized pyrethrins | 3/120 |
| | Lindane: short vs long application | Maggi 1986 | None recorded | Lindane (short course) | — | Lindane (long course) | — |
| | Decamethrin: 2-day + 2-day vs 4-day application | Schenone 1986 | Moderate skin hotness | Decamethrin (both regimens) | 15/127 |
|
|
|
|
| | Sulfur: pork fat vehicle vs cold cream vehicle | Avila-Romay 1991 | Pruritus | Sulfur/salicylic acid in pork fat | 32/53 | Sulfur in cold cream | 18/58 |
| | Xerosis | Sulfur/salicylic acid in pork fat | 18/53 | Sulfur in cold cream | 14/58 |
| | Burning sensations | Sulfur/salicylic acid in pork fat | 9/53 | Sulfur in cold cream | 6/58 |
| | Keratosis pilaris | Sulfur/salicylic acid in pork fat | 8/53 | Sulfur in cold cream | 0/58 |
| | Erythema | Sulfur/salicylic acid in pork fat | 1/53 | Sulfur in cold cream | 6/58 |
| | Keratosis follicularis | | 0/53 | Sulfur in cold cream | 1/58 |
|
|
aNo. participants reporting event/total no. participants.
|
