ScabiesPhase 3SCRATCHNCT02407782
Oral Ivermectin Versus Topical Permethrin to Treat Scabies in Children and Adults
A Phase 3 study testing Ivermectin and Permethrin in people with Scabies, run by University Hospital, Bordeaux at 29 sites in 2 countries.
Trial summary
Scabies remains a frequent condition that affects adults and children. The aim of this study is to compare the efficacy and safety of two drug treatments against scabies in children and their close contacts. One group will apply topical permethrin 5% and the other group will receive oral ivermectin. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Scabies
- What is being tested?
- Ivermectin and Permethrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,092 participants
- Where
- 29 sitesin 2 countries
- Study dates
- 19 Jan 2016to 18 Jan 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- children or adult
- For children, weight more than 15 kg
- Documented diagnosis of scabies, defined by positive dermoscopic examination.
Who cannot join
- Previous scabies therapy during the past 4 weeks
- Known allergy to ivermectin or permethrin
- Widespread eczematization or impetiginization
- Liver or renal failure
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
France28 sites
CHU d'Angers
Angers, Pays de la Loire Region, 49933
CH d'Argenteuil
Argenteuil, Île-de-France Region, 95107
APHP- Bobigny - Avicenne
Bobigny
CHU de Bordeaux Hôpital Pellegrin
Bordeaux, Aquitaine, 33000
CHU de Bordeaux - Saint André
Bordeaux
CHU de Brest
Brest
CHU de Lyon
Bron, Auvergne-Rhône-Alpes, 69677
CHG de Chalon sur Saône
Chalon-sur-Saône, Bourgogne-Franche-Comté, 71321
CHU de Créteil - Hôpital Henry Mondor
Créteil, Île-de-France Region, 94010
CHU de Dijon
Dijon, Bourgogne-Franche-Comté, 21079
CHI de Fréjus
Fréjus, Provence-Alpes-Côte d'Azur Region, 83600
CHD Vendée
La Roche-sur-Yon
CH Le Havre
Le Havre
CH du Mans
Le Mans, Pays de la Loire Region, 72037
CHRU de Lille
Lille
AP-HM
Marseille
CHU de Montpellier
Montpellier, Languedoc-Roussillon, 34295
CHU de Nantes
Nantes, Pays de la Loire Region, 44093
CHU de Nice
Nice, Provence-Alpes-Côte d'Azur Region, 06202
APHP Hôpital Cochin
Paris
AP-HP - Hôpital Robert Debré
Paris, Île-de-France Region, 75935
CH de Périgueux
Périgueux
CHU de Reims
Reims
CHU de Rennes
Rennes, Brittany Region, 35000
CHU de Rouen
Rouen
CHU de Saint-Etienne
Saint-Etienne
CHU de la Réunion
Saint-Pierre, Martinique, 97448
CHRU de Tours
Tours, Centre-Val de Loire, 37044
About this study
Official title: Oral Ivermectin Versus Topical Permethrin to Treat Scabies in Children and Adults: a Cluster Multicenter Randomized Trial
Scabies remains a frequent condition that affects adults and children. The aim of this study is to compare the efficacy and safety of two drug treatments against scabies in children and their close contacts. One group will apply topical permethrin 5% and the other group will receive oral ivermectin.
Both groups will be treated twice, once at inclusion and the second time 10 days later. Both treatment regimens have been used widely and are safe to use.
Read the detailed description
Scabies is a common condition, even in European countries, and the annual incidence seems to have increased over the past several years.
Children and infants represent one-third of patients with scabies. Diagnostic features comprise pruritus, skin burrows and the delta jet wing dermoscopic sign.
In many countries, topical permethrin is the first line therapy. Moreover, oral treatment with ivermectin represents an interesting alternative therapy, usually used as one dose of 200μg/kg, and more and more frequently recommended as two doses (one on day 1 and one between day 8 and day 15) without strong evidence. Management of scabies requires giving a treatment not only to the patient but also to the patient's close contacts.
The objective of our study is to compare efficacy and safety of topical permethrin applied twice at day 1 and day 10 versus oral ivermectin given twice at day 1 and day 10 to treat scabies in children and their close contacts. Children (2 to15 years) with scabies and their close contacts - or first circle- will be randomized 1:1 to receive permethrin or ivermectin.
A clinical follow-up will be performed 28 days (V2) and 56 days (V3) after the inclusion, including a dermatological examination and to collect safety data.
- Conditions
- Scabies
- Being tested
- Ivermectin, Permethrin
- Keywords
- Scabies, children, cluster, permethrin, Ivermectin, adults
- Medical subject headings
- Scabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvermectinDrug
oral ivermectin, 200μg/kg given at baseline and at day 10.
PermethrinDrug
topical permethrin 5% cream applied at baseline and at day 10.
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin | Experimental | Not described Receives: Drug: Ivermectin |
| Permethrin | Experimental | Not described Receives: Drug: Permethrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of skin lesions and healing at day 28
Healing of skin lesions and disappearance of pruritus at day 28 of the treatment in the cluster composed by the child and its close contacts
Measured: Day 28
Secondary outcomes (6)
Assessment of skin lesions and healing at day 56
Healing of skin lesions and disappearance of pruritus at day 56 of the treatment in the cluster composed by the child and its close contacts.
Measured: day 56
Assessment of skin lesions and healing at day 28 and 56 in children
Healing of skin lesions and disappearance of pruritus at day 28 and day 56 of the treatment in children
Measured: Day 28 and Day 56
Number of unaffected members in clusters treated by permethrin versus ivermectin at D0, D28 and D56.
Measured: day 0, day 28 and d56
Evaluation of delta wing jet sign(s) and mite egs
Measured: Day 56
Incidence of serious adverse events
Safety in both groups
Measured: Day 56
adherence of patients
Preference and adherence of patients in both groups
Measured: Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study start19 Jan 2016
- Primary completion16 Dec 2021
- Study completion18 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ScabiesStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,092 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruneau Giraudeau, Doctor, Study chair, Centre d'investigation clinique Inserm 1415 CHRU de Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407782
- Sponsor's protocol ID
- CHUBX 2011/16
- Acronym
- SCRATCH
- Status last verified
- Jun 2016
- First submitted
- 24 Mar 2015
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Boralevi F, Simon G, Bernigaud C, Brun J, Goujon E, Perrot JL, Phan A, Herisse 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, Labreze C, Miraglia G, Do-Pham G, Giraudeau B, Chosidow O. Oral ivermectin versus 5% permethrin cream to treat children and adults with classic scabies: multicentre, assessor blinded, cluster randomised clinical trial. BMJ. 2026 Jan 6;392:e086277. doi: 10.1136/bmj-2025-086277.
PubMed 41494769
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Ivermectin Versus Topical Permethrin to Treat Scabies in Children and Adults: a Cluster Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT02407782
- Acronym / sponsor ID
- SCRATCH / CHUBX 2011/16
- Conditions
- Scabies
- Keywords
- Scabies, children, cluster, permethrin, Ivermectin, adults
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,092 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 19 Jan 2016 (actual)
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Scabies remains a frequent condition that affects adults and children. The aim of this study is to compare the efficacy and safety of two drug treatments against scabies in children and their close contacts. One group will apply topical permethrin 5% and the other group will receive oral ivermectin.
Both groups will be treated twice, once at inclusion and the second time 10 days later. Both treatment regimens have been used widely and are safe to use.
Detailed description
Scabies is a common condition, even in European countries, and the annual incidence seems to have increased over the past several years.
Children and infants represent one-third of patients with scabies. Diagnostic features comprise pruritus, skin burrows and the delta jet wing dermoscopic sign.
In many countries, topical permethrin is the first line therapy. Moreover, oral treatment with ivermectin represents an interesting alternative therapy, usually used as one dose of 200μg/kg, and more and more frequently recommended as two doses (one on day 1 and one between day 8 and day 15) without strong evidence. Management of scabies requires giving a treatment not only to the patient but also to the patient's close contacts.
The objective of our study is to compare efficacy and safety of topical permethrin applied twice at day 1 and day 10 versus oral ivermectin given twice at day 1 and day 10 to treat scabies in children and their close contacts. Children (2 to15 years) with scabies and their close contacts - or first circle- will be randomized 1:1 to receive permethrin or ivermectin.
A clinical follow-up will be performed 28 days (V2) and 56 days (V3) after the inclusion, including a dermatological examination and to collect safety data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivermectin | Experimental | Drug: Ivermectin |
| Permethrin | Experimental | Drug: Permethrin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- children or adult
- For children, weight more than 15 kg
- Documented diagnosis of scabies, defined by positive dermoscopic examination.
Key exclusion criteria (4 listed)
- Previous scabies therapy during the past 4 weeks
- Known allergy to ivermectin or permethrin
- Widespread eczematization or impetiginization
- Liver or renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ivermectinoral ivermectin, 200μg/kg given at baseline and at day 10. | Drug | Ivermectin |
| Permethrintopical permethrin 5% cream applied at baseline and at day 10. | Drug | Permethrin |
Primary outcome
Assessment of skin lesions and healing at day 28
Time frame: Day 28
Healing of skin lesions and disappearance of pruritus at day 28 of the treatment in the cluster composed by the child and its close contacts
6 secondary outcomes
Assessment of skin lesions and healing at day 56
Time frame: day 56
Assessment of skin lesions and healing at day 28 and 56 in children
Time frame: Day 28 and Day 56
Number of unaffected members in clusters treated by permethrin versus ivermectin at D0, D28 and D56.
Time frame: day 0, day 28 and d56
Evaluation of delta wing jet sign(s) and mite egs
Time frame: Day 56
Incidence of serious adverse events
Time frame: Day 56
adherence of patients
Time frame: Day 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Derived from this study: PubMed 41494769Boralevi F, Simon G, Bernigaud C, Brun J, Goujon E, Perrot JL, Phan A, Herisse 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, Labreze C, Miraglia G, Do-Pham G, Giraudeau B, Chosidow O. Oral ivermectin versus 5% permethrin cream to treat children and adults with classic scabies: multicentre, assessor blinded, cluster randomised clinical trial. BMJ. 2026 Jan 6;392:e086277. doi: 10.1136/bmj-2025-086277.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruneau Giraudeau, Doctor study chair
Centre d'investigation clinique Inserm 1415 CHRU de Tours
29 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ivermectin and Permethrin in people with Scabies, run by University Hospital, Bordeaux at 29 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in France, Guadeloupe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of skin lesions and healing at day 28 (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02407782, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.