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Could a single pill cure scabies? new study tests three doses
NCT ID NCT05875441
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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200 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Feb 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Advanced Care and Clinical Trials, LLC
Miami, Florida, 33155, United States
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Affinity Clinical Research LLC
Tampa, Florida, 33612, United States
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Derclinic
San Pedro Sula, Cortez, 21104, Honduras
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Evolution Clinical Trials
Miami, Florida, 33016, United States
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Hospital y Clinica Bendana
San Pedro Sula, Cortés Department, 21104, Honduras
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Instituto Dermatologico Dominicano y Cirugia de Piel
Santo Domingo Oeste, Santo Domingo Province, Dominican Republic
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LA Universal Research Center, Inc
Los Angeles, California, 90057, United States
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Medical Research of Westchester, Inc
Miami, Florida, 33165, United States
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Vargas Clinic
San Salvador, San Salvador Department, 01101, El Salvador
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