Scabies
Conditions
Keywords
Moxidectin, Oral
Brief 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. This study also aims to assess the safety of three strengths of single moxidectin doses in adults with scabies.
Interventions
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
DRUGPlacebo
16 placebo capsules will be administered as a single dose.
Sponsors
Medicines Development for Global Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blinded. Subjects will be randomized to one of the treatment arm by Interactive Response Technology at 1:1:1:1
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Index Subjects Achieving Complete Cure (Efficacy) | 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) | 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. |
Countries
Dominican Republic, El Salvador, Honduras, United States
Contacts
PRINCIPAL_INVESTIGATORRichard L Fernandez, MD
Advance Care and Clinical Trials
PRINCIPAL_INVESTIGATORJorge Lopez, MD
Hospital y Clinica Bendana
PRINCIPAL_INVESTIGATORDaisy Blanco, MD
Instituto Dermatologico Dominicano y Cirugia de Pie
PRINCIPAL_INVESTIGATORJorge Castillo Molina, MD
Affinity Clinical Research Services
PRINCIPAL_INVESTIGATORPatricia A Zuniga Munoz, MD
Derclinic
PRINCIPAL_INVESTIGATORLaura B Vargas Rivas, MD
Vargas Clinic
PRINCIPAL_INVESTIGATORGilberto Perez, MD
Evolution Clinical Trials
PRINCIPAL_INVESTIGATORArmando Pineda-Velez, MD
Medical Research of Westchester, Inc
PRINCIPAL_INVESTIGATORBruce Torkan, MD
LA Universal Research Center, Inc
Participant flow
Recruitment details
The study was open to recruitment on 9 Nov 2023 and the first participant was screened on 14 Nov 2023. Last participant last study visit was completed on 11 Feb 2025.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 185 Participants |
| Age, Continuous | 41.8 Years STANDARD_DEVIATION 15.72 |
| Baseline Scabies Disease Characteristics: Mean Number of lesions | 29.8 Number of lesions STANDARD_DEVIATION 19 |
| Baseline Scabies Disease Characteristics Number body regions affected | 3.7 Number body regions affected STANDARD_DEVIATION 1.71 |
| Baseline Scabies Disease Characteristics - Scabies Severity Mild (≤ 10 lesions) | 3 Participants |
| Baseline Scabies Disease Characteristics - Scabies Severity Moderate (≥ 11 and ≤ 49 lesions) | 145 Participants |
| Baseline Scabies Disease Characteristics - Scabies Severity Severe (≥ 50 lesions) | 39 Participants |
| Body Mass Index Healthy weight (≥ 18.5 to < 25) | 61 Participants |
| Body Mass Index Obese (≥ 30) | 12 Participants |
| Body Mass Index Overweight (≥25 to < 30) | 89 Participants |
| Body Mass Index Underweight (<18.5) | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 192 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 147 Participants |
| Region of Enrollment Dominican Republic | 48 participants |
| Region of Enrollment El Salvador | 61 participants |
| Region of Enrollment Honduras | 18 participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 48 | 0 / 52 | 0 / 49 |
| other Total, other adverse events | 9 / 50 | 5 / 48 | 11 / 52 | 8 / 49 |
| serious Total, serious adverse events | 0 / 50 | 0 / 48 | 0 / 52 | 0 / 49 |
Outcome results
None listed