NCT05875441

Efficacy and Safety Study of Moxidectin in Adults With Scabies

A Phase 2, Placebo-controlled, Double-blind, Randomized, Dose Ranging, Efficacy and Safety Study of Orally Administered Moxidectin in Adults With Scabies.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Medicines Development for Global Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-11-23
• Primary completion: 2024-11-27
• Completion: 2025-02-11
• First posted: 2023-05-25
• Last updated: 2025-05-04

Locations

9 sites across 4 countries: United States, Dominican Republic, El Salvador, Honduras

Regulatory

• FDA-regulated drug study