A Phase 2 interventional study of Moxidectin Oral Product and Moxidectin Oral Product in Scabies, sponsored by Medicines Development for Global Health. Completed at 9 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Medicines Development for Global Health · Phase 2, Interventional, and Treatment
Moxidectin is not approved to treat scabies in humans. The effective dose of moxidectin to treat scabies is not known. This study aims to assess the efficacy of a single administration of 8 mg, 16 mg, or 32 mg moxidectin per oral in achieving Scabies Complete Cure at Day 28. This study also aims to assess the safety of three strengths of single moxidectin doses in adults with scabies.
51 studies on the registry are indexed under Scabies; 10 are open to participants now.
This study's enrollment of 200 is close to the median of 183 across 41 interventional studies indexed under Scabies.
Browse Scabies studies →Medicines Development for Global Health is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Moxidectin 8 mg (over encapsulated) will be administered as a single dose on Day 0. Each subject will receive the same number of capsules made up of moxidectin 2 mg over encapsulated tablets and placebo capsules to maintain the blind.
Drug: Moxidectin Oral Product
Moxidectin 16 mg (over encapsulated) will be administered as a single dose on Day 0. Each subject will receive the same number of capsules made up of moxidectin 2 mg over encapsulated tablets and placebo capsules to maintain the blind.
Drug: Moxidectin Oral Product
Moxidectin 32 mg (over encapsulated) will be administered as a single dose on Day 0.
Drug: Moxidectin Oral Product
16 Placebo capsules will be administered as a single dose on Day 0.
Drug: Placebo
The required number of moxidectin 2 mg tablet over encapsulated capsules will be administered as a single dose with placebo capsules to match as required
The required number of moxidectin 2 mg tablet over encapsulated capsules will be administered as a single dose with placebo capsules to match as required
The required number of moxidectin 2 mg tablet over encapsulated capsules will be administered as a single dose.
16 placebo capsules will be administered as a single dose.
Percentage of Index Subjects Achieving Complete Cure (Efficacy)
Complete Cure is defined as demonstration of both: 1. Clinical cure: all signs and symptoms have completely resolved, including burrows, inflammatory/noninflammatory lesions and pruritus. And 2. Microscopic or dermatoscopic cure demonstrating the absence of mites, eggs, and/or scybala, and negative dermoscopy for burrows.
Time frame: 28 Days
Incidence and Severity of Treatment Emergent Adverse Event (Safety)
Incidence and severity of Treatment Emergent Adverse Event (TEAEs), Incidence of serious TEAEs and Incidence of TEAEs leading to study withdrawal and/or death. The analysis of adverse events (AEs) was focused on treatment emergent adverse events (TEAEs), defined as AEs that started, or worsened, on or after the start of the administration of IP.
Time frame: Day 0 to Week 16 inclusive.
Percentage of Subjects Achieving Day 28 Cure Rates: Clinical Cure
The Percentage of index subjects demonstrating clinical cure without microscopic or dermatoscopic cure at Day 28, assessed by skin examination to confirm all signs of scabies have completely resolved.
Time frame: 28 Days
Percentage of Subjects Achieving Day 28 Cure Rates: Microscopic or Dermatoscopic Cure Without Clinical Cure.
The Percentage of index subjects demonstrating microscopic or dermatoscopic cure without clinical cure at Day 28. Microscopic or dermatoscopic cure is assessed by demonstrating the absence of scabies mites, eggs, and/or scybala, and negative dermoscopy for burrows.
Time frame: 28 Days
Percentage of Subjects Reporting Day 28 Cure Rates: Investigator Assessed Cure
The Percentage of index subjects demonstrating cure as assessed by the Investigator at Day 28.
Time frame: Day 28
The study was open to recruitment on 9 Nov 2023 and the first participant was screened on 14 Nov 2023. Last participant last study visit was completed on 11 Feb 2025.
| Milestone | Moxidectin 8mg | Moxidectin 16mg | Moxidectin 32mg | Placebo |
|---|---|---|---|---|
| Started | 50 | 50 | 51 | 49 |
| Full analysis set | 50 | 49 | 51 | 49 |
| Per protocol analysis set | 49 | 47 | 51 | 48 |
| Safety analysis set | 50 | 49 | 51 | 49 |
| Complete analysis set | 50 | 48 | 51 | 48 |
| Completed | 50 | 48 | 50 | 48 |
| Not completed | 0 | 2 | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 | 1 | 1 |
| Withdrew: Withdrawal prior to dosing | 0 | 1 | 0 | 0 |
Complete Cure is defined as demonstration of both: 1. Clinical cure: all signs and symptoms have completely resolved, including burrows, inflammatory/noninflammatory lesions and pruritus. And 2. Microscopic or dermatoscopic cure demonstrating the absence of mites, eggs, and/or scybala, and negative dermoscopy for burrows.
| Participants | Moxidectin 8mg | Moxidectin 16mg | Moxidectin 32mg | Placebo |
|---|---|---|---|---|
| Percentage of Index Subjects Achieving Complete Cure (Efficacy) | 28 | 31 | 32 | 1 |
Incidence and severity of Treatment Emergent Adverse Event (TEAEs), Incidence of serious TEAEs and Incidence of TEAEs leading to study withdrawal and/or death. The analysis of adverse events (AEs) was focused on treatment emergent adverse events (TEAEs), defined as AEs that started, or worsened, on or after the start of the administration of IP.
| participants | Moxidectin 8mg | Moxidectin 16mg | Moxidectin 32mg | Placebo |
|---|---|---|---|---|
| Number of Participants with one or more Treatment Emergent Adverse Events (TEAEs) | 9 | 5 | 11 | 8 |
| Number of Participants with Grade 1 TEAE | 7 | 4 | 7 | 7 |
| Number of Participants with Grade 2 TEAE | 2 | 1 | 4 | 1 |
| Number of Participants with Grade 3 or Grade 4 TEAE | 0 | 0 | 0 | 0 |
| Number of Participants with TEAE defined as Serious | 0 | 0 | 0 | 0 |
| Number of participants with TEAE leading to Death | 0 | 0 | 0 | 0 |
| Any TEAEs leading to death | 0 | 0 | 0 | 0 |
| Number of Participants with a TEAE leading to withdrawal from study | 0 | 0 | 0 | 0 |
| Number of Participants with TEAE Related to study drug (possibly, probably and definitely related) | 4 | 2 | 7 | 3 |
| Number of Participants with TEAE considered Unrelated to study drug (unrelated or unlikely related) | 5 | 3 | 4 | 5 |
The Percentage of index subjects demonstrating clinical cure without microscopic or dermatoscopic cure at Day 28, assessed by skin examination to confirm all signs of scabies have completely resolved.
| Participants | Moxidectin 8mg | Moxidectin 16mg | Moxidectin 32mg | Placebo |
|---|---|---|---|---|
| Percentage of Subjects Achieving Day 28 Cure Rates: Clinical Cure | 28 | 31 | 32 | 1 |
The Percentage of index subjects demonstrating microscopic or dermatoscopic cure without clinical cure at Day 28. Microscopic or dermatoscopic cure is assessed by demonstrating the absence of scabies mites, eggs, and/or scybala, and negative dermoscopy for burrows.
| Participants | Moxidectin 8mg | Moxidectin 16mg | Moxidectin 32mg | Placebo |
|---|---|---|---|---|
| Percentage of Subjects Achieving Day 28 Cure Rates: Microscopic or Dermatoscopic Cure Without Clinical Cure. | 40 | 39 | 43 | 5 |
The Percentage of index subjects demonstrating cure as assessed by the Investigator at Day 28.
| Participants | Moxidectin 8mg | Moxidectin 16mg | Moxidectin 32mg | Placebo |
|---|---|---|---|---|
| Scabies infestation is clear with all signs resolved | 31 | 32 | 32 | 1 |
| Scabies infestation is clear with incomplete resolution of signs, no SOC treatment warranted | 10 | 10 | 13 | 3 |
| Scabies infestation is not clear and additional treatment with standard of care is warranted | 9 | 6 | 6 | 44 |
Collected over Day 0 to Week 16, inclusive.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Moxidectin 8mg | 0/50 (0%) | 0/50 (0%) | 9/50 (18%) |
| Moxidectin 16mg | 0/48 (0%) | 0/48 (0%) | 5/48 (10.4%) |
| Moxidectin 32mg | 0/52 (0%) | 0/52 (0%) | 11/52 (21.2%) |
| Placebo | 0/49 (0%) | 0/49 (0%) | 8/49 (16.3%) |
| Event | Moxidectin 8mg | Moxidectin 16mg | Moxidectin 32mg | Placebo |
|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 2/50 | 0/48 | 5/52 | 0/49 |
| HeadacheNervous system disorders | 1/50 | 1/48 | 4/52 | 1/49 |
| InfluenzaInfections and infestations | 3/50 | 1/48 | 1/52 | 1/49 |
| Taste disorderNervous system disorders | 1/50 | 0/48 | 3/52 | 0/49 |
| NauseaGastrointestinal disorders | 0/50 | 1/48 | 2/52 | 1/49 |
| ToothacheGastrointestinal disorders | 0/50 | 1/48 | 0/52 | 0/49 |
| Blood urea decreasedInvestigations | 0/50 | 1/48 | 0/52 | 0/49 |
| Skin burning sensationSkin and subcutaneous tissue disorders | 0/50 | 1/48 | 0/52 | 0/49 |
| PalpitationsCardiac disorders | 0/50 | 1/48 | 0/52 | 0/49 |
| Alanine aminotransferase increasedInvestigations | 1/50 | 0/48 | 1/52 | 1/49 |
A total of 200 index subjects were randomized in the study. 199 (99.5%) randomized index subjects were included in the analysis population (Full Analysis Set and Safety Analysis Set). Only one subject was excluded from these analysis sets as they withdrew prior to IP administration.
| Age, Categorical(Participants) | Moxidectin 8mg | Moxidectin 16mg | Moxidectin 32mg | Placebo | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 47 | 45 | 48 | 45 | 185 |
| >=65 years | 3 | 4 | 3 | 4 | 14 |
| Age, Continuous(Years) | Moxidectin 8mg | Moxidectin 16mg | Moxidectin 32mg | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 38.0 ± 14.80 | 42.6 ± 15.57 | 43.6 ± 14.29 | 42.9 ± 17.90 | 41.8 ± 15.72 |
| Sex: Female, Male(Participants) | Moxidectin 8mg | Moxidectin 16mg | Moxidectin 32mg | Placebo | Total |
|---|---|---|---|---|---|
| Female | 32 | 32 | 33 | 31 | 128 |
| Male | 18 | 17 | 18 | 18 | 71 |
| Ethnicity (NIH/OMB)(Participants) | Moxidectin 8mg | Moxidectin 16mg | Moxidectin 32mg | Placebo | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 49 | 49 | 49 | 45 | 192 |
| Not Hispanic or Latino | 1 | 0 | 2 | 3 | 6 |
| Unknown or Not Reported | 0 | 0 | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Moxidectin 8mg | Moxidectin 16mg | Moxidectin 32mg | Placebo | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 9 | 12 | 17 | 14 | 52 |
| White | 41 | 37 | 34 | 35 | 147 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Moxidectin 8mg | Moxidectin 16mg | Moxidectin 32mg | Placebo | Total |
|---|---|---|---|---|---|
| Dominican Republic | 9 | 11 | 15 | 13 | 48 |
| El Salvador | 18 | 14 | 14 | 15 | 61 |
| Honduras | 16 | 18 | 15 | 15 | 64 |
| United States | 7 | 6 | 7 | 6 | 26 |
| Body Mass Index(Participants) | Moxidectin 8mg | Moxidectin 16mg | Moxidectin 32mg | Placebo | Total |
|---|---|---|---|---|---|
| Underweight (<18.5) | 0 | 1 | 0 | 0 | 1 |
| Healthy weight (≥ 18.5 to < 25) | 14 | 14 | 18 | 15 | 61 |
| Overweight (≥25 to < 30) | 26 | 22 | 19 | 22 | 89 |
| Obese (≥ 30) | 10 | 12 | 14 | 12 | 48 |
| Baseline Scabies Disease Characteristics - Scabies Severity(Participants) | Moxidectin 8mg | Moxidectin 16mg | Moxidectin 32mg | Placebo | Total |
|---|---|---|---|---|---|
| Mild (≤ 10 lesions) | 3 | 4 | 4 | 4 | 15 |
| Moderate (≥ 11 and ≤ 49 lesions) | 34 | 35 | 42 | 34 | 145 |
| Severe (≥ 50 lesions) | 13 | 10 | 5 | 11 | 39 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Deidentified individual participant data in the form of data listings and datasets may be available for sharing on application to the Sponsor.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will become available 12 months after publication, ending 36 months following publication.
Access criteria: Provision of a methodologically sound and relevant proposal detailing the intended use of the data and relevant ethics approval for the proposed analysis, as applicable.
Ran from Nov 2023 to primary completion in Nov 2024, 12 months.
Results were first posted in Jun 2026, 1 year 6 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Moxidectin
Medicines Development for Global Health