Intervention Review

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Interventions for treating scabies

  1. Mark Strong1,*,
  2. Paul Johnstone2

Editorial Group: Cochrane Infectious Diseases Group

Published Online: 18 JUL 2007

Assessed as up-to-date: 10 AUG 2010

DOI: 10.1002/14651858.CD000320.pub2


How to Cite

Strong M, Johnstone P. Interventions for treating scabies. Cochrane Database of Systematic Reviews 2007, Issue 3. Art. No.: CD000320. DOI: 10.1002/14651858.CD000320.pub2.

Author Information

  1. 1

    University of Sheffield, School of Health and Related Research, Sheffield, UK

  2. 2

    Blenheim House, NHS Yorkshire and the Humber, Leeds, UK

*Mark Strong, School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK. m.strong@sheffield.ac.uk.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 18 JUL 2007

SEARCH

 
Characteristics of included studies [ordered by study ID]
Amer 1992

MethodsDesign: randomized controlled trial

Generation of allocation sequence: "according to code"

Allocation concealment: unclear

Blinding: unclear

Inclusion of randomized participants in the analysis: 100%


ParticipantsNumber: 150 enrolled (all ages; sex not stated)

Inclusion criteria: clinically diagnosed and microbiologically confirmed scabies

Exclusion criteria: significant impetiginization


Interventions1. 5% permethrin (50 participants)
2. 10% crotamiton (50 participants)
3. 1% lindane (50 participants)

Each medication applied "neck to toe" on 2 successive nights


Outcomes1. Number of participants clinically cured (no new lesions and all original lesions healed) at 28 days


NotesLocation: Egypt

Date: not stated

Colour photographs used for comparison before and after treatment

Amerio 2003

MethodsDesign: 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%


ParticipantsNumber: 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


Interventions1. 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


Outcomes1. 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


NotesLocation: Italy

Date: March 2001 to October 2001

Trial supported by unrestricted grant from Mipharm SpA

Avila-Romay 1991

MethodsDesign: randomized controlled trial

Generation of allocation sequence: "randomly assigned"

Allocation concealment: unclear

Blinding: unclear

Inclusion of randomized participants in the analysis: 100%


ParticipantsNumber: 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


Interventions1. 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


Outcomes1. 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)


NotesLocation: 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

MethodsDesign: 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)


ParticipantsNumber: 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.


Interventions1. 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)


Outcomes1. 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


NotesLocation: 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

MethodsDesign: randomized controlled trial

Generation of allocation sequence: computer generated

Allocation concealment: unclear

Blinding: investigators

Inclusion of randomized participants in the analysis: 100%


ParticipantsNumber: 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


Interventions1. 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


Outcomes1. 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


NotesLocation: Italy

Date: October 2003 to July 2004

Brooks 2002

MethodsDesign: 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)


ParticipantsNumber: 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


Interventions1. Oral ivermectin 200 µg/kg bodyweight single dose (55 participants)
2. 10% benzyl benzoate applied neck to toe overnight (55 participants)


Outcomes1. 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


NotesLocation: 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

MethodsDesign: 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)


ParticipantsNumber: 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


Interventions1. 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)


Outcomes1. 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


NotesLocation: 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

MethodsDesign: randomized controlled trial

Generation of allocation sequence: "randomly allocated"

Allocation concealment: unclear

Blinding: outcomes assessor

Inclusion of randomized participants in the analysis: 100%


ParticipantsNumber: 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


Interventions1. 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)


Outcomes1. 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)


NotesLocation: 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

MethodsDesign: randomized controlled trial

Generation of allocation sequence: "cases ... divided at random"

Allocation concealment: unclear

Blinding: unclear

Inclusion of randomized participants in the analysis: 100%


ParticipantsNumber: 158 enrolled (mean age 16.6 years; 75 males, 83 females)

Inclusion criteria: clinical diagnosis of scabies

Exclusion criteria: none stated


Interventions1. 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


Outcomes1. 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


NotesLocation: 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

MethodsDesign: 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)


ParticipantsNumber: 104 enrolled (aged 2 to 71 years)

Inclusion criteria: clinical and/or microscopic diagnosis of scabies

Exclusion criteria: none stated


Interventions1. 1% lindane lotion (50 participants)
2. 5% permethrin lotion (49 participants)

Both medications applied as a single application


Outcomes1. 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


NotesLocation: not stated

Date: not stated

Data taken from a conference abstract

Ly 2009

MethodsDesign: 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)


ParticipantsNumber: 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


Interventions1. 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)


Outcomes1. 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


NotesLocation: Dakar, Senegal

Date: July 2003 to September 2004

Macotela-Ruiz 1993

MethodsDesign: randomized controlled trial

Generation of allocation sequence: unclear

Allocation concealment: unclear

Blinding: participants and outcomes assessor

Inclusion of randomized participants in the analysis: 100%


ParticipantsNumber: 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


Interventions1. Oral ivermectin 200 µg/kg bodyweight single dose (29 participants)
2. Placebo (26 participants)


Outcomes1. Number of participants clinically cured at 7 days (defined as absence of itching and no dermatologically active lesions)
2. Adverse events


NotesLocation: Mexico

Date: not stated

Trial stopped at 7 days as ivermectin group significantly clinically better

Madan 2001

MethodsDesign: 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)


ParticipantsNumber: 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


Interventions1. Oral ivermectin 200 µg/kg bodyweight single dose (100 participants)
2. 1% lindane lotion applied neck to toe and left on overnight (100 participants)


Outcomes1. 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


NotesLocation: 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

MethodsDesign: randomized controlled trial

Generation of allocation sequence: "randomly selected"

Allocation concealment: unclear

Blinding: unclear

Inclusion of randomized participants in the analysis: 100%


ParticipantsNumber: 87 enrolled (children, age range not stated)

Inclusion criteria: scabies, not further explained

Exclusion criteria: pyodermatitis


Interventions1. 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)


Outcomes1. 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


NotesLocation: Chile

Date: March to November 1985

Nnoruka 2001

MethodsDesign: randomized controlled trial

Generation of allocation sequence: random-number table

Allocation concealment: unclear

Blinding: unclear

Inclusion of randomized participants in the analysis: 100%


ParticipantsNumber: 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


Interventions1. 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)


Outcomes1. 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)


NotesLocation: Nigeria

Date: June 1998

All household contacts treated at same time as the participant (treatment not stated)

Schenone 1986

MethodsDesign: randomized controlled trial

Generation of allocation sequence: unclear

Allocation concealment: unclear

Blinding: unclear

Inclusion of randomized participants in the analysis: 100%


ParticipantsNumber: 127 enrolled (aged 4 to 19 years; 53 males, 74 females)

Inclusion criteria: clinical diagnosis of scabies

Exclusion criteria: none stated


Interventions1. 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)


Outcomes1. Number of participants clinically cured at 21 days (defined as no active lesions)


NotesLocation: 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

MethodsDesign: 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))


ParticipantsNumber: 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


Interventions1. 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)


Outcomes1. 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


NotesLocation: 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

MethodsDesign: 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)


ParticipantsNumber: 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


Interventions1. 10% sulfur ointment (50 participants)
2. 0.3% lindane gel (50 participants)

Both medications applied neck to toe by parents for 7 consecutive nights


Outcomes1. 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


NotesLocation: Thailand

Date: December 1999 to May 2000

Contacts treated with either 25% benzyl benzoate (adults) or 10% sulfur (children)

Taplin 1986

MethodsDesign: 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)


ParticipantsNumber: 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


Interventions1. 5% permethrin cream (27 participants)
2. 1% lindane lotion (25 participants)

Both medications applied as a single application head to toe


Outcomes1. 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


NotesLocation: 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

MethodsDesign: 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)


ParticipantsNumber: 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


Interventions1. 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


Outcomes1. 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


NotesLocation: 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

MethodsDesign: 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%


ParticipantsNumber: 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


Interventions1. 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)


Outcomes1. 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


NotesLocation: 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

MethodsDesign: 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)


ParticipantsNumber: 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


Interventions1. 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


Outcomes1. Number of participants with no new lesions and improvement in itching at 14 days
2. Adverse events


NotesLocation: 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]

StudyReason for exclusion

Abedin 2007Non-randomized study

Alebiosu 2003Allocation method inadequate; expressed preference of participants for different interventions taken into account

Amer 1981Non-randomized study

Bockarie 2000Non-controlled study

Burgess 1986Non-randomized study

Cannon 1948Non-controlled study

Chowdhury 1977Non-controlled study

Cubela 1978Non-randomized study

Curiati 1984Non-randomized study

Damodaran 1979A trial of iron and folic acid supplementation

Daneshpajooh 2000Unclear if randomized

Dika 2006Non-controlled study

Dourmishev 1998Non-controlled study

Dunne 1991Study participants selected on basis of having onchocerciasis rather than scabies

Gallegos 1996Thesis unavailable

Gordon 1944Non-randomized study

Grabner 1970Non-randomized study

Hamm 2006Non-controlled study

Hanna 1978Non-controlled study

Haustein 1989Non-randomized study

Henderson 1991Non-randomized study

Henderson 1992Non-randomized study

Kar 1994Case study

Kaur 1980Non-randomized study

Kenawi 1993Non-randomized study

Khan 2007Non-randomized study

Konstantinov 1979Non-randomized study

Landegren 1979Non-randomized study

López 2003Non-randomized study

Macotela-Ruiz 1996Not truly randomized; unbalanced groups

Mapar 2008Non-randomized study

Meinking 1995bNon-controlled study

Mellanby 1945Non-randomized study

Mozgunov 1978Non-controlled study

Nag 1995Non-randomized study

Neto 1984Non-randomized study

Oberoi 2007Non-randomized study; cure not assessed

Oladimeji 2000Participants 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 2005Trial design inadequate with control group consisting of participants excluded from intervention arms

Oyelami 2009Non-controlled study

Paasch 2000Non-randomized study

Paschoal 1985Not a trial of scabies treatment effectiveness

Pierce 1951Non-randomized study

Regis 2003Outcome is reinfestation not treatment failure

Reid 1990Non-controlled study

Sehgal 1972No assessment of any outcomes were reported

Srinivas 1996Randomization unclear; comparison of lindane applied by bath, paint brush, and spray

Srivastava 1980Allocation made on a "random basis and on availability of drugs"

Sule 2007Non-randomized study

Suvanprakorn 1987Non-controlled study

Taplin 1983aNon-randomized study

Taplin 1983bNon-controlled study

Taplin 1991Non-controlled study

Tausch 1999Comparison between 2 different brands of the same drug (10% crotamiton lotion)

Thianprasit 1984Non-controlled study

Woolridge 1948Non-controlled study

Yonkonsky 1990Non-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

ParticipantsExpected 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

InterventionsAdministration of ivermectin or permethrin on day 0

OutcomesPrimary: 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 dateJuly 2004

Contact informationJean-Marie Naeyaert, Principal Investigator, University Hospital Ghent, Ghent 9000, Belgium

NotesClinicalTrials.gov identifier: NCT00262418

 
Comparison 1. Ivermectin versus placebo

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Treatment failure in clinically diagnosed cases1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 200μg/kg Ivermectin vs placebo. Follow up at 7 days
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 2. Ivermectin versus permethrin

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Treatment failure in clinically diagnosed cases2Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 200μg/kg Ivermectin vs 5% Permethrin overnight.
2140Risk Ratio (M-H, Fixed, 95% CI)4.61 [2.07, 10.26]

 
Comparison 3. Ivermectin versus lindane

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Treatment failure in clinically diagnosed cases2Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 150-200μg/kg Ivermectin vs 1% Lindane.
2193Risk Ratio (M-H, Fixed, 95% CI)0.36 [0.23, 0.58]

 
Comparison 4. Ivermectin versus benzyl benzoate

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Treatment failure in clinically diagnosed cases5Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 200μg/kg Ivermectin vs 25% BB overnight x2. FU at 1 week
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.2 150-200μg/kg Ivermectin vs 12.5% BB 1 or 2 overnights. FU at 14 days
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.3 200μg/kg Ivermectin vs 10% BB overnight. FU at 3 weeks
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.4 100μg/kg Ivermectin vs 10% BB 3 x 12 hrs. FU at 30 days
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.5 200μg/kg Ivermectin vs 25% BB 72 hrs. FU at 30 days
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 Itch persistence1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 200μg/kg Ivermectin vs 10% BB overnight. FU at 3 weeks
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 5. Permethrin versus crotamiton

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Treatment failure in clinically diagnosed cases2Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 5% Permethrin vs 10% Crotamiton. FU at 28 days
2194Risk Ratio (M-H, Fixed, 95% CI)0.24 [0.10, 0.55]

 2 Treatment failure in microscopically diagnosed cases2Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    2.1 5% Permethrin vs 10% Crotamiton. FU at 28 days
2194Risk Ratio (M-H, Fixed, 95% CI)0.24 [0.10, 0.55]

 3 Itch persistence1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    3.1 5% Permethrin vs 10% Crotamiton. FU at 28 days
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 6. Permethrin versus lindane

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Treatment failure in clinically diagnosed cases5Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 5% Permethrin vs 1% Lindane single application repeated at 1 week. FU at 14 days
199Risk Ratio (M-H, Fixed, 95% CI)0.15 [0.06, 0.40]

    1.2 5% Permethrin vs 1% Lindane overnight x2. FU at 28 days
1100Risk Ratio (M-H, Fixed, 95% CI)0.08 [0.01, 0.57]

    1.3 5% Permethrin vs 1% Lindane single application. FU at 28 days
3554Risk Ratio (M-H, Fixed, 95% CI)0.59 [0.37, 0.95]

 2 Treatment failure in microscopically diagnosed cases3Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    2.1 5% Permethrin vs 1% Lindane single application. FU at 28 days
2384Risk Ratio (M-H, Fixed, 95% CI)0.57 [0.32, 1.02]

    2.2 5% Permethrin vs 1% Lindane overnight x2. FU at 28 days
1100Risk Ratio (M-H, Fixed, 95% CI)0.08 [0.01, 0.57]

 3 Itch persistence2Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    3.1 5% Permethrin vs 1% Lindane single application. FU at 28 days
2490Risk Ratio (M-H, Fixed, 95% CI)0.61 [0.44, 0.86]

 
Comparison 7. Permethrin versus benzyl benzoate

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Treatment failure in clinically diagnosed cases1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 5% Permethrin vs 25% BB overnight x2 FU at 1 week
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 8. Permethrin versus natural synergized pyrethrins

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Itch persistence1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 5% Permethrin vs 0.16% Pyrethrins for 8 hours x2. FU at 4 weeks
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 9. Crotamiton versus lindane

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Treatment failure in clinically diagnosed cases1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 10% Crotamiton vs 1% Lindane overnight x2. FU at 28 days
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 Treatment failure in microscopically diagnosed cases1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 10% Crotamiton vs 1% Lindane overnight x2. FU at 28 days
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 10. Lindane versus sulfur

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Treatment failure in clinically diagnosed cases1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 0.3% Lindane gel vs 10% Sulfur overnight x7. FU at 4 weeks
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 Itch persistence1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 0.3% Lindane gel vs 10% Sulfur overnight x7. FU at 4 weeks
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 11. Benzyl benzoate versus sulfur

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Treatment failure in clinically diagnosed cases1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 25% BB vs Sulfur ointment 3 applications. FU at 15 days
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 12. Benzyl benzoate versus natural synergized pyrethrins

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Treatment failure in clinically diagnosed cases1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 10% BB vs 0.16% Pyrethrins repeated after 2 weeks. FU at 4 weeks
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 Treatment failure in microscopically diagnosed cases1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 10% BB vs 0.16% Pyrethrins repeated after 2 weeks. FU at 4 weeks
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 3 Itch persistence1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    3.1 10% BB vs 0.16% Pyrethrins repeated after 2 weeks. FU at 4 weeks
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 13. Benzyl benzoate: one application versus two applications

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Treatment failure in clinically diagnosed cases1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 12.5% BB overnight x1 vs 12.5% BB overnight x2. FU at 14 days
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 14. Lindane: short application versus long application

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Itch persistence1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 1% Lindane 2x 1hr applications vs 2x 4 day applications. FU at 14 days
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 15. Sulfur: pork fat vehicle versus cold cream vehicle

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Treatment failure in clinically diagnosed cases1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 10% Sulfur in pork fat vs 10% Sulfur in cold cream. FU at 10 days
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Table 1. Quality assessment

TrialAllocation sequence generationAllocation concealmentBlindingInclusiona

Amer 1992UnclearUnclearUnclearAdequate

Amerio 2003AdequateAdequateInvestigatorsAdequate

Avila-Romay 1991UnclearUnclearUnclearAdequate

Bachewar 2009AdequateUnclearNoneInadequate

Biele 2006AdequateUnclearInvestigatorsAdequate

Brooks 2002AdequateUnclearInvestigatorsInadequate

Chouela 1999UnclearUnclearDescribed as "double blind"; participants blindedAdequate

Glaziou 1993UnclearUnclearOutcomes assessorAdequate

Gulati 1978UnclearUnclearUnclearAdequate

Hansen 1986UnclearUnclear"Single blind", unclear who was blindedAdequate

Ly 2009AdequateUnclearNoneAdequate

Macotela-Ruiz 1993UnclearUnclearParticipant and outcomes assessorAdequate

Madan 2001UnclearUnclearOutcomes assessorInadequate

Maggi 1986UnclearUnclearUnclearAdequate

Nnoruka 2001AdequateUnclearUnclearAdequate

Schenone 1986UnclearUnclearUnclearAdequate

Schultz 1990UnclearAdequateOutcomes assessorAdequate

Singalavanija 2003AdequateUnclearUnclearInadequate

Taplin 1986UnclearAdequateInvestigatorsAdequate

Taplin 1990UnclearAdequateInvestigatorsAdequate

Usha 2000AdequateAdequateNoneAdequate

Zargari 2006UnclearAdequateInvestigators and participantsAdequate

 aInclusion of randomized participants in analysis.
 
Table 2. Adverse events

ComparisonTrialAdverse eventInterventionn/NaInterventionn/Na

Ivermectin vs placeboMacotela-Ruiz 1993None recordedIvermectinPlacebo

Ivermectin vs permethrinUsha 2000Aggravation of symptomsIvermectin3/43Permethrin0/45

Bachewar 2009None recordedIvermectinPermethrin

Ivermectin vs lindaneChouela 1999HeadacheIvermectin1/26Lindane6/27

HeadacheIvermectin1/26Lindane0/27

HypotensionIvermectin1/26Lindane0/27

Abdominal painIvermectin1/26Lindane0/27

VomitingIvermectin1/26Lindane0/27

Madan 2001Severe headacheIvermectin1/100Lindane0/100

Ivermectin vs benzyl benzoateGlaziou 1993Mild increase in pruritusIvermectin0/23Benzyl benzoate5/21

Nnoruka 2001Pruritus and irritationIvermectin0/29Benzyl benzoate7/29

Brooks 2002Pustular rashIvermectin3/43Benzyl benzoate0/37

CellulitisIvermectin1/43Benzyl benzoate0/37

Burning or stingingIvermectin0/43Benzyl benzoate6/37

DermatitisIvermectin0/43Benzyl benzoate6/37

Bachewar 2009None recordedIvermectinBenzyl benzoate

Ly 2009Abdominal painIvermectin5/65Benzyl benzoate0/116

Mild diarrhoeaIvermectin2/65Benzyl benzoate0/116

Irritant dermatitisIvermectin0/65Benzyl benzoate30/116

Permethrin vs crotamitonTaplin 1990Worsening of symptomsPermethrin0/48Crotamiton10/48

Amer 1992None recordedPermethrinCrotamiton

Permethrin vs lindaneHansen 1986Mild burning, stinging, or itchingPermethrin5/49Lindane5/50

Taplin 1986None recordedPermethrinLindane

Schultz 1990Burning/stingingPermethrin23/234Lindane12/233

PruritusPermethrin15/234Lindane17/233

ErythemaPermethrin5/234Lindane3/233

TinglingPermethrin4/234Lindane5/233

RashPermethrin2/234Lindane2/233

DiarrhoeaPermethrin1/234Lindane1/233

Persistent excoriationPermethrin1/234Lindane0/233

Contact dermatitisPermethrin0/234Lindane1/233

PhemphigusPermethrin0/234Lindane1/233

Papular rashPermethrin0/234Lindane1/233

Amer 1992None recordedPermethrinLindane

Zargari 2006Skin irritationPermethrin2/59Lindane1/58

Permethrin versus benzyl benzoateBachewar 2009None recordedPermethrinBenzyl benzoate

Permethrin vs synergized natural pyrethrinsAmerio 2003Secondary skin infectionPermethrin10/20Synergized pyrethrins2/20

Crotamiton vs lindaneAmer 1992None recordedLindaneCrotamiton

Lindane vs sulfurSingalavanija 2003Foul odourLindane3/50Sulfur10/50

BurningLindane6/50Sulfur2/50

ErythemaLindane5/50Sulfur2/50

Benzyl benzoate vs sulfurGulati 1978None recordedBenzyl benzoateSulfur

Benzyl benzoate vs synergized natural pyrethrinsBiele 2006Skin irritation and burning sensationsBenzyl benzoate22/120Synergized pyrethrins3/120

Lindane: short vs long applicationMaggi 1986None recordedLindane (short course)Lindane (long course)

Decamethrin: 2-day + 2-day vs 4-day applicationSchenone 1986Moderate skin hotnessDecamethrin (both regimens)15/127





Sulfur: pork fat vehicle vs cold cream vehicleAvila-Romay 1991PruritusSulfur/salicylic acid in pork fat32/53Sulfur in cold cream18/58

XerosisSulfur/salicylic acid in pork fat18/53Sulfur in cold cream14/58

Burning sensationsSulfur/salicylic acid in pork fat9/53Sulfur in cold cream6/58

Keratosis pilarisSulfur/salicylic acid in pork fat8/53Sulfur in cold cream0/58

ErythemaSulfur/salicylic acid in pork fat1/53Sulfur in cold cream6/58

Keratosis follicularis0/53Sulfur in cold cream1/58

 aNo. participants reporting event/total no. participants.