Efficacy and Safety Study of Moxidectin in Adults With Scabies

June 14, 2026 updated by: Medicines Development for Global Health

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Dominican Republic
    • Santo Domingo Province
      • Santo Domingo Oeste, Santo Domingo Province, Dominican Republic
        • Instituto Dermatologico Dominicano y Cirugia de Piel
  • El Salvador
    • San Salvador Department
      • San Salvador, San Salvador Department, El Salvador, 01101
        • Vargas Clinic
  • Honduras
    • Cortez
      • San Pedro Sula, Cortez, Honduras, 21104
        • Derclinic
    • Cortés Department
      • San Pedro Sula, Cortés Department, Honduras, 21104
        • Hospital y Clinica Bendana
  • United States
    • California
      • Los Angeles, California, United States, 90057
        • La Universal Research Center, Inc
    • Florida
      • Miami, Florida, United States, 33155
        • Advanced Care and Clinical Trials, LLC
      • Miami, Florida, United States, 33016
        • Evolution Clinical Trials
      • Miami, Florida, United States, 33165
        • Medical Research of Westchester, Inc
      • Tampa, Florida, United States, 33612
        • Affinity Clinical Research LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 18 years or older.
  2. Provided written informed consent.
  3. 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.
  4. 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).

Exclusion Criteria:

  1. 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).
  2. 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.
  3. 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.
  4. Body mass index > 35 kg/m2.
  5. Creatinine clearance < 30 mL/min (using Cockcroft-Gault equation).
  6. Both total bilirubin >1.5 x upper limit of normal (ULN) and AST > ULN.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. Received an investigational agent within 28 days of Screening (or 5 half-lives of the investigational agent, whichever is longer).
  12. Known or suspected hypersensitivity to macrocyclic lactones or excipients used in the formulation of moxidectin or ivermectin.
  13. 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.
  14. Known, suspected or at risk of Loa loa coinfection.
  15. Difficulty swallowing tablets or capsules.
  16. Pregnant or breastfeeding or planning to become pregnant from Screening until 16 weeks after treatment with IP.
  17. Known or suspected alcohol or illicit substance abuse.
  18. Unwilling, unlikely or unable to comply with all protocol specified assessments.
  19. Previous enrolment in this study.
  20. Previous moxidectin exposure within 6 months (5 half-lives) from Baseline.
  21. Has household members who refuse or are unable to receive permethrin 5% cream treatment for scabies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Moxidectin 8mg
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
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
Drug: Moxidectin Oral Product
The required number of moxidectin 2 mg tablet over encapsulated capsules will be administered as a single dose.
Experimental: Moxidectin 16mg
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
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
Drug: Moxidectin Oral Product
The required number of moxidectin 2 mg tablet over encapsulated capsules will be administered as a single dose.
Experimental: Moxidectin 32mg
Moxidectin 32 mg (over encapsulated) will be administered as a single dose on Day 0.
Drug: Moxidectin Oral Product
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
Drug: Moxidectin Oral Product
The required number of moxidectin 2 mg tablet over encapsulated capsules will be administered as a single dose.
Placebo Comparator: Placebo
16 Placebo capsules will be administered as a single dose on Day 0.
Drug: Placebo
16 placebo capsules will be administered as a single dose.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
28 Days
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.
Day 0 to Week 16 inclusive.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Achieving Day 28 Cure Rates: Clinical Cure
Time Frame: 28 Days
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.
28 Days
Percentage of Subjects Achieving Day 28 Cure Rates: Microscopic or Dermatoscopic Cure Without Clinical Cure.
Time Frame: 28 Days
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.
28 Days
Percentage of Subjects Reporting Day 28 Cure Rates: Investigator Assessed Cure
Time Frame: Day 28
The Percentage of index subjects demonstrating cure as assessed by the Investigator at Day 28.
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medicines Development for Global Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard L Fernandez, MD, Advance Care and Clinical Trials
  • Principal Investigator: Jorge Lopez, MD, Hospital y Clinica Bendana
  • Principal Investigator: Daisy Blanco, MD, Instituto Dermatologico Dominicano y Cirugia de Pie
  • Principal Investigator: Jorge Castillo Molina, MD, Affinity Clinical Research Services
  • Principal Investigator: Patricia A Zuniga Munoz, MD, Derclinic
  • Principal Investigator: Laura B Vargas Rivas, MD, Vargas Clinic
  • Principal Investigator: Gilberto Perez, MD, Evolution Clinical Trials
  • Principal Investigator: Armando Pineda-Velez, MD, Medical Research of Westchester, Inc
  • Principal Investigator: Bruce Torkan, MD, La Universal Research Center, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 23, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 27, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 11, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MDGH-MOX-2002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual participant data in the form of data listings and datasets may be available for sharing on application to the Sponsor.

IPD Sharing Time Frame

Data will become available 12 months after publication, ending 36 months following publication.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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