Efficacy and Safety Study of Moxidectin in Adults With Scabies

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

Interventions

DRUG

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

DRUG

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

DRUG

Moxidectin Oral Product

The required number of moxidectin 2 mg tablet over encapsulated capsules will be administered as a single dose.

DRUG

Placebo

16 placebo capsules will be administered as a single dose.

Sponsors & Collaborators

• Medicines Development for Global Health

  lead OTHER

Principal Investigators

• Richard L Fernandez, MD · Advance Care and Clinical Trials

• Jorge Lopez, MD · Hospital y Clinica Bendana

• Daisy Blanco, MD · Instituto Dermatologico Dominicano y Cirugia de Pie

• Jorge Castillo Molina, MD · Affinity Clinical Research Services

• Patricia A Zuniga Munoz, MD · Derclinic

• Laura B Vargas Rivas, MD · Vargas Clinic

• Gilberto Perez, MD · Evolution Clinical Trials

• Armando Pineda-Velez, MD · Medical Research of Westchester, Inc

• Bruce Torkan, MD · LA Universal Research Center, Inc

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-23

Primary Completion

2024-11-27

Completion

2025-02-11

FDA Drug

Yes

Countries

• United States
• Dominican Republic
• El Salvador
• Honduras

Study Locations