Efficacy and Safety Study of Moxidectin in Adults With Scabies
NCT ID: NCT05875441
Last Updated: 2025-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
200 participants
INTERVENTIONAL
2023-11-23
2025-02-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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
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.
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
Moxidectin 32mg
Moxidectin 32 mg (over encapsulated) will be administered as a single dose on Day 0.
Moxidectin Oral Product
The required number of moxidectin 2 mg tablet over encapsulated capsules will be administered as a single dose.
Placebo
16 Placebo capsules will be administered as a single dose on Day 0.
Placebo
16 placebo capsules will be administered as a single dose.
Interventions
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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
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
Moxidectin Oral Product
The required number of moxidectin 2 mg tablet over encapsulated capsules will be administered as a single dose.
Placebo
16 placebo capsules will be administered as a single dose.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Medicines Development for Global Health
OTHER
Responsible Party
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Principal Investigators
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Richard L Fernandez, MD
Role: PRINCIPAL_INVESTIGATOR
Advance Care and Clinical Trials
Jorge Lopez, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital y Clinica Bendana
Daisy Blanco, MD
Role: PRINCIPAL_INVESTIGATOR
Instituto Dermatologico Dominicano y Cirugia de Pie
Jorge Castillo Molina, MD
Role: PRINCIPAL_INVESTIGATOR
Affinity Clinical Research Services
Patricia A Zuniga Munoz, MD
Role: PRINCIPAL_INVESTIGATOR
Derclinic
Laura B Vargas Rivas, MD
Role: PRINCIPAL_INVESTIGATOR
Vargas Clinic
Gilberto Perez, MD
Role: PRINCIPAL_INVESTIGATOR
Evolution Clinical Trials
Armando Pineda-Velez, MD
Role: PRINCIPAL_INVESTIGATOR
Medical Research of Westchester, Inc
Bruce Torkan, MD
Role: PRINCIPAL_INVESTIGATOR
LA Universal Research Center, Inc
Locations
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LA Universal Research Center, Inc
Los Angeles, California, United States
Evolution Clinical Trials
Miami, Florida, United States
Advanced Care and Clinical Trials, LLC
Miami, Florida, United States
Medical Research of Westchester, Inc
Miami, Florida, United States
Affinity Clinical Research LLC
Tampa, Florida, United States
Instituto Dermatologico Dominicano y Cirugia de Piel
Santo Domingo Oeste, Santo Domingo Province, Dominican Republic
Vargas Clinic
San Salvador, San Salvador Department, El Salvador
Derclinic
San Pedro Sula, Cortez, Honduras
Hospital y Clinica Bendana
San Pedro Sula, Cortés Department, Honduras
Countries
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Other Identifiers
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MDGH-MOX-2002
Identifier Type: -
Identifier Source: org_study_id
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