eTable 3. Characteristics of the 16 included RCTs.
Author, year, country, |
Intervention |
No. of randomized patients |
Inclusion criteria and diagnosis |
Study
duration |
Severity
(lesions: n) |
Age
(years) |
Sex (female: n;%) |
Definition of cure/effect |
Findings after 2 weeks |
Findings after 4 weeks |
Comments |
Topical permethrin vs. topical crotamiton | |||||||||||
Amer (1992) Egypt (13) |
Permethrin 5% topical on 2 consecutive nights | 50 | Clinical diagnosis (microscopic evidence of mites) | 4 weeks | N/S | N/S | N/S | Complete cure of all lesions | N/A | 49/50 | Inpatients; unclear whether contact persons were also treated; whole-body treatment; 3rd trial arm (lindane) not evaluated |
Crotamiton 10% topical on 2 consecutive nights | 50 | 44/50 | |||||||||
Taplin (1990) Panama (12) |
Permethrin 5% cream, single application overnight (AC) | 48 | Children aged 2 months to 5 years; diagnosis of scabies, live mites on at least one part of body | 4 weeks + up to 3 weeks permethrin 5% cream if treatment failed | < 50: 29 50 to 100: 17 100: 2 |
2.6 ± 1.8 | 24 (50.0%) | Complete cure of all lesions | 14/47 | 42/47 | Whole-body treatment; only children from a remote island were included; 65/96 children with reinfestation at start of trial; one LTF per trial group; relatives treated with permethrin 5% cream; trial staff removed mites from skin using sterile tweezers in approx. 50% of patients |
Crotamiton 10% cream, single application overnight (AC) | 48 | < 50: 29 50 to 100: 15 > 100: 4 |
2.5 ± 1.8 | 30 (62.5%) | 6/47 | 28/47 10 children had undergone repeat treatment |
|||||
Topical permethrin vs. systemic ivermectin | |||||||||||
Bachewar (2009) India (17) |
Permethrin 5% cream overnight | 34 | Newly diagnosed scabies, age over 12 years, enrolled if at least 3 of the following 5 criteria were met: contact with scabies patient, nocturnal pruritus, positive family history, typical mite burrows on clinical examination, typical scabies lesions such as papules, nodules, or vesicles | 2 weeks | N/S | 12 to 41 (84%) |
12 (35.3%) | No new lesions | 27/28 | N/A | All patients received BB 25% lotion for their relatives and close contact persons; topical whole-body treatment |
Ivermectin 0.2 mg/kg oral, single dose | 34 | 16 (47.1%) | 27/27 | ||||||||
BB 25% lotion on 2 consecutive evenings | 35 | 12 (34.3%) | 23/25 | ||||||||
Chhaiya (2012) India (14) |
Permethrin 5% cream, single application for at least 8 hours (AP) | 105 | Either sex aged 5 to 80 years with 1. clinically-diagnosed scabies, 2. presence of typical scabietic lesions like papules, nodules, or vesicles at classical sites, 3. presence of classical burrows on clinical examination, 4. nocturnal pruritus, 5. history of involvement of family member or similar symptoms in contacts, 6. microscopically-diagnosed scabies (demonstration of egg, larvae, mite, or fecal matter), 7. patients whose microscopic examination was negative, their inclusion in the study was based on clinical criteria, for that patient had to meet at least 3 out of 4 inclusion criteria (inclusion criteria no. 2 to 5), no top. scabicidal therapy for 1 months | 3 weeks + treatment change to permethrin 5% at 4 weeks if treatment failed | Severe: 13.1% Moderate: 36.4% Mild: 46.5% None: 4% | 23.40 ± 13.55 |
47 (44.8%) | Clinical cure | 99% n? |
99/99 | Topical whole-body treatment; concomitant antihistamines: oral hydroxyzine 10 mg or 25 mg b.i.d. for all patients in week 1, subsequently in event of moderate to severe itching |
Ivermectin 0.2 mg/kg oral, single dose (AP) | 105 | Severe: 19% Moderate: 39% Mild: 38% None: 4% |
21.97 ± 13.26 |
47 (44.8%) | 63% n? |
99/100 | |||||
Ivermectin 1% lotion, single application to affected areas for at least 8 hours (AP) | 105 | Severe:16.8% Moderate: 40.6% Mild: 38.6% None: 4% |
22.52 ± 12.69 |
46 (43.8%) | 100% n? |
101/101 | |||||
Usha (2000) India (21) |
Permethrin 5% cream, single application overnight (AP) | 45 | Age >5 years; diagnosis of scabies (demonstration of eggs, larva, mites, or fecal pellets by light microscopy or by the presence of at least 3 of the following clinical criteria confirmed independently by 2 consultants: (1) demonstration of burrow, (2) presence of scabietic lesions at the classical sites, (3) nocturnal pruritus, and (4) family history of similar illness); no antiscabietic treatment in the previous month | 2 months | Severe: 8.9% Moderate: 51.1% Mild: 40.0% |
22.4 ± 12.6 |
12 (26.7%) | Clinical improvement in lesions, no new lesions | 44/45 Repeat treatments: 1 |
45/45 | Family contacts underwent same treatment as trial patients |
Ivermectin 0.2 mg/kg oral, single dose (AP, supervised) | 40 | Severe: 12.5% Moderate: 60.0% Mild: 27.5% |
21.28 ± 13.44 |
14 (35%) | 28/40 Repeat treatments: 12 |
38/40 | |||||
Saqib (2012) Pakista n (19) |
Permethrin 5% lotion for 10 to 12 hours (AP) | 60 | Confirmed diagnosis of scabies (evidence of mite burrows using dying and microscopic evidence of Sarcoptes scabiei mites at any stage of development or fecal matter), age 18 to 60 years, no topical or systemic scabicides in last month | 2 weeks | Itching: Severe: 10% Moderate: 70% Mild: 20% |
29.45 ± 9.72 |
N/S | Cure | 40/60 | N/A | Topical whole-body treatment (neck to foot); all patients. were given antihistamines at bed time during 1st week; contact persons of both groups underwent same treatment at same time as trial patients (children under 5 years old, pregnant women, or breastfeeding women received 5 to 10% sulfur ointment) |
Ivermectin 0.2 mg/kg oral, single dose (AP, supervised) | 60 | Itching: Severe: 16.7% Moderate: 53.3% Mild: 30% |
31.45 ± 12.78 |
40/60 | |||||||
Sharma (2011) India (20) |
Permethrin 5% cream, single application in evening (day 1) + placebo tablets (days 1 and 15) before breakfast (AP) | 40 | Age over 5 years and/or weight over 15 kg, diagnosis of scabies (eggs, larvae, mites/mite remains, or fecal matter under light microscope in scrapings of multiple representative or suspected skin changes in 10% KOH), and/or at least 3 of the following criteria: (a) mite burrows, (b) scabies lesions in typical locations, (c) nocturnal itching, (d) positive family history of similar complaints; no topical scabicides or topical steroids in last month | 4 weeks | Severe: 65% Moderate: 35% Mild: 0% |
21.38 ± 13.17 |
21 (52.5%) | ≥50% reduction in lesion count |
37/38 |
38/38 | Topical whole-body treatment (neck downwards); all family contacts received permethrin 5% cream for single use overnight |
Ivermectin 0.2 mg/kg oral, single dose before breakfast, placebo cream in evening (day 1), placebo tablet (day 15) (AP) | 40 | Severe: 72.5% Moderate: 27.5% Mild: 0% |
23.40 ± 11.03 |
11 (27.5%) | 38/40 | 36/40 | |||||
Ivermectin 0.2 mg/kg oral on days 1 and 15 before breakfast + placebo cream (day 1) in evening (AP) | 40 | Severe: 69.2% Moderate: 30.8% Mild: 0% |
23.53 ± 12.73 |
16 (40.0%) | 36/39 | 36/39 | |||||
Mushtaq (2010) Pakista n (18) |
Permethrin 5% cream single application overnight for 12 hours | 42 patients completed the trial | Age 2 to 60 years; diagnosis of scabies | 6 months | N/S | N/S | 20 (45.5%) | Cure (no lesions) | 20/42 | 37/42 | Topical whole-body treatment; information on sex shown in table unclear; 14 LTF corresponds to no. of patients not cured after 4 weeks |
Ivermectin 0.2 mg/kg oral, single dose | 44 patients completed the trial | 24 (54.5%) | 24/44 | 35/44 | |||||||
Romani (2015) Fiji (26) |
Permethrin for all affected individuals and their contact persons, single application | 803 | 3 previously identified island communities were randomized to 3 treatment options; trial participation was open to all inhabitants; inhabitants were treated according to their treatment group | 12 months | Severe: 5.8% Moderate: 24.8% Mild: 69.4% |
Median (IQR): 22 (8 to 44) |
398 (49.6%) | No. of patients with diagnosis of scabies after 12 months | 140/746 | Topical whole-body treatment (neck to foot); in the ivermectin group children weighing less than 15 kg, pregnant/breastfeeding women, persons with neurological diseases, and persons taking cytochrome P450 inducers or inhibitors received permethrin cream instead of ivermectin | |
Permethrin for all individuals, single dose (2nd dose in those with scabies at start of trial on days 7 to 14) for 8 to 24 hours (AP with or without supervision) | 532 | Severe: 17.1% Moderate: 32% Mild: 50.9% |
Median (IQR): 25 (8 to 47) |
258 (48.5%) | 71/449 | ||||||
Ivermectin 0.2 mg/kg oral for all individuals, single dose (2nd dose for those with scabies at start of trial on days 7 to 14), supervised | 716 (93 received permethrin) | Severe: 10.9% Moderate: 29.1% Mild: 60% |
Median (IQR): 24 (8 to 44) |
331 (46.2%) | 11/587 | ||||||
Systemic ivermectin vs. systemic ivermectin | |||||||||||
See above: Sharma (2011) (20) | |||||||||||
Topical ivermectin vs. systemic ivermectin | |||||||||||
See above: Chhaiya (2012) (14) | |||||||||||
Topical permethrin vs. topical ivermectin | |||||||||||
See above: Chhaiya (2012) (14). Sharma (2011) (20) | |||||||||||
BB vs. systemic ivermectin | |||||||||||
Ly (2009) Senegal (25) |
BB 12.5%, single application for 24 hours (AP) |
68 | Age 5 to 65 years, weight 15 kg or more, itching in 3 or more significant parts of the body, typical scabies lesions (i.e. vesicles, papules, nodules, or pustules) in 3 or more locations typical for scabies (i.e. interdigital folds of hands, elbows, joints of hands, buttocks, underarms, nipples and areolas in women, external genitalia in men); no scabies treatment during the month before consultation | 4 weeks + 2 weeks (if treatment failed in the ivermectin or BB group with single application, patients received second application; if treatment failed after second application in the BB group, patients received ivermectin) | No. of affected locations (n patients): ≤5 n = 41 ≥6 n = 27 |
16.5 (5 to 63) | 25 (36.8%) | Complete cure of visible lesions | 37/68 | 52/68 | Information on treatment of relatives unclear: same treatment as trial patients/relatives not enrolled in the trial received single-dose BB |
BB 12.5%, 2 applications at 24-hour intervals (AP) | 48 | No. of affected locations (n patients): ≤5 n = 30 ≥6 n = 18 |
20 (41.7%) | 33/48 | 46/48 | ||||||
Ivermectin 0.15 to 0.2 mg/kg oral, single dose (AP) |
65 | No. of affected locations (n patients): ≤5 n = 31 ≥6 n = 34 |
20 (30.8%) | 16/65: 8 patients underwent repeat treatment after 1 week | 28/65 | ||||||
Brooks (2002) Vanuatu (24) |
BB 10%, single application (APP) | 37 (at follow-up) | Children aged 0.5 to 14/15 years; diagnosis of scabies (typical lesions: mite burrow, intact papulovesicular lesions or excoriated, encrusted lesions); no scabies treatment in last 2 months | 3 weeks | No. of lesions: 44.9 ± 31.9 |
Week 3: 4.7 ± 3.8 |
N/S | No lesions after 3 weeks | 19/37 | N/A | Relatives underwent same treatment as trial patients; children under 6 months received BB; 30 LTF |
Ivermectin 0.2 mg/kg oral, single dose (AC) |
43 (at follow-up) | No. of lesions: 50.7 ± 29.1 |
Week 3: 5.1 ± 3.9 |
24/43 | |||||||
Glaziou (1993) French Polynesia (23) |
Ivermectin 100 µg/kg, single dose |
23 | Scabies, clinically diagnosed, defined as itching and at least one typical mite burrow; age 5 to 60 years, no scabies treatment in last 2 weeks | 4 weeks | Clinical score [0 to 24] Mean (range): 13.0 (4 to 22) |
17.5 (5 to 56) | 21 (47.7%) | Complete cure of initial lesion | 8/23 | 16/23 | Topical whole-body treatment (excluding head); all household members treated with BB 10% at same time as trial patients; one concomitant antibiotic treatment was allowed if necessary |
BB 10% to 12 hours, then washed off, application repeated (AP) |
21 | Clinical score [0 to 24] Mean (range): 13.1 (6 to 22) |
3/21 | 10/21 | |||||||
Nnoruka (2001) Nigeria (22) |
Ivermectin 200 µg/kg, single dose |
29 | Age over 5 years; scabies confirmed clinically and using laboratory tests (itching with at least one typical mite burrow or several pustular eruptions, blisters, or nodules); pre-existing lesions for approx. 2 weeks to 3 months or more on initial presentation | 4 weeks | Clinical score [0 to 24] Mean (range): 16.1 (4 to 28.2) |
27.9 (5 to 63) | Inconsistent data in text: 33 women + 35 men = 68 patients; 33 (48.5%) | Complete cure of initial lesions | 19/29 | 27/29 | Topical whole-body treatment (neck to foot); all household members underwent same treatment at same time as trial patients |
BB 25% emulsion for 72 hours |
29 | Clinical score [0 to 24] Mean (range): 16.0 (6 to 26) |
10/29 | 14/29 | |||||||
See above: Bachewar (2009) | |||||||||||
BB vs. sulfur | |||||||||||
Gulati (1978) India (15) |
Sulfur ointment in morning, at night, and on following morning (AP) | 69 | Scabies diagnosed on basis of clinical findings | 6 months | N/S | 16.9 ± 16.1 |
35 (50.7%) | Clearance of lesions | 67/69 | N/A | Families also treated; whole-body treatment |
BB 25% emulsion in morning, at night, and on following morning (AP) | 89 | 16.4 ± 17.0 |
48 (53.9%) | 81/89 | |||||||
Sulfur vs. sulfur or other | |||||||||||
Avila-Romay (1991) Mexico (27) |
Sulfur 10% cold cream on 3 consecutive nights and one night 3 days later (AP, supervised) | 26 (+32 contact persons) | Resident of orphanage, age 6 to 17 years | N/S | N/S | 6 to 17 years |
N/S | No cutaneous lesions after 10 days | 26/26 | N/A | Orphanage; all contact persons also randomized and treated; whole-body treatment |
Sulfur 10% and salicylic acid 1% in pork fat on 3 nights and one night 3 days later (AP, supervised) | 25 (+28 contact persons) | 22/25 | |||||||||
Sharquie (2012) Iraq (16) |
Sulfur 8% and 10%, single application | 33 | Clinical history and clinical examination, confirmed mainly via mite extraction and viewing under light microscope of mites, ova, or scybala; age over 2 years; new infestations excluded | 4 weeks | 100% of patients had mite burrows. | Male: 26.74 ± 15.98 Female: 24.05 ± 14.53 (similar in both groups) |
15 (45.5%) | Cure of mite burrows | 18/33 | 14/33 | – |
Sulfur 8% and 10% on 3 consecutive nights | 32 | 11 (34.4%) | 30/32 | 29/32 | |||||||
Sulfur 8% and 10% on 3 consecutive days | 32 | 13 (40.6%) | 31/32 | 31/32 |
BB: Benzyl benzoate; b.i.d.: Twice a day; APP: Applied by patients’ parents; AC: Applied by specialized clinical staff; LTF: Lost to follow-up; N/S: Not stated; N/A: Not applicable; AP: Applied by patients; q.d.: Once a day