ScabiesPhase 2NCT05875441

Efficacy and Safety Study of Moxidectin in Adults With Scabies

A Phase 2 study testing Moxidectin Oral Product in people with Scabies, run by Medicines Development for Global Health at 9 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Scabies
What is being tested?: Moxidectin Oral Product
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 200 participants
Where: 9 sitesin 4 countries
Study dates: 23 Nov 2023to 11 Feb 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Aged 18 years or older.
Provided written informed consent.
Diagnosis of active scabies infestation confirmed by the presence of clinical signs and symptoms (evidence of burrows or typical inflammatory/noninflammatory lesions and pruritus) and either microscopic confirmation of scabies mite(s), ova or scybala by skin scraping or dermoscopy.
All female subjects of childbearing potential must agree to the use of a highly effective method of birth control until 16 weeks after administration of Investigational Product (IP).

Who cannot join

Diagnosis of crusted/Norwegian scabies or scabies presentation that, in the opinion of the Investigator, would require treatment with more than one standard of care treatment for scabies (e.g., scabies requiring concurrent topical and oral treatment).
History of chronic or recurrent dermatologic disease or skin conditions other than scabies that could interfere with the diagnosis of scabies and evaluation of cure.
Received any treatment with one or more scabicides within the 28 days prior to Screening, or between Screening and Baseline, including but not limited to permethrin, ivermectin, benzyl benzoate, sulfur, lindane, crotamiton, malathion, tea tree oil or spinosad.
Body mass index > 35 kg/m2.
Creatinine clearance < 30 mL/min (using Cockcroft-Gault equation).
Both total bilirubin >1.5 x upper limit of normal (ULN) and AST > ULN.

Show all 21Show fewer

Abnormal and clinically relevant findings in hematology or biochemistry assessments at Screening, or in vital signs, 12-lead ECG, or physical examination at Screening and/or Baseline, that in the opinion of the Investigator would put the subjects at increased risk from participating in the study, confound study evaluations, or may interfere with study conduct.
Presence of any other clinically relevant condition, including infection, immunological disorder, malignant disease, and/or other underlying condition or circumstance at Screening or Baseline that in the opinion of the Investigator would put the subjects at increased risk from participating in the study, confound study evaluations, or interfere with the study conduct.
Use of topical steroids, systemic or high-dose inhaled corticosteroids (>500 µg per day of fluticasone propionate or equivalent for adults), or other immunomodulators within 14 days of Baseline.
Requiring ongoing treatment with, or received within 5 half-lives before Screening, any of the following medications that are clinical BCRP inhibitors: curcurmin (turmeric) supplements, cyclosporine A, darolutamide, eltrombopag, febuxostat, fostamatinib, rolapitant and teriflunomide.
Received an investigational agent within 28 days of Screening (or 5 half-lives of the investigational agent, whichever is longer).
Known or suspected hypersensitivity to macrocyclic lactones or excipients used in the formulation of moxidectin or ivermectin.
Known or suspected hypersensitivity to any of the components in permethrin 5% cream, to any synthetic pyrethroid or pyrethrin, or to the components of spinosad 0.9% topical suspension.
Known, suspected or at risk of Loa loa coinfection.
Difficulty swallowing tablets or capsules.
Pregnant or breastfeeding or planning to become pregnant from Screening until 16 weeks after treatment with IP.
Known or suspected alcohol or illicit substance abuse.
Unwilling, unlikely or unable to comply with all protocol specified assessments.
Previous enrolment in this study.
Previous moxidectin exposure within 6 months (5 half-lives) from Baseline.
Has household members who refuse or are unable to receive permethrin 5% cream treatment for scabies.

Trial locations and contacts

9 sites in 4 countries.

Country

City, postcode or hospital

9 sites in 4 countries

United States5 sites

LA Universal Research Center, Inc
Los Angeles, California, 90057
Evolution Clinical Trials
Miami, Florida, 33016
Advanced Care and Clinical Trials, LLC
Miami, Florida, 33155
Medical Research of Westchester, Inc
Miami, Florida, 33165
Affinity Clinical Research LLC
Tampa, Florida, 33612

Other trials in United States

Honduras2 sites

Derclinic
San Pedro Sula, Cortez, 21104
Hospital y Clinica Bendana
San Pedro Sula, Cortés Department, 21104

Other trials in Honduras

Dominican Republic1 site

Instituto Dermatologico Dominicano y Cirugia de Piel
Santo Domingo Oeste, Santo Domingo Province

Other trials in Dominican Republic

El Salvador1 site

Vargas Clinic
San Salvador, San Salvador Department, 01101

Other trials in El Salvador

About this study

Official title: A Phase 2, Placebo-controlled, Double-blind, Randomized, Dose Ranging, Efficacy and Safety Study of Orally Administered Moxidectin in Adults With Scabies.

Conditions: Scabies
Being tested: Moxidectin Oral Product, Placebo
Keywords: Moxidectin, Oral
Medical subject headings: Scabies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Moxidectin Oral ProductDrug
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
Moxidectin Oral ProductDrug
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
Moxidectin Oral ProductDrug
The required number of moxidectin 2 mg tablet over encapsulated capsules will be administered as a single dose.
PlaceboDrug
16 placebo capsules will be administered as a single dose.

Study groups in NCT05875441
Study group	Role	What they receive
Moxidectin 8mg	Experimental	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. Receives: Drug: Moxidectin Oral Product
Moxidectin 16mg	Experimental	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. Receives: Drug: Moxidectin Oral Product
Moxidectin 32mg	Experimental	Moxidectin 32 mg (over encapsulated) will be administered as a single dose on Day 0. Receives: Drug: Moxidectin Oral Product
Placebo	Placebo comparator	16 Placebo capsules will be administered as a single dose on Day 0. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Day 0 to Week 16 inclusive.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Nov 202311 Feb 2025

First posted25 May 2023
Study start23 Nov 2023
Primary completion27 Nov 2024
Study completion11 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ScabiesStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Placebo-controlled, double-blind, randomized, dose ranging study. Four cohorts of 50 subjects per cohort are planned. Subjects will be randomized 1:1:1:1 to receive Moxidectin 8mg, Moxidectin 16mg, Moxidectin 32mg or Placebo as a single oral dose.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05875441
Sponsor's protocol ID: MDGH-MOX-2002
Status last verified: May 2025
First submitted: 16 May 2023
Last updated: 16 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Deidentified individual participant data in the form of data listings and datasets may be available for sharing on application to the Sponsor.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Scabies trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Placebo-controlled, Double-blind, Randomized, Dose Ranging, Efficacy and Safety Study of Orally Administered Moxidectin in Adults With Scabies.
ClinicalTrials.gov ID: NCT05875441
Acronym / sponsor ID: MDGH-MOX-2002
Conditions: Scabies
Keywords: Moxidectin, Oral
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Medicines Development for Global HealthUniversity, hospital or other
Study start: 23 Nov 2023 (actual)
Primary completion: 27 Nov 2024 (actual)
Study completion: 11 Feb 2025 (actual)
First posted: 25 May 2023 (actual)
Results: Posted 16 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: Placebo-controlled, double-blind, randomized, dose ranging study. Four cohorts of 50 subjects per cohort are planned. Subjects will be randomized 1:1:1:1 to receive Moxidectin 8mg, Moxidectin 16mg, Moxidectin 32mg or Placebo as a single oral dose.

Arm	Type	Receives
Moxidectin 8mg	Experimental	Drug: Moxidectin Oral ProductMoxidectin 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.
Moxidectin 16mg	Experimental	Drug: Moxidectin Oral ProductMoxidectin 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.
Moxidectin 32mg	Experimental	Drug: Moxidectin Oral ProductMoxidectin 32 mg (over encapsulated) will be administered as a single dose on Day 0.
Placebo	Placebo comparator	Drug: Placebo16 Placebo capsules will be administered as a single dose on Day 0.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Aged 18 years or older.
Provided written informed consent.
Diagnosis of active scabies infestation confirmed by the presence of clinical signs and symptoms (evidence of burrows or typical inflammatory/noninflammatory lesions and pruritus) and either microscopic confirmation of scabies mite(s), ova or scybala by skin scraping or dermoscopy.
All female subjects of childbearing potential must agree to the use of a highly effective method of birth control until 16 weeks after administration of Investigational Product (IP).

Key exclusion criteria (21 listed)

Diagnosis of crusted/Norwegian scabies or scabies presentation that, in the opinion of the Investigator, would require treatment with more than one standard of care treatment for scabies (e.g., scabies requiring concurrent topical and oral treatment).
History of chronic or recurrent dermatologic disease or skin conditions other than scabies that could interfere with the diagnosis of scabies and evaluation of cure.
Received any treatment with one or more scabicides within the 28 days prior to Screening, or between Screening and Baseline, including but not limited to permethrin, ivermectin, benzyl benzoate, sulfur, lindane, crotamiton, malathion, tea tree oil or spinosad.
Body mass index > 35 kg/m2.
Creatinine clearance < 30 mL/min (using Cockcroft-Gault equation).

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
Moxidectin Oral ProductThe required number of moxidectin 2 mg tablet over encapsulated capsules will be administered as a single dose with placebo capsules to match as required	Drug	Moxidectin 8mg
Moxidectin Oral ProductThe required number of moxidectin 2 mg tablet over encapsulated capsules will be administered as a single dose with placebo capsules to match as required	Drug	Moxidectin 16mg
Moxidectin Oral ProductThe required number of moxidectin 2 mg tablet over encapsulated capsules will be administered as a single dose.	Drug	Moxidectin 32mg
Placebo16 placebo capsules will be administered as a single dose.	Drug	Placebo

Primary outcome

Percentage of Index Subjects Achieving Complete Cure (Efficacy)
Time frame: 28 Days
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.
Incidence and Severity of Treatment Emergent Adverse Event (Safety)
Time frame: Day 0 to Week 16 inclusive.
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.

Results and safety

Results posted to the registry on 16 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Moxidectin 8mg	50	50
Moxidectin 16mg	50	48
Moxidectin 32mg	51	50
Placebo	49	48

Primary outcome: Percentage of Index Subjects Achieving Complete Cure (Efficacy)

Time frame: 28 Days. Count of participants. Unit: Participants

Measure	Moxidectin 8mg n = 50	Moxidectin 16mg n = 49	Moxidectin 32mg n = 51	Placebo n = 49
Value	28	31	32	1

Population analysed: The Full Analysis Set defined as all randomized index subjects receiving study drug and analyzed according to the treatment group to which they were randomized.

Primary outcome: Incidence and Severity of Treatment Emergent Adverse Event (Safety)

Time frame: Day 0 to Week 16 inclusive.. Number. Unit: participants

Measure	Moxidectin 8mg n = 50	Moxidectin 16mg n = 48	Moxidectin 32mg n = 52	Placebo n = 49
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

Population analysed: Safety was analyzed using the Safety Analysis Set (SfAS) defined as all index subjects exposed to IP. For the SfAS, subjects were analyzed as per the actual treatment received regardless of their randomized group. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for SfAS. Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.

Adverse events

Time frame: Day 0 to Week 16, inclusive.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Moxidectin 8mg	0 of 50 (0%)	9 of 50 (18%)	0 of 50
Moxidectin 16mg	0 of 48 (0%)	5 of 48 (10.4%)	0 of 48
Moxidectin 32mg	0 of 52 (0%)	11 of 52 (21.2%)	0 of 52
Placebo	0 of 49 (0%)	8 of 49 (16.3%)	0 of 49

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Deidentified individual participant data in the form of data listings and datasets may be available for sharing on application to the Sponsor.

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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.

Richard L Fernandez, MD principal investigator

Advance Care and Clinical Trials

Jorge Lopez, MD principal investigator

Hospital y Clinica Bendana

Daisy Blanco, MD principal investigator

Instituto Dermatologico Dominicano y Cirugia de Pie

9 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Moxidectin Oral Product in people with Scabies, run by Medicines Development for Global Health at 9 sites in 4 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 4 inclusion and 21 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 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, Honduras, Dominican Republic, El Salvador. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Index Subjects Achieving Complete Cure (Efficacy) (time frame: 28 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 NCT05875441.

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 16 Jun 2026.