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Could a single pill cure scabies? new study tests three doses

NCT ID NCT05875441

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a single dose of an oral drug called moxidectin can cure scabies, a skin condition caused by tiny mites. 200 adults with confirmed scabies received either 8 mg, 16 mg, or 32 mg of moxidectin or a placebo. The main goal was to see if the drug could completely clear the infection by day 28, and to check for side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

200 people

The number who actually took part.

Started

Nov 2023

Finished

Feb 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Advanced Care and Clinical Trials, LLC

    Miami, Florida, 33155, United States

  • Affinity Clinical Research LLC

    Tampa, Florida, 33612, United States

  • Derclinic

    San Pedro Sula, Cortez, 21104, Honduras

  • Evolution Clinical Trials

    Miami, Florida, 33016, United States

  • Hospital y Clinica Bendana

    San Pedro Sula, Cortés Department, 21104, Honduras

  • Instituto Dermatologico Dominicano y Cirugia de Piel

    Santo Domingo Oeste, Santo Domingo Province, Dominican Republic

  • LA Universal Research Center, Inc

    Los Angeles, California, 90057, United States

  • Medical Research of Westchester, Inc

    Miami, Florida, 33165, United States

  • Vargas Clinic

    San Salvador, San Salvador Department, 01101, El Salvador

More trials for these conditions

Other studies related to the condition(s) this trial covers.