Efficacy and Safety Study of Moxidectin in Adults With Scabies

NCT05875441 | Completed Phase 2 FDA Drug

• 1 other identifier: MDGH-MOX-2002
• Study Type: interventional
• Target: 200
• Locations: 4 countries
• Sites: 9

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.

Conditions

Scabies

Keywords

Moxidectin; Oral

Outcome Measures

Primary Outcomes (2)

• Proportion of index subjects achieving complete cure (Efficacy)

  Proportion of index subjects achieving Complete Cure at Day 28. 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)

  Incidence and severity of Treatment Emergent Adverse Event (TEAEs), Incidence of serious TEAEs and Incidence of TEAEs leading to study withdrawal and/or death.

  84 Days

Other Outcomes (2)

• Proportion of index subjects achieving clinical cure without microscopic or dermatoscopic cure, assessed by skin examination to confirm all signs of scabies have completely resolved.

  28 Days

• Proportion of index subjects achieving microscopic or dermatoscopic cure without clinical cure. Microscopic or dermatoscopic cure is assessed by demonstrating the absence of scabies mites, eggs, and/or scybala, and negative dermoscopy for burrows.

  28 Days

Study Arms (4)

Moxidectin 8mg

EXPERIMENTAL

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

Moxidectin 16mg

EXPERIMENTAL

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

Moxidectin 32mg

EXPERIMENTAL

Moxidectin 32 mg (over encapsulated) will be administered as a single dose on Day 0.

Drug: Moxidectin Oral Product

Placebo

PLACEBO COMPARATOR

16 Placebo capsules will be administered as a single dose on Day 0.

Drug: Placebo

Interventions

Moxidectin Oral Product DRUG

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 8mg

Placebo DRUG

16 placebo capsules will be administered as a single dose.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older.
• Provided written informed consent.
• 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.
• 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).

You may not qualify if:

• 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).
• 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.
• 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.
• Body mass index \> 35 kg/m2.
• Creatinine clearance \< 30 mL/min (using Cockcroft-Gault equation).
• Both total bilirubin \>1.5 x upper limit of normal (ULN) and AST \> ULN.
• 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.
• 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.
• 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.
• 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.
• Received an investigational agent within 28 days of Screening (or 5 half-lives of the investigational agent, whichever is longer).
• Known or suspected hypersensitivity to macrocyclic lactones or excipients used in the formulation of moxidectin or ivermectin.
• 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.
• Known, suspected or at risk of Loa loa coinfection.
• Difficulty swallowing tablets or capsules.

Sponsors & Collaborators

• Medicines Development for Global Health: lead

Study Sites (9)

LA Universal Research Center, Inc

Los Angeles, California, 90057, United States

Location

Evolution Clinical Trials

Miami, Florida, 33016, United States

Location

Advanced Care and Clinical Trials, LLC

Miami, Florida, 33155, United States

Location

Medical Research of Westchester, Inc

Miami, Florida, 33165, United States

Location

Affinity Clinical Research LLC

Tampa, Florida, 33612, United States

Location

Instituto Dermatologico Dominicano y Cirugia de Piel

Santo Domingo Oeste, Santo Domingo Province, Dominican Republic

Location

Vargas Clinic

San Salvador, San Salvador Department, 01101, El Salvador

Location

Derclinic

San Pedro Sula, Cortez, 21104, Honduras

Location

Hospital y Clinica Bendana

San Pedro Sula, Cortés Department, 21104, Honduras

Location

MeSH Terms

Conditions

Scabies

Condition Hierarchy (Ancestors)

Mite Infestations; Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinded. Subjects will be randomized to one of the treatment arm by Interactive Response Technology at 1:1:1:1
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 25, 2023
• Study Start: November 23, 2023
• Primary Completion: November 27, 2024
• Study Completion: February 11, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-05

Locations

DO (1); US (5); HO (2); EL (1)