DOI: 10.5061/dryad.sn02v6xjd
title: Oral ivermectin versus 5% permethrin cream to treat children and adults with classic scabies: multicenter, assessor-blinded, cluster-randomised clinical trial

description: OBJECTIVE With regards to the existing controversial data (Cochrane
 reviews, network meta-analysis) in classic scabies, to investigate whether
 oral ivermectin or topical 5% permethrin clinically cure scabies in index
 cases and his/her households. DESIGN Multicenter, assessor-blinded,
 cluster-randomised non-inferiority trial with a possible switch to
 superiority. SETTING 28 French hospitals between January 2016 and December
 2021. PARTICIPANTS Adults and children &gt;15 kg, with
 dermoscopy-confirmed scabies—index cases— INTERVENTIONS Index cases were
 randomly assigned to either the ivermectin group or permethrin group (1:1
 ratio). Each cluster member, defined as each index-case’s household,
 received the same treatment as the index case (except for children
 &lt;15 kg, all prescribed 5% permethrin). All participants received on
 day (D)0 and D10, either oral 200-µg/kg ivermectin or 5% permethrin cream,
 applied head-to-toe. MAIN OUTCOME MEASURES Primary outcome was D28
 clinical cure of the cluster, i.e., disappearance of scabies clinical
 signs/symptoms for all the cluster members. Secondary outcomes included
 index-case and individual-level analyses and safety. Blinded
 Dermatologists were used as assessors. RESULTS The main analysis included
 507 ivermectin-treated participants, comprising 142 index
 cases-households, and 568 permethrin-treated participants, comprising 147
 index cases-households. Their respective cluster-level cure rates were
 71.8% vs. 88.5% (–16.7 percentage-point difference, [95% CI, –26.3 to
 –7.1]. Secondary outcome percentage-point differences also showed
 ivermectin inferiority to 5% permethrin for index cases** **76.6% vs.
 91.5%; –14.9 percentage-point difference [–23.6 to –6.2] and participants:
 85.3% vs. 94.2%; –9.2 percentage-point difference [–14.9 to –3.5]),
 respectively. Intraclass-correlation coefficients were higher for
 permethrin than ivermectin for all clusters (0.68 [0.61 to 0.75]
 vs. 0.46 [0.37 to 0.56] and cluster size &gt;1 (0.67
 [0.60 to 0.74] vs. 0.47 [0.37 to 0.56]). Cutaneous
 adverse events occurred in 11.9% and 15.6% of ivermectin and permethrin
 participants, respectively. CONCLUSIONS In this first cluster-randomised
 trial in dermoscopy-confirmed classic scabies designed, we did not
 demonstrate the non-inferiority of D0+D10 oral ivermectin to 5% permethrin
 cream to obtain D28 clinical scabies cures of index cases-households.
 Conversely, a statistical superiority of 5% permethrin was shown.
description: # Oral ivermectin versus 5% permethrin cream to treat children and adults
 with classic scabies: multicenter, assessor-blinded, cluster-randomised
 clinical trial Dataset DOI:
 [10.5061/dryad.sn02v6xjd](https://doi.org/10.5061/dryad.sn02v6xjd) ##
 Description of the data and file structure Paper: Oral Ivermectin versus
 5% Permethrin Cream to Treat Children and Adults with Classic Scabies:
 multicenter, assessor-blinded, cluster-randomised clinical trial  
 Authors: Franck Boralevi (deceased) et al Corresponding author: Olivier
 Chosidow Contact: Bruno Giraudeau
 [bruno.giraudeau@univ-tours.fr](mailto:bruno.giraudeau@univ-tours.fr)  
 Description: This README file describes the data package accompanying the
 above publication. The SCRATCH study was a French randomized trial. Data
 were collected using a case report form (CRF). Files: Data bases: there
 are 7 data files. The first 3 data bases correspond do data collected via
 the CRF while the trial was ongoing. Some comments have to be made:
 -        only some of the collected data are in the enclosed data bases,
 i.e., those necessary to reproduce the results reported in Table 3 of the
 manuscript that is to say the results related to the outcome -       
 there is no direct identifiers in the datasets. Regarding indirect
 identifiers, we do need to keep the sex variable (which is used in the
 multiple imputation approach), we also do need to keep a cluster (i.e.
 household) identifier, which is necessary for the statistical analysis.
 Other indirect identifiers have been dropped out -        participants
 identifiers have been changed The RANDOMISATION.csv file corresponds to
 the a priori randomisation sequences (i.e., which were generated before
 the beginning of the trial); the OUTCOME_and_COMPLIANCE.csv file
 corresponds to the a posteriori adjudicated primary outcome and compliance
 status (i.e., which were derived once the trial was finished). As for
 tables ORDERCLU.csv and ORDERIND.csv they are useful to re-run the
 statistical analysis. Indeed, subject and cluster identifications have
 been changed (to avoid any possibility to re-identify a participant), thus
 leading to changes in the way tables are ordered when used for the
 statistical analysis. However, the statistical analysis uses the SAS PROC
 MI which is sensitive to the order among participants. Differences are
 very small, but to recover the exact figures reported in the article, we
 considered it was better to have data sorted in the same way as they have
 been initially analysed. The two tables ORDERCLU.csv and ORDERIND.cvs
 allow achieving this. Missing data were not replaced. This allows running
 the SAS program (enclosed) without any trouble. Under "Format",
 the number after $ shows the maximum length (in characters) of the
 variable.   ### Files and variables #### 1.       RND.csv: data associated
 to the index case characteristics | 
 
 | 
 
 | 
 
 | 
 
 | 
 
 | | :----- | :-------------------- | :------- | :--------- |
 :----------------------------------------------------------------- | |
 **#** | **Variable** | **Type** | **Format** | **Label** | | **1** |
 clePat | Texte | $6. | Patient identification number | | **2** |
 rndNbPerClus | Num. | NBPERS. | Number of persons in the cluster
 (including the index case) | | **3** | rndPatTyp | Num. | TYPPAT. | Type
 of patient | | **4** | rndAgeMoi | Num. | 4. | Age of the index case
 (months) | | **5** | rndAgeAnn | Num. | 3. | Age of the index case (years)
 | | **6** | rndDelAppSigGal | Num. | 3. | Delay in onset of first scabies
 symptoms (days) | | **7** | rndDelAppSigGalNa | Num. | COCHE. | Delay in
 onset of first scabies symptoms: NA (if asymptomatic) | | **8** |
 rndTttGal12Moi | Num. | YESNO. | Scabies treatment in the past 12 months |
 | **9** | rndTttGalNb | Num. | NBTRA. | Number of scabies treatments in
 the past 12 months | | **10** | rndTttGalTypIver | Num. | COCHE. | Scabies
 treatments in the past 12 months: Ivermectin | | **11** | rndTttGalTypPerm
 | Num. | COCHE. | Scabies treatments in the past 12 months: Permethrin | |
 **12** | rndTttGalTypBenz | Num. | COCHE. | Scabies treatments in the past
 12 months: Benzyl benzoate | | **13** | rndTttGalTypEsde | Num. | COCHE. |
 Scabies treatments in the past 12 months: Esdepallethrin | | **14** |
 rndTttGalTypCrot | Num. | COCHE. | Scabies treatments in the past 12
 months: Crotamiton | | **15** | rndTttGalTypAut | Num. | COCHE. | Scabies
 treatments in the past 12 months: Other | | **16** | rndTttGalAutPrec |
 Texte | $255. | Scabies treatments in the past 12 months: Other (specify)
 | | **17** | rndAtcdAllIve | Num. | YESNO. | History of allergy to
 ivermectin | | **18** | rndAtcdAllPer | Num. | YESNO. | History of allergy
 to permethrin | | **19** | rndAtcdInsHep | Num. | YESNO. | History of
 hepatic failure | | **20** | rndAtcdInsRen | Num. | YESNO. | History of
 renal failure | | **21** | rndExaPhyEcz | Num. | YESNO. | Eczema | |
 **22** | rndExaPhyImp | Num. | YESNO. | Impetiginization | | **23** |
 rndCriIncAge | Num. | YESNO. | Child or adult | | **24** | rndCriIncPoi |
 Num. | YESNO. | Weight of the child (index case) greater than 15 kg | |
 **25** | rndCriIncExaDerPos | Num. | YESNO. | Positive dermoscopic
 examination | | **26** | rndCriIncAffSecu | Num. | YESNO. | Child covered
 by the national health insurance | | **27** | rndCriIncProSuiEtu | Num. |
 YESNO. | Relatives willing to complete the full study | | **28** |
 rndCriIncConSign | Num. | YESNO. | Written informed consent signed by
 persons with parental authority | | **29** | rndCriExAge | Num. | YESNO. |
 Child (index case) younger than 2 months | | **30** | rndCriExAllIver |
 Num. | YESNO. | Known allergy to ivermectin or any of its components | |
 **31** | rndCriExAllPerm | Num. | YESNO. | Known allergy to permethrin or
 any of its components | | **32** | rndCriExTttAntSca | Num. | YESNO. |
 Antiscabies treatment less than 4 weeks ago | | **33** | rndCriExEczImpDif
 | Num. | YESNO. | Diffuse eczema or impetiginization | | **34** |
 rndCriExInsHepRen | Num. | YESNO. | Known severe hepatic or renal failure
 | | **35** | rndCriIncClusNb | Num. | YESNO. | Cluster composed of no more
 than 6 persons | | **36** | rndCriIncClusAge | Num. | YESNO. | Youngest
 member aged at least 2 months | | **37** | rndCriIncClusAffSecu | Num. |
 YESNO. | National health insurance coverage for all cluster members | |
 **38** | rndCriIncClusConSign | Num. | YESNO. | Written informed consent
 signed by all adult cluster members | | **39** | rndCriIncClusSuiEtu |
 Num. | YESNO. | Willingness of all cluster members to complete the full
 study | | **40** | rndCriExClusAge | Num. | YESNO. | One of the members
 younger than 2 months | | **41** | rndCriExClusAllIver | Num. | YESNO. |
 Known allergy to ivermectin or any of its components | | **42** |
 rndCriExClusAllPerm | Num. | YESNO. | Known allergy to permethrin or any
 of its components | | **43** | rndCriExClusTttAntSca | Num. | YESNO. |
 Antiscabies treatment less than 4 weeks ago | | **44** |
 rndCriExClusEczImpDif | Num. | YESNO. | Diffuse eczema or impetiginization
 | | **45** | rndCriExClusInsHepRen | Num. | YESNO. | Known severe hepatic
 or renal failure | | **46** | rndAttBraTtt | Num. | TTT. | Treatment arm
 assignment | 
 
 #### 2.       RNDCLU.csv: data associated to the cluster members
 characteristics | 
 
 | 
 
 | 
 
 | 
 
 | 
 
 | | :----- | :------------------- | :------- | :--------- |
 :-------------------------------------------------------------------------
 | | **#** | **Variable** | **Type** | **Format** | **Label** | | **1** |
 clePat | Texte | $6. | Patient identification number | | **2** |
 rndcluPatPresMem | Num. | PRESABS. | Presence of cluster member at visit |
 | **3** | rndcluPatTyp | Num. | TYPPAT. | Type of patient | | **4** |
 rndcluNum | Texte | $6. | Cluster member identification number | | **5** |
 rndcluAgeAnn | Num. | 3. | Age (in years) | | **6** | rndcluAgeMoi | Num.
 | 2. | Age (in months) | | **7** | rndcluDelAppSigGal | Num. | 3. | Time
 to onset of first scabies symptoms (in days) | | **8** |
 rndcluDelAppSigGalNa | Num. | COCHE. | Time to onset of first scabies
 symptoms – not applicable (if asymptomatic) | | **9** | rndcluTttGal12Moi
 | Num. | YESNO. | Treatment for scabies in the past 12 months | | **10** |
 rndcluTttGalNb | Num. | NBTRA. | Number of treatments for scabies in the
 past 12 months | | **11** | rndcluTttGalTypIver | Num. | COCHE. |
 Treatments for scabies in the past 12 months – Ivermectin | | **12** |
 rndcluTttGalTypPerm | Num. | COCHE. | Treatments for scabies in the past
 12 months – Permethrin | | **13** | rndcluTttGalTypBenz | Num. | COCHE. |
 Treatments for scabies in the past 12 months – Benzyl benzoate | | **14**
 | rndcluTttGalTypEsde | Num. | COCHE. | Treatments for scabies in the past
 12 months – Esdepallethrin | | **15** | rndcluTttGalTypCrot | Num. |
 COCHE. | Treatments for scabies in the past 12 months – Crotamiton | |
 **16** | rndcluTttGalTypAut | Num. | COCHE. | Treatments for scabies in
 the past 12 months – Other | | **17** | rndcluTttGalAutPrec | Texte |
 $255. | Treatments for scabies in the past 12 months – Other (specify) | |
 **18** | rndcluAtcdAllIve | Num. | YESNO. | History of allergy to
 ivermectin | | **19** | rndcluAtcdAllPer | Num. | YESNO. | History of
 allergy to permethrin | | **20** | rndcluAtcdInsHep | Num. | YESNO. |
 History of hepatic insufficiency | | **21** | rndcluAtcdInsRen | Num. |
 YESNO. | History of renal insufficiency | | **22** | rndcluExaPhyEcz |
 Num. | YESNO. | Eczematization | | **23** | rndcluExaPhyImp | Num. |
 YESNO. | Impetiginization | 
 
 #### 3.       INCLUSION.csv: data collected during the inclusion visit
 for both the index cases and cluster members | 
 
 | 
 
 | 
 
 | 
 
 | 
 
 | | :----- | :------------ | :------- | :--------- |
 :--------------------------------- | | **#** | **Variable** | **Type** |
 **Format** | **Label** | | **1** | ClePat | 10 | $6. | Patient
 identification number | | **2** | IncSex | 8 | SEX. | Sex | | **3** |
 IncCluPresMem | 8 | PRESABS. | Household member present or absent | |
 **4** | Age | 8 | BEST12. | Age | | **5** | Prurit | 8 | YESNO. | Presence
 of prurit | 
 
 #### 4.       RANDOMISATION.csv: this file displays the randomisation
 sequences | 
 
 | 
 
 | 
 
 | 
 
 | 
 
 | | :----- | :----------- | :------- | :--------- |
 :---------------------------- | | **#** | **Variable** | **Type** |
 **Format** | **Label** | | **1** | listRanTtt | Texte | $12. | Treatment A
 or B | | **2** | listRanProd | Texte | $11. | Treatment name | | **3** |
 ClePat | Texte. | $4. | Patient identification number | 
 
 #### 5.       OUTCOME_AND_COMPLIANCE.csv: this file displays the
 adjudicated primary outcome as well as the compliance status | 
 
 | 
 
 | 
 
 | 
 
 | 
 
 | | :----- | :--------------------- | :------- | :--------- |
 :--------------------------------------------- | | **#** | **Variable** |
 **Type** | **Format** | **Label** | | **1** | ClePat | Texte | $6. |
 Patient identification number | | **2** | Cluster | Num. | BEST12. |
 Cluster identification number | | **3** | Compliance\_Cluster | Texte |
 $4. | Compliance status - Cluster level | | **4** | Compliance\_Individuel
 | Texte | $9. | Compliance status - Individual level | | **5** |
 Outcome\_Cluster | Texte | $5. | Adjudicated primary outcome - Cluster
 level | | **6** | Outcome\_Individuel | Texte | $5. | Adjudicated primary
 outcome - Individual level | 
 
 #### 6.       ORDERCLU.csv: this file displays the original order among
 clusters, thus allowing to recover the exact result reported in the
 article. Indeed, the SAS MI procedure is slightly sensitive to the order |
 
 
 | 
 
 | 
 
 | 
 
 | 
 
 | | :----- | :----------- | :------- | :--------- |
 :---------------------------- | | **#** | **Variable** | **Type** |
 **Format** | **Label** | | **1** | ClePat | Texte | $4. | Patient
 identification number | | **2** | Order | Num. | BEST12. | Initial cluster
 order | 
 
 #### 7.       ORDERIND.csv: this file displays the original order among
 individuals, thus allowing to recover the exact result reported in the
 article. Indeed, the SAS MI procedure is slightly sensitive to the order |
 
 
 | 
 
 | 
 
 | 
 
 | 
 
 | | :----- | :----------- | :------- | :--------- |
 :---------------------------- | | **#** | **Variable** | **Type** |
 **Format** | **Label** | | **1** | ClePat | Texte | $4. | Patient
 identification number | | **2** | Order | Num. | BEST12. | Initial
 individual order | ## Code/software  The statistical analysis of the
 SCRATCH trial has been performed using SAS. Below are the SAS formats of
 the variables previously listed. These formats are also in the
 2025_10_24_SCRATCH_Format.txt SAS program. | 
 
 | 
 
 | | :------------------------ | :--------------- | | value yesno
 (NOTSORTED) | 
 
 | | 
 
 | 0 = "No" | | 
 
 | 1 = "Yes" | | 
 
 | . = "Unknown"; | | 
 
 | 
 
 | | value ttt (NOTSORTED) | 
 
 | | 
 
 | 1 = "Ivermectin" | | 
 
 | 2 = "Permethrin" | | 
 
 | . = "Unknown"; | | 
 
 | 
 
 | | value coche (NOTSORTED) | 
 
 | | 
 
 | 1 = "Yes" | | 
 
 | . = "Unchecked"; | | 
 
 | 
 
 | | value nbPers (NOTSORTED) | 
 
 | | 
 
 | 2 = "2" | | 
 
 | 3 = "3" | | 
 
 | 4 = "4" | | 
 
 | 5 = "5" | | 
 
 | 6 = "6" | | 
 
 | 7 = "7" | | 
 
 | 8 = "8" | | 
 
 | 9 = "9" | | 
 
 | 10 = "10" | | 
 
 | . = "Unknown"; | | 
 
 | 
 
 | | value typPat (NOTSORTED) | 
 
 | | 
 
 | 1 = "Child" | | 
 
 | 2 = "Adult" | | 
 
 | . = "Unknown"; | | 
 
 | 
 
 | | value nbTra (NOTSORTED) | 
 
 | | 
 
 | 1 = "1" | | 
 
 | 2 = "2" | | 
 
 | 3 = "3 - 4" | | 
 
 | 4 = "5 and more" | | 
 
 | . = "Unknown"; | | 
 
 | 
 
 | | value presAbs (NOTSORTED) | 
 
 | | 
 
 | 0 = "Absent" | | 
 
 | 1 = "Present" | | 
 
 | . = "Unknown"; | | 
 
 | 
 
 | | value sex (NOTSORTED) | 
 
 | | 
 
 | 1 = "Male" | | 
 
 | 2 = "Female" | | 
 
 | . = "Unknown"; | 
 
 Finally, the following SAS programs are provided: 1.      
 2025_10_24_IMPORT.txt: this program allows creating SAS databases using
 the 12 data bases and the program 2025_10_24_SCRATCH_Formats.txt 2.      
 2025_10_24_Primary_Outcome_Cluster.txt
 2025_10_24_Primary_Outcome_Index_Case.txt
 2025_10_24_Primary_Outcome_Individual.txt These 3 files report the SAS
 statistical program used to obtain the main results of the referenced
 publication (reported in Table 3)   To reproduce the statistical analysis:
 1.       Create a directory in which you upload all the programs 2.      
 Change the extension of the 2025_10_24_SCRATCH_Format.txt file such that
 it becomes a SAS program 3.       Change the extension of the
 2025_10_24_IMPORT.txt file such that it becomes a SAS program. Run it,
 such that the SAS tables are created /!\ Be aware that directories have to
 be changed in the program 4.       Change the extension of the
 2025_10_24_Primary_Outcome_Cluster.txt and run it to obtain the cluster
 level analysis result /!\ Be aware that directories have to be changed in
 the program 5.       Change the extension of the
 2025_10_24_Primary_Outcome_Index_Case.txt and run it to obtain the index
 case analysis result /!\ Be aware that directories have to be changed in
 the program 6.       Change the extension of the
 2025_10_24_Primary_Outcome_Individual.txt and run it to obtain the
 individual level analysis result /!\ Be aware that directories have to be
 changed in the program ## Human subjects data We confirm that we received
 informed consent from all participants. There is no identifiable
 information in the data sets which is a requirement to conduct clinical
 research in France. We changed identification numbers and drop all the
 days from the data bases.