GalePhase 3GALECRUSTEDNCT02841215
Efficacy Study Between Two Different Dosages of an Antiparasitic in Patients With Crusted Scabies
A Phase 3 study testing Ivermectin 200 µg/kg and Ivermectin 400 µg/kg in people with Gale and Severe Forms of Scabies, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Severe forms of scabies (crusted scabies and profuse scabies) require a specific treatment. Ivermectin is a recommended treatment in common forms of scabies and represents a promising treatment in crusted scabies in case reports. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gale, Severe Forms of Scabies, Oral Parasitic Drug
- What is being tested?
- Ivermectin 200 µg/kg and Ivermectin 400 µg/kg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteFrance
- Study dates
- 11 Oct 2017to 12 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years old, diagnosed with severe forms of scabies
- clinical criteria : cutaneous lesions of scabies
- crusted scabies: at least two sites of hyperkeratosis will define crusted scabies and/or
- profuse scabies : spreading lesions with erythematous scaly eruption of the neck, face or trunk without hyperkeratosis
- paraclinical criteria:
- Positive parasitological test
- and/or dermoscopic exam with signs of scabies
- Effective contraception for women in age of pregnancy Written consent from patient or his/her legal representant, trustworthy person or family member Affiliated to a social security scheme
Who cannot join
- Pregnant and/or breastfeeding women
- Intolerance to ivermectin or topical treatment (permethrin 5% cream) or emollient cream
- Use of anti parasitic drug (ivermectin or albendazole) within the past 7 days
- Abnormal liver test results: ALT and/or AST >3N within the past 7 days (within 6 months if no hepatic history)
- Participation in other biomedical drug research
- Patient deprived of freedom
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Double-blind Trial Assessing the Efficacy of a 400µg/kg Ivermectin /5% Permethrin / Emollient Cream Regimen in Patients With Crusted Scabies as Compared to a 200µg/kg Ivermectin /5% Permethrin /Emollient Cream Regimen
Severe forms of scabies (crusted scabies and profuse scabies) require a specific treatment. Ivermectin is a recommended treatment in common forms of scabies and represents a promising treatment in crusted scabies in case reports. However, response to ivermectin remains variable among studies, and there is no consensus on the schemes to adopt (dosages and administrations). Ivermectin at 400 µg/kg has already been used, without showing toxicity (in head lice treatment in particular). Investigators propose to demonstrate that 400µg/kg ivermectin dosage will show better efficacy than a 200µg/kg in patients with severe forms of scabies (crusted and profuse).
- Conditions
- Gale, Severe Forms of Scabies, Oral Parasitic Drug, Ivermectin
- Being tested
- Ivermectin 200 µg/kg, Ivermectin 400 µg/kg
- Keywords
- Gale, Severe forms of scabies, Oral parasitic drug, Ivermectin
- Medical subject headings
- Galactosemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivermectin 200 µg/kgDrug
Oral ivermectin 200 µg/kg three times (D0, D7 and D14) + topical treatment (permethrin 5% cream) on skin, hair and genital organs (D0 and D7) + emollient cream (Dexeryl® or other) daily on skin (D0 to D28)
Ivermectin 400 µg/kgDrug
Oral ivermectin 400 µg/kg three times (D0, D7 and D14) + topical treatment (permethrin 5% cream) on skin, hair and genital organs (D0 and D7) + emollient cream (Dexeryl® or other)daily on skin (D0 to D28)
| Study group | Role | What they receive |
|---|---|---|
| Oral ivermectin 400 µg/kg | Experimental | Oral ivermectin 400 µg/kg + topical treatment (permethrin 5% cream) + emollient cream (Dexeryl® or other) Receives: Drug: Ivermectin 400 µg/kg |
| Oral ivermectin 200 µg/kg | Active comparator | Oral ivermectin 200 µg/kg + topical treatment (permethrin 5% cream) + emollient cream (Dexeryl® or other) Receives: Drug: Ivermectin 200 µg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of a successful treatment defined by : -Two negative parasitologic and/or two dermoscopic exams
Parasitologic and/or dermoscopic exams will be perform at days 18 +/-2days and at days 21+/-2 days
Measured: Days 21+/-2 days
Rate of a successful treatment defined by : - A clinical response : disappearance of clinical active lesions
Measured: Days 28+/- 2 days
Secondary outcomes (1)
Rate of adverse effects
Measured: Days 18 +/-2 days, Days 21+/-2 days and Days 28+/-2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study start11 Oct 2017
- Primary completion12 Jan 2022
- Study completion12 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 GaleStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giao DO-PHAM, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841215
- Sponsor's protocol ID
- P140939
- Acronym
- GALECRUSTED
- Status last verified
- Sep 2023
- First submitted
- 30 Jun 2016
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bernigaud C, Do-Pham G, Guichard E, Beylot-Barry M, Goujon E, Isnard C, Beneton N, Samimi M, Tedbirt B, Adamski H, Azib S, Mahe E, Michel C, Perrot JL, Acquitter M, Bursztejn AC, Chaby G, Caux F, Passeron T, Vanhaecke C, Mahe A, Leccia MT, Barbarot S, Lenormand C, Aubin F, Foulet F, Gregoire L, Giraudeau B, Chosidow O. Combined Oral Ivermectin and 5% Permethrin Cream to Treat Severe Scabies. N Engl J Med. 2026 May 7;394(18):1814-1823. doi: 10.1056/NEJMoa2411721.
PubMed 42090793
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Double-blind Trial Assessing the Efficacy of a 400µg/kg Ivermectin /5% Permethrin / Emollient Cream Regimen in Patients With Crusted Scabies as Compared to a 200µg/kg Ivermectin /5% Permethrin /Emollient Cream Regimen
- ClinicalTrials.gov ID
- NCT02841215
- Acronym / sponsor ID
- GALECRUSTED / P140939
- Conditions
- Gale, Severe Forms of Scabies, Oral Parasitic Drug, Ivermectin
- Keywords
- Gale, Severe forms of scabies, Oral parasitic drug, Ivermectin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 12 Jan 2022 (actual)
- First posted
- 22 Jul 2016 (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.
Severe forms of scabies (crusted scabies and profuse scabies) require a specific treatment. Ivermectin is a recommended treatment in common forms of scabies and represents a promising treatment in crusted scabies in case reports. However, response to ivermectin remains variable among studies, and there is no consensus on the schemes to adopt (dosages and administrations). Ivermectin at 400 µg/kg has already been used, without showing toxicity (in head lice treatment in particular). Investigators propose to demonstrate that 400µg/kg ivermectin dosage will show better efficacy than a 200µg/kg in patients with severe forms of scabies (crusted and profuse).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral ivermectin 400 µg/kg | Experimental | Drug: Ivermectin 400 µg/kgOral ivermectin 400 µg/kg + topical treatment (permethrin 5% cream) + emollient cream (Dexeryl® or other) |
| Oral ivermectin 200 µg/kg | Active comparator | Drug: Ivermectin 200 µg/kgOral ivermectin 200 µg/kg + topical treatment (permethrin 5% cream) + emollient cream (Dexeryl® or other) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients ≥ 18 years old, diagnosed with severe forms of scabies
- clinical criteria : cutaneous lesions of scabies
- paraclinical criteria:
- Effective contraception for women in age of pregnancy Written consent from patient or his/her legal representant, trustworthy person or family member Affiliated to a social security scheme
Key exclusion criteria (7 listed)
- Pregnant and/or breastfeeding women
- Intolerance to ivermectin or topical treatment (permethrin 5% cream) or emollient cream
- Use of anti parasitic drug (ivermectin or albendazole) within the past 7 days
- Abnormal liver test results: ALT and/or AST >3N within the past 7 days (within 6 months if no hepatic history)
- Participation in other biomedical drug research
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 |
|---|---|---|
| Ivermectin 200 µg/kgOral ivermectin 200 µg/kg three times (D0, D7 and D14) + topical treatment (permethrin 5% cream) on skin, hair and genital organs (D0 and D7) + emollient cream (Dexeryl® or other) daily on skin (D0 to D28) | Drug | Oral ivermectin 200 µg/kg |
| Ivermectin 400 µg/kgOral ivermectin 400 µg/kg three times (D0, D7 and D14) + topical treatment (permethrin 5% cream) on skin, hair and genital organs (D0 and D7) + emollient cream (Dexeryl® or other)daily on skin (D0 to D28) | Drug | Oral ivermectin 400 µg/kg |
Primary outcome
Rate of a successful treatment defined by : -Two negative parasitologic and/or two dermoscopic exams
Time frame: Days 21+/-2 days
Parasitologic and/or dermoscopic exams will be perform at days 18 +/-2days and at days 21+/-2 days
Rate of a successful treatment defined by : - A clinical response : disappearance of clinical active lesions
Time frame: Days 28+/- 2 days
1 secondary outcome
Rate of adverse effects
Time frame: Days 18 +/-2 days, Days 21+/-2 days and Days 28+/-2 days
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 22 Sep 2023.
- Derived from this study: PubMed 42090793Bernigaud C, Do-Pham G, Guichard E, Beylot-Barry M, Goujon E, Isnard C, Beneton N, Samimi M, Tedbirt B, Adamski H, Azib S, Mahe E, Michel C, Perrot JL, Acquitter M, Bursztejn AC, Chaby G, Caux F, Passeron T, Vanhaecke C, Mahe A, Leccia MT, Barbarot S, Lenormand C, Aubin F, Foulet F, Gregoire L, Giraudeau B, Chosidow O. Combined Oral Ivermectin and 5% Permethrin Cream to Treat Severe Scabies. N Engl J Med. 2026 May 7;394(18):1814-1823. doi: 10.1056/NEJMoa2411721.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Giao DO-PHAM, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ivermectin 200 µg/kg and Ivermectin 400 µg/kg in people with Gale and Severe Forms of Scabies, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 8 inclusion and 7 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 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Rate of a successful treatment defined by : -Two negative parasitologic and/or two dermoscopic exams (time frame: Days 21+/-2 days). The study lists 2 primary outcomes in all. 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 NCT02841215, 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 22 Sep 2023.