Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Oral ivermectin versus 5% permethrin cream to treat children and adults with classic scabies: multicentre, assessor blinded, cluster randomised clinical trial.

Name: Kaimen Rigor review — Oral ivermectin versus 5% permethrin cream to treat children and adults with classic scabies: multicentre, assessor blinded, cluster randomised clinical trial.
Item: Oral ivermectin versus 5% permethrin cream to treat children and adults with classic scabies: multicentre, assessor blinded, cluster randomised clinical trial.
Rating: 94
Author: Alpha1

Boralevi F, Simon G, Bernigaud C, Brun J, Goujon E, Perrot JL, Phan A, Hérissé AL, Maruani A, Vanhaecke C, Couty E, Abasq-Thomas C, Fournet M, Mallet S, Brenaut E, Hubiche T, Balguerie X, Caux F, Beneton N, Dutkiewicz AS, Adamski H, Aubert H, Bourrat E, Couzan C, Eyraud A, Janela-Lapert R, Marti A, Miquel J, Richard M, Barbarot S, Bonniaud B, Chabbert C, Delion F, Dinulescu M, Duong TA, Etienne M, Hirsch G, Isnard C, Huet F, Le Bidre E, Leducq S, Legrand A, Monestier S, Morice-Picard F, Seneschal J, Capelli A, Lacoste C, Labrèze C, Miraglia G, Do-Pham G, Giraudeau B, Chosidow O

Paper source

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Kaimen Rigor review — 3.25★ (Adequate), 0 critical, 3 high issues for “Oral ivermectin versus 5% permethrin cream to treat children and adults with classic scabies: multicentre, assessor blinded, cluster randomised clinical trial.”

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Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 10, 2026

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Oral ivermectin versus 5% permethrin cream to treat children and adults with classic scabies: multicentre, assessor blinded, cluster randomised clinical trial.

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DOI

10.1136/bmj-2025-086277

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01ce79e51b176e2ab8192dbd82e3e12b022fc6086c21f276c640d4f1fe2614ff

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Issued Aug 10, 2026Engine 7.29.0

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Oral ivermectin versus 5% permethrin cream to treat children and adults with classic scabies: multicentre, assessor blinded, cluster randomised clinical trial.

Paper source

Oral ivermectin versus 5% permethrin cream to treat children and adults with classic scabies: multicentre, assessor blinded, cluster randomised clinical trial.

Read full text (PMC)

Embed this Rigor badge

Links back to this Kaimen Rigor review.

Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 10, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

3.25 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
ClaimsUnsupported claim (uncorroborated)−0.5★
ReportingEthical approvals partially met−0.25★

Model-reported confidence: moderateReviewer agreement: highEngine: 7.29.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run on this paper: the pass that reads its reported means did not complete. No reported mean was checked for arithmetic impossibility.

Biggest issues

01Conclusion not supported by the paper’s own evidence
highOverreachreviewer-assessedFull detail
In other situations, first line oral ivermectin could be prescribed, especially when topical application is not practical.
“In other situations, first line oral ivermectin could be prescribed, especially when topical application is not practical, for example in older adults, especially residents with dementia during a scabies outbreak in a nursing home, or in people experiencing…”
DiscussionFind in source

Findings by category

101ArithmeticNumerical inconsistencies 202OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found 06Copyedit4 minor suggestions

This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

This cluster-randomised, assessor-blinded, active-comparator trial is rigorously designed and, with two small caveats, transparently reported: the premise is well-evidenced, the negative primary result and limitations are disclosed, and data and code are openly deposited (verified live). The weaknesses are reporting gaps rather than scientific defects: a missing explicit Helsinki/ICH-GCP statement, a sample-size calculation that (as disclosed) ignored clustering, one unsupported Discussion extrapolation about first-line ivermectin in untested settings, and minor Table 2 denominator inconsistencies plus two copyedit slips.

Both evaluations are independent samples of the same model applied to the full text; they agreed on 7/8 dimension statuses and diverged only on ethical approvals (R1 pass vs R2 warn), resolved to warn on the strength of the specific absence finding. Machine checks: 42 references checked (0 retracted, 0 not found), one recomputable statistic consistent, two repository URLs live, prospective registration and CONSORT confirmed — most inferential results were not machine-verifiable and remain unverified.

Numerical inconsistencies

1 finding · worst low

Values that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.

Internal contradictions in the reported numbersAssessed

Recomputed 1 test: 1 consistent, 0 inconsistent; 1 via agent-written checks.

Overstated conclusions

2 findings · worst high

Conclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.

Conclusions not supported by the paper’s own evidenceAssessed
Conclusions only partially backed by the presented evidenceAssessed

9 major claims checked against the paper's own evidence: 1 not fully backed by the presented evidence (unsupported or overstated).

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Data authenticity concerns

None found

An adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.

Checked — nothing surfaced.

Reporting gaps

1 finding · worst medium

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Ethics/consent reporting incompleteAssessed

Eight Dimensions7 pass · 1 warn

Prior work is cited extensively (WHO burden data, two Cochrane systematic reviews with contradictory conclusions, a 2017 network meta-analysis). The rationale is explicit: uncertainty about non-inferiority/superiority motivated the trial. Limitations of prior RCTs are concretely addressed — dermoscopic confirmation, cluster design for household transmission, day-28 evaluation for non-ovicidal drugs, and masking of assessors.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The introduction establishes a clear evidence gap (contradictory Cochrane reviews, no major RCTs 2007–2018) and derives the trial design directly from five enumerated methodological flaws in prior work.

Evidence

“the conclusions of two Cochrane systematic reviews, published in 2007 and 2018, were contradictory: permethrin superiority or no difference in efficacy between the drugs, possibly explained by endpoint differences.”

Introduction ¶3Find in source

“The non-inferiority or superiority of both scabicide drugs is uncertain, and therefore we conducted a cluster designed, assessor blinded, randomised controlled trial comparing oral ivermectin with 5% permethrin cream”

IntroductionFind in source

“five methodological flaws potentially account for the research gap (ie, the lack of study consensus on the superiority or non-inferiority of a drug).”

Introduction ¶4Find in source

PASSReviewer 2· 95% conf

The paper clearly establishes the scientific foundation by citing prior contradictory Cochrane reviews, identifying methodological flaws, and explaining how the current trial addresses them.

Evidence

paraphrase[Introduction, paragraph 1-4]

“The Introduction cites two Cochrane systematic reviews (2007, 2018) with contradictory conclusions, discusses methodological flaws in prior trials, and outlines how these are addressed.”

IntroductionFind in source

Randomisation was by an independent statistician using a 1:1 list with blocks of four, grouped by centre; the unit was the household cluster. Blinding is explicitly limited to assessors with a stated rationale for not doing a double-blind double-dummy design. A power calculation (80% cure each arm, 10% margin, 2.5% one-sided alpha, 80% power, 502 clusters) is reported. Inclusion/exclusion criteria are pre-specified. Missing data were handled by multiple imputation (fully conditional specification), satisfying the missing-data/analysis-population expectation.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

A well-specified cluster-randomised design with stated randomisation method and unit, assessor masking with a feasibility rationale, a priori power calculation, pre-specified inclusion/exclusion criteria, and a defined missing-data approach.

Evidence

“An independent statistician, not involved in the recruitment of index cases or clusters, generated a 1:1 randomisation list with blocks of four, grouped according to centre.”

MethodsFind in source

paraphrase[Methods; Discussion]

“Only endpoint assessors were masked. ... The ideal double blind, double dummy design was not undertaken because of poor feasibility.”

“Assuming a 2.5% one sided type I error rate and 80% power, recruitment of 502 clusters was required.”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The study design is rigorous with appropriate randomisation, blinding, and handling of missing data, though the sample size calculation did not account for clustering, which is a minor flaw.

Evidence

“An independent statistician, not involved in the recruitment of index cases or clusters, generated a 1:1 randomisation list with blocks of four, grouped according to centre.”

MethodsFind in source

“sample size calculation was standard (ie, without considering any clustering) on the basis of the hypothesis that the cluster level cure rate would be 80% in each arm, with a 10% non-inferiority margin.”

Statistical analysisFind in source

“Missing values were managed with a multiple imputation approach based on the fully conditional specification method.”

Statistical analysisFind in source

Table 1 (index cases) and Table 2 (cluster members) report sex, median age with IQR, weight, height, and medical history (e.g., atopic dermatitis, prior scabies treatment, corticosteroid/immunosuppressive use). Race/ethnicity is not reported, but the core demographic and health variables are comprehensive. Species/strain/housing criteria are not applicable for a human trial.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Sex, age, weight, height, and relevant comorbidities are reported for index cases and cluster members in baseline tables; both sexes were enrolled so no single-sex justification is needed.

Evidence

paraphrase[Table 1]

“Male | 76 (53.5) | 73 (49.7) ... Female | 66 (46.5) | 74 (50.3)”

“Median (IQR) age (years) | 15.9 (7.9-29.9) | 15.8 (8.0-27.5)”

Table 1Find in source

paraphrase[Table 1]

“Atopic dermatitis:* | Yes | 20 (14.1) | 17 (11.6)”

PASSReviewer 2· 85% conf

Sex, age, weight, and health status are reported for index cases and cluster members, but race/ethnicity is not reported, which is a minor omission.

Evidence

paraphrase[Table 1]

“Median (IQR) age (years) | 15.9 (7.9-29.9) | 15.8 (8.0-27.5) | Sex: Male | 76 (53.5) | 73 (49.7) | Female | 66 (46.5) | 74 (50.3) |”

absence[Table 1, Table 2]

Race/ethnicity is not reported.

The trial was approved by the French National Ethics Committee (CPP SOOM 3) and the National Agency for the Safety of Medicines and Health Products (ANSM). Written informed consent was obtained from all participants or their legal representatives. However, the paper does not include a statement such as 'the study was conducted in accordance with the Declaration of Helsinki' or 'ICH-GCP', which is required for adequate regulatory compliance reporting.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceNOT REPORTED

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

A named national ethics committee approved the protocol, written informed consent is documented for all participant types, and approval by the national medicines agency plus EudraCT registration constitute regulatory compliance.

Evidence

“approved by the local principal investigators, the French National Ethics Committee (CPP SOOM 3), and the National Agency for the Safety of Medicines and Health Products (ANSM).”

Methods ¶1Find in source

“All participants (ie, adults, children’s parents or legally authorised representatives, and children) provided written informed consent.”

Methods ¶1Find in source

paraphrase[Ethics statements]

“The trial was registered prospectively with ClinicalTrials.gov ( NCT02407782 ) and EudraCT (2014-002493-36).”

WARNReviewer 2· 90% conf

Ethics approval and informed consent are reported, but the paper does not explicitly state adherence to a recognized regulatory framework (e.g., Declaration of Helsinki), which is a minor reporting gap.

Evidence

paraphrase[Methods, first paragraph]

“The trial protocol was approved by the French National Ethics Committee (CPP SOOM 3), and the National Agency for the Safety of Medicines and Health Products (ANSM).”

“All participants (ie, adults, children’s parents or legally authorised representatives, and children) provided written informed consent.”

Methods ¶1Find in source

absence[Methods, Ethics statements]

No explicit statement of adherence to a regulatory framework.

Both drugs are identified with dose (ivermectin 200 µg/kg; 5% permethrin cream), regimen (day 0 and day 10), and application instructions; the suppliers (MSD-Merck and Codexial) are named in the competing-interests section. SAS version 9.4 is identified for analysis. Antibodies, cell lines, mycoplasma, and organisms are not applicable to this drug trial.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational products (oral ivermectin, 5% permethrin cream) are named with formulation, dose, regimen, and manufacturer/source, and the analysis software is identified; bench-resource criteria are not applicable.

Evidence

“All participants received oral ivermectin 200 µg/kg or 5% permethrin cream on day 0 and day 10.”

AbstractFind in source

“oral ivermectin and topical 5% permethrin were provided free of charge by MSD-Merck and Codexial, respectively”

Competing interestsFind in source

“For statistical analyses, we used SAS version 9.4 software.”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

The investigational products (ivermectin and permethrin) are named with source, dose, and regimen; statistical software and code are identified.

Evidence

“for part of the study, oral ivermectin and topical 5% permethrin were provided free of charge by MSD-Merck and Codexial, respectively”

Competing interestsFind in source

“For statistical analyses, we used SAS version 9.4 software. Codes are available at https://doi.org/10.5061/dryad.sn02v6xjd”

Statistical analysisFind in source

Mixed models with centre as random and multiple imputation are described; effect sizes are reported as risk differences with 95% CIs across cluster, index-case, and participant analyses, so exact_p_values is not applicable (estimation idiom). I verified the printed proportions against the printed counts (e.g., 94/132=71.2%, 114/127=89.8%, 407/479=85.0%, 434/446=97.3%) and baseline percentages; all were consistent. A few Table 2 sub-row denominators are short by 1–2 participants (relationship row sums to 420 vs n=421; atopic dermatitis 363 vs 365), consistent with unstated missing values, not arithmetic errors.

Sub-criteria

tests namedADEQUATE

exact p valuesN/A

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial reports by estimation (effect estimates with 95% CIs, no p-values), the field norm for such trials; models are named, software is specified, and the reported arithmetic in cure-rate and baseline tables checks out.

Evidence

“For cluster level and index case outcomes, mixed models were fitted with the centre considered random.”

Statistical analysisFind in source

“–16.7 percentage point difference, 95% CI –26.3 to –7.1”

Table 3Find in source

“Completer participants† | 94/132 (71.2) | 114/127 (89.8)”

Table 3Find in source

PASSReviewer 2· 80% conf

Statistical tests are named, effect sizes are reported with confidence intervals, and software is identified. The analysis is appropriate for a cluster trial, though assumptions are not explicitly verified.

Evidence

“For cluster level and index case outcomes, mixed models were fitted with the centre considered random. The identity link function was used, which allowed estimations of risk difference.”

Statistical analysisFind in source

“71.8% versus 88.5% (–16.7 percentage point difference, 95% confidence interval (CI) –26.3 to –7.1)”

Table 3Find in source

“For statistical analyses, we used SAS version 9.4 software.”

Statistical analysisFind in source

A data-availability statement gives a concrete route (Dryad DOI). The underlying data and the analysis code are both deposited at the same Dryad DOI, satisfying repository deposit and code sharing. Sequencing accession numbers are not applicable to this clinical trial.

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Data and analysis code are openly deposited in Dryad with a persistent DOI, and the data-availability statement names a concrete access route.

Evidence

“The data underlying the findings in this paper are openly and publicly available and can be found here: ( https://doi.org/10.5061/dryad.sn02v6xjd ).”

Data availabilityFind in source

“Codes are available at https://doi.org/10.5061/dryad.sn02v6xjd .”

Statistical analysisFind in source

PASSReviewer 2· 95% conf

Data and code are openly available in a public repository (Dryad) with a DOI.

Evidence

“The data underlying the findings in this paper are openly and publicly available and can be found here: ( https://doi.org/10.5061/dryad.sn02v6xjd ).”

Data availabilityFind in source

“Codes are available at https://doi.org/10.5061/dryad.sn02v6xjd”

Statistical analysisFind in source

Methods are detailed enough to replicate (treatments, dosing, timing, outcome definitions). Trial registration (NCT02407782, EudraCT) is stated as prospective. CONSORT (with cluster and non-inferiority extensions) is referenced. The negative primary outcome (non-inferiority not shown) and the underpowered day-56 assessment are transparently reported. Limitations are discussed explicitly. Conclusions are proportional to the data. Funding source and ICMJE competing-interest declarations are provided.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The manuscript follows CONSORT with its cluster and non-inferiority extensions, is prospectively registered, reports all outcomes including the negative primary result, discusses limitations at length, and declares funding and competing interests.

Evidence

“our report followed the Consolidated Standards of Reporting Trials (CONSORT) guideline for parallel group randomised trials and its extension to non-inferiority and cluster trials.”

Methods ¶1Find in source

“Trial registration NCT02407782 (https://clinicaltrials.gov/ct2/show/NCT02407782) .”

AbstractFind in source

“The study was funded by the French Ministry of Health (Programme Hospitalier de Recherche Clinique, PHRC-N 2011) and the French Society of Dermatology.”

FundingFind in source

PASSReviewer 2· 95% conf

The manuscript is transparent: methods are detailed, trial is registered, CONSORT guidelines are followed, outcomes are reported, limitations are discussed, and funding/COI are disclosed.

Evidence

“Trial registration NCT02407782 (https://clinicaltrials.gov/ct2/show/NCT02407782)”

AbstractFind in source

“Our report followed the Consolidated Standards of Reporting Trials (CONSORT) guideline for parallel group randomised trials and its extension to non-inferiority and cluster trials.”

Methods ¶1Find in source

“Our study had some limitations. The generalisability of our results is restricted to patients without diffuse eczematisation or extensive impetiginisation.”

LimitationsFind in source

Registered (2 IDs: ClinicalTrials.gov, EudraCT). Reporting guideline cited: CONSORT.

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 42 references by DOI: 37 verified — 5 no DOI (shown, not verified).

2 data/code links checked; 2 live.

Copyediting

4 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 4 minor suggestions below.

4 copyedit issues flagged: mostly other, typo, grammar.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published paper is robust, and no retraction-level concern arises; an informed reader should weigh the cluster-unadjusted power calculation when interpreting the failed non-inferiority, the unsupported Discussion extrapolation about first-line ivermectin in settings not studied, and the missing Helsinki/ICH-GCP statement, alongside the minor Table 2 footnotes and typos. A correction/erratum addressing the claim over-reach, the ethics-framework statement, and the Table 2 missing-data footnotes — plus a cluster-informed power re-analysis — would materially strengthen confidence.

1.
HIGHrigor
Add supporting evidence for, or temper/remove, the Discussion claim that 'in other situations, first line oral ivermectin could be prescribed, especially when topical application is not practical' — the trial provides no efficacy data for nursing homes, prisons, or other settings where topical application is impractical, so the sentence should be flagged as an extrapolation or supported with cited external evidence.
An unsupported extrapolation beyond the studied population is the one substantive over-reach in an otherwise proportionally worded report, and the claim audit flagged it as under-evidenced.
2.
HIGHethics
Add an explicit statement in the Ethics section (e.g., in a correction/erratum) that the trial was conducted in accordance with the Declaration of Helsinki and ICH-GCP guidelines.
The Ethics section names the approving committees and registration but lacks the explicit framework-adherence statement, which is the basis of the ethical_approvals 'warn'.
3.
HIGHstatistics
Add a cluster-adjusted power re-analysis (design effect / intraclass correlation coefficient and effective power) as a supplementary analysis or correction, since the reported sample size calculation was 'standard (ie, without considering any clustering)' in a cluster-randomised trial.
Without an ICC-adjusted power estimate, readers cannot judge how much the ignored clustering reduced power for the failed non-inferiority primary outcome.
4.
MEDIUMcopyedit
Remove the duplicated word in the Results adverse-events sentence ('...potentially related to the study drug related...') and change 'of adverse events' to 'of participants' (14/142 and 20/147 are participant percentages).
The duplicated word is an obvious typo, and the mislabelled denominator could mislead a careful reader.
5.
MEDIUMcopyedit
Change the Table 3 column header 'Cures rate difference (percentage points (95% CI))' to 'Cure rate difference (percentage points (95% CI))' for consistency with the singular usage elsewhere in the table and text.
Inconsistent terminology in a key results table is easily caught by reviewers and detracts from an otherwise clean presentation.
6.
MEDIUMreporting
Add footnotes to Table 2 disclosing the two unstated missing values: the relationship-to-index-case categories sum to 420 vs the stated n=421, and the atopic-dermatitis rows sum to 363 vs n=365, with percentages computed from the smaller denominators.
These low-severity internal contradictions (flagged by the integrity check) are harmless if footnoted as missing data but look like arithmetic errors if left unexplained.
7.
MEDIUMreporting
Either add race/ethnicity to the baseline tables (if collected) or add a sentence in Methods or Limitations explaining why it is not reported (e.g., not routinely collected in France).
The demographics sub-criterion was marked reported_but_inadequate solely because race/ethnicity is absent; a justification closes the gap without new data.
8.
LOWstatistics
Add a sentence or supplement citing support for the robustness of the pre-specified mixed models (e.g., residual diagnostics or bootstrap sensitivity) so that model assumptions are verifiable.
R2 noted that mixed-model assumptions are not discussed; this is adequate for a pre-specified analysis model, but explicit diagnostics would strengthen verifiability.
9.
LOWreporting
Move or duplicate the manufacturer/source statement (ivermectin from MSD-Merck, permethrin from Codexial) from Competing interests into the Methods 'Intervention' section.
Readers should not need to consult the competing-interest statement to identify the source of the investigational products.
10.
LOWdata code
Clarify in the Data availability statement that the single Dryad DOI (10.5061/dryad.sn02v6xjd) contains both the dataset and the analysis code, or provide a separate code link.
Both URLs resolve and are content-consistent, so this is purely a clarity improvement for the shared data/code deposit.

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Oral ivermectin versus 5% permethrin cream to treat children and adults with classic scabies: multicentre, assessor blinded, cluster randomised clinical trial.

Read full text (PMC)

DOI

10.1136/bmj-2025-086277

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Record fingerprint

01ce79e51b176e2ab8192dbd82e3e12b022fc6086c21f276c640d4f1fe2614ff

Verify via API

Issued Aug 10, 2026Engine 7.29.0

Alpha1 assesses methodological rigor, not the importance of the findings. See how we calibrate →

Kaimen Rigor review

Kaimen Rigor reviewed

3.25 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
ClaimsUnsupported claim (uncorroborated)−0.5★
ReportingEthical approvals partially met−0.25★

Model-reported confidence: moderateReviewer agreement: highEngine: 7.29.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run on this paper: the pass that reads its reported means did not complete. No reported mean was checked for arithmetic impossibility.

Biggest issues

01Conclusion not supported by the paper’s own evidence
highOverreachreviewer-assessedFull detail
In other situations, first line oral ivermectin could be prescribed, especially when topical application is not practical.
“In other situations, first line oral ivermectin could be prescribed, especially when topical application is not practical, for example in older adults, especially residents with dementia during a scabies outbreak in a nursing home, or in people experiencing…”
DiscussionFind in source

Findings by category

101ArithmeticNumerical inconsistencies 202OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found 06Copyedit4 minor suggestions

Numerical inconsistencies

1 finding · worst low

Internal contradictions in the reported numbersAssessed

Recomputed 1 test: 1 consistent, 0 inconsistent; 1 via agent-written checks.

Overstated conclusions

2 findings · worst high

Conclusions not supported by the paper’s own evidenceAssessed
Conclusions only partially backed by the presented evidenceAssessed

9 major claims checked against the paper's own evidence: 1 not fully backed by the presented evidence (unsupported or overstated).

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

1 finding · worst medium

Ethics/consent reporting incompleteAssessed

Eight Dimensions7 pass · 1 warn

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Evidence

Introduction ¶3Find in source

IntroductionFind in source

“five methodological flaws potentially account for the research gap (ie, the lack of study consensus on the superiority or non-inferiority of a drug).”

Introduction ¶4Find in source

PASSReviewer 2· 95% conf

The paper clearly establishes the scientific foundation by citing prior contradictory Cochrane reviews, identifying methodological flaws, and explaining how the current trial addresses them.

Evidence

paraphrase[Introduction, paragraph 1-4]

“The Introduction cites two Cochrane systematic reviews (2007, 2018) with contradictory conclusions, discusses methodological flaws in prior trials, and outlines how these are addressed.”

IntroductionFind in source

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Evidence

“An independent statistician, not involved in the recruitment of index cases or clusters, generated a 1:1 randomisation list with blocks of four, grouped according to centre.”

MethodsFind in source

paraphrase[Methods; Discussion]

“Only endpoint assessors were masked. ... The ideal double blind, double dummy design was not undertaken because of poor feasibility.”

“Assuming a 2.5% one sided type I error rate and 80% power, recruitment of 502 clusters was required.”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The study design is rigorous with appropriate randomisation, blinding, and handling of missing data, though the sample size calculation did not account for clustering, which is a minor flaw.

Evidence

“An independent statistician, not involved in the recruitment of index cases or clusters, generated a 1:1 randomisation list with blocks of four, grouped according to centre.”

MethodsFind in source

Statistical analysisFind in source

“Missing values were managed with a multiple imputation approach based on the fully conditional specification method.”

Statistical analysisFind in source

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Sex, age, weight, height, and relevant comorbidities are reported for index cases and cluster members in baseline tables; both sexes were enrolled so no single-sex justification is needed.

Evidence

paraphrase[Table 1]

“Male | 76 (53.5) | 73 (49.7) ... Female | 66 (46.5) | 74 (50.3)”

“Median (IQR) age (years) | 15.9 (7.9-29.9) | 15.8 (8.0-27.5)”

Table 1Find in source

paraphrase[Table 1]

“Atopic dermatitis:* | Yes | 20 (14.1) | 17 (11.6)”

PASSReviewer 2· 85% conf

Sex, age, weight, and health status are reported for index cases and cluster members, but race/ethnicity is not reported, which is a minor omission.

Evidence

paraphrase[Table 1]

“Median (IQR) age (years) | 15.9 (7.9-29.9) | 15.8 (8.0-27.5) | Sex: Male | 76 (53.5) | 73 (49.7) | Female | 66 (46.5) | 74 (50.3) |”

absence[Table 1, Table 2]

Race/ethnicity is not reported.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceNOT REPORTED

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Evidence

“approved by the local principal investigators, the French National Ethics Committee (CPP SOOM 3), and the National Agency for the Safety of Medicines and Health Products (ANSM).”

Methods ¶1Find in source

“All participants (ie, adults, children’s parents or legally authorised representatives, and children) provided written informed consent.”

Methods ¶1Find in source

paraphrase[Ethics statements]

“The trial was registered prospectively with ClinicalTrials.gov ( NCT02407782 ) and EudraCT (2014-002493-36).”

WARNReviewer 2· 90% conf

Evidence

paraphrase[Methods, first paragraph]

“The trial protocol was approved by the French National Ethics Committee (CPP SOOM 3), and the National Agency for the Safety of Medicines and Health Products (ANSM).”

“All participants (ie, adults, children’s parents or legally authorised representatives, and children) provided written informed consent.”

Methods ¶1Find in source

absence[Methods, Ethics statements]

No explicit statement of adherence to a regulatory framework.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Evidence

“All participants received oral ivermectin 200 µg/kg or 5% permethrin cream on day 0 and day 10.”

AbstractFind in source

“oral ivermectin and topical 5% permethrin were provided free of charge by MSD-Merck and Codexial, respectively”

Competing interestsFind in source

“For statistical analyses, we used SAS version 9.4 software.”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

The investigational products (ivermectin and permethrin) are named with source, dose, and regimen; statistical software and code are identified.

Evidence

“for part of the study, oral ivermectin and topical 5% permethrin were provided free of charge by MSD-Merck and Codexial, respectively”

Competing interestsFind in source

“For statistical analyses, we used SAS version 9.4 software. Codes are available at https://doi.org/10.5061/dryad.sn02v6xjd”

Statistical analysisFind in source

Sub-criteria

tests namedADEQUATE

exact p valuesN/A

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Evidence

“For cluster level and index case outcomes, mixed models were fitted with the centre considered random.”

Statistical analysisFind in source

“–16.7 percentage point difference, 95% CI –26.3 to –7.1”

Table 3Find in source

“Completer participants† | 94/132 (71.2) | 114/127 (89.8)”

Table 3Find in source

PASSReviewer 2· 80% conf

Evidence

“For cluster level and index case outcomes, mixed models were fitted with the centre considered random. The identity link function was used, which allowed estimations of risk difference.”

Statistical analysisFind in source

“71.8% versus 88.5% (–16.7 percentage point difference, 95% confidence interval (CI) –26.3 to –7.1)”

Table 3Find in source

“For statistical analyses, we used SAS version 9.4 software.”

Statistical analysisFind in source

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Data and analysis code are openly deposited in Dryad with a persistent DOI, and the data-availability statement names a concrete access route.

Evidence

“The data underlying the findings in this paper are openly and publicly available and can be found here: ( https://doi.org/10.5061/dryad.sn02v6xjd ).”

Data availabilityFind in source

“Codes are available at https://doi.org/10.5061/dryad.sn02v6xjd .”

Statistical analysisFind in source

PASSReviewer 2· 95% conf

Data and code are openly available in a public repository (Dryad) with a DOI.

Evidence

“The data underlying the findings in this paper are openly and publicly available and can be found here: ( https://doi.org/10.5061/dryad.sn02v6xjd ).”

Data availabilityFind in source

“Codes are available at https://doi.org/10.5061/dryad.sn02v6xjd”

Statistical analysisFind in source

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Evidence

“our report followed the Consolidated Standards of Reporting Trials (CONSORT) guideline for parallel group randomised trials and its extension to non-inferiority and cluster trials.”

Methods ¶1Find in source

“Trial registration NCT02407782 (https://clinicaltrials.gov/ct2/show/NCT02407782) .”

AbstractFind in source

“The study was funded by the French Ministry of Health (Programme Hospitalier de Recherche Clinique, PHRC-N 2011) and the French Society of Dermatology.”

FundingFind in source

PASSReviewer 2· 95% conf

The manuscript is transparent: methods are detailed, trial is registered, CONSORT guidelines are followed, outcomes are reported, limitations are discussed, and funding/COI are disclosed.

Evidence

“Trial registration NCT02407782 (https://clinicaltrials.gov/ct2/show/NCT02407782)”

AbstractFind in source

“Our report followed the Consolidated Standards of Reporting Trials (CONSORT) guideline for parallel group randomised trials and its extension to non-inferiority and cluster trials.”

Methods ¶1Find in source

“Our study had some limitations. The generalisability of our results is restricted to patients without diffuse eczematisation or extensive impetiginisation.”

LimitationsFind in source

Registered (2 IDs: ClinicalTrials.gov, EudraCT). Reporting guideline cited: CONSORT.

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 42 references by DOI: 37 verified — 5 no DOI (shown, not verified).

2 data/code links checked; 2 live.

Copyediting

4 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 4 minor suggestions below.

4 copyedit issues flagged: mostly other, typo, grammar.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHrigor
Add supporting evidence for, or temper/remove, the Discussion claim that 'in other situations, first line oral ivermectin could be prescribed, especially when topical application is not practical' — the trial provides no efficacy data for nursing homes, prisons, or other settings where topical application is impractical, so the sentence should be flagged as an extrapolation or supported with cited external evidence.
An unsupported extrapolation beyond the studied population is the one substantive over-reach in an otherwise proportionally worded report, and the claim audit flagged it as under-evidenced.
2.
HIGHethics
Add an explicit statement in the Ethics section (e.g., in a correction/erratum) that the trial was conducted in accordance with the Declaration of Helsinki and ICH-GCP guidelines.
The Ethics section names the approving committees and registration but lacks the explicit framework-adherence statement, which is the basis of the ethical_approvals 'warn'.
3.
HIGHstatistics
Add a cluster-adjusted power re-analysis (design effect / intraclass correlation coefficient and effective power) as a supplementary analysis or correction, since the reported sample size calculation was 'standard (ie, without considering any clustering)' in a cluster-randomised trial.
Without an ICC-adjusted power estimate, readers cannot judge how much the ignored clustering reduced power for the failed non-inferiority primary outcome.
4.
MEDIUMcopyedit
Remove the duplicated word in the Results adverse-events sentence ('...potentially related to the study drug related...') and change 'of adverse events' to 'of participants' (14/142 and 20/147 are participant percentages).
The duplicated word is an obvious typo, and the mislabelled denominator could mislead a careful reader.
5.
MEDIUMcopyedit
Change the Table 3 column header 'Cures rate difference (percentage points (95% CI))' to 'Cure rate difference (percentage points (95% CI))' for consistency with the singular usage elsewhere in the table and text.
Inconsistent terminology in a key results table is easily caught by reviewers and detracts from an otherwise clean presentation.
6.
MEDIUMreporting
Add footnotes to Table 2 disclosing the two unstated missing values: the relationship-to-index-case categories sum to 420 vs the stated n=421, and the atopic-dermatitis rows sum to 363 vs n=365, with percentages computed from the smaller denominators.
These low-severity internal contradictions (flagged by the integrity check) are harmless if footnoted as missing data but look like arithmetic errors if left unexplained.
7.
MEDIUMreporting
Either add race/ethnicity to the baseline tables (if collected) or add a sentence in Methods or Limitations explaining why it is not reported (e.g., not routinely collected in France).
The demographics sub-criterion was marked reported_but_inadequate solely because race/ethnicity is absent; a justification closes the gap without new data.
8.
LOWstatistics
Add a sentence or supplement citing support for the robustness of the pre-specified mixed models (e.g., residual diagnostics or bootstrap sensitivity) so that model assumptions are verifiable.
R2 noted that mixed-model assumptions are not discussed; this is adequate for a pre-specified analysis model, but explicit diagnostics would strengthen verifiability.
9.
LOWreporting
Move or duplicate the manufacturer/source statement (ivermectin from MSD-Merck, permethrin from Codexial) from Competing interests into the Methods 'Intervention' section.
Readers should not need to consult the competing-interest statement to identify the source of the investigational products.
10.
LOWdata code
Clarify in the Data availability statement that the single Dryad DOI (10.5061/dryad.sn02v6xjd) contains both the dataset and the analysis code, or provide a separate code link.
Both URLs resolve and are content-consistent, so this is purely a clarity improvement for the shared data/code deposit.

Full text (47,789 chars)Analyzed: Aug 10, 2026