What side effects are associated with this type of intervention?

Common treatments for scabies, such as ivermectin and permethrin, have known side effects. Ivermectin can cause side effects like headache, dizziness, muscle pain, nausea, and diarrhea. In rare cases, it may lead to more severe reactions such as hypotension and liver damage. Permethrin, a topical treatment, may cause skin irritation, redness, and itching at the application site. Both treatments are generally well-tolerated, but patients should be monitored for adverse reactions.

What prior FDA approvals exist?

The FDA has approved several antiparasitic agents for the treatment of scabies. The most commonly used treatments include permethrin cream 5%, which is a topical scabicide, and oral ivermectin, which is used off-label but has shown efficacy in treating scabies. These treatments target the scabies mites effectively. Moxidectin, another antiparasitic agent, is currently being studied for its efficacy in treating scabies, but it has not yet received FDA approval for this indication.

What other types of research exist?

Promising alternatives to Moxidectin for treating scabies include Ivermectin, which is an oral antiparasitic agent commonly used for scabies, and Permethrin, a topical treatment. Both have demonstrated efficacy and safety in treating scabies. Additionally, ongoing research may introduce new treatments, so it is advisable to consult with a healthcare provider for the latest options.

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Anti-parasitic

Moxidectin for Scabies

Phase 2

Recruiting

Led By Oscar De Valle, MD

Research Sponsored by Medicines Development for Global Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18 years or older

Provided written informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 84 days

Summary

This trial is testing moxidectin, a medication, to see if it can cure scabies in adults. The study will evaluate different doses to find out which one is most effective and safe. Moxidectin works by killing the mites that cause scabies. Moxidectin is being considered for development as a treatment for human scabies.

Who is the study for?

Adults over 18 with active scabies, confirmed by clinical signs and microscopic evidence, can join this trial. Women who can have children must use effective birth control until 16 weeks after the study drug is taken. People cannot participate if they've had moxidectin recently, have trouble swallowing pills, are allergic to certain meds, abuse substances, live with untreated scabies cases or need other immune treatments.

What is being tested?

The trial tests how well a single dose of Moxidectin (8 mg, 16 mg or 32 mg) works in curing scabies by Day 28 compared to a placebo. It's also looking at the safety of these doses for adults with scabies.

What are the potential side effects?

Potential side effects from Moxidectin may include allergic reactions for those sensitive to similar medications; however specific side effects related to treating scabies are not detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with scabies confirmed by skin tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 84 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~84 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 84 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence and severity of Treatment Emergent Adverse Event (Safety)

Proportion of index subjects achieving complete cure (Efficacy)

Other study objectives

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.

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.

Side effects data

From 2022 Phase 2 trial • 22 Patients • NCT03905265

75%

Acarodermatitis

50%

Eczema

25%

Nausea

25%

Diarrhoea

25%

Toothache

100%

80%

60%

40%

20%

Study treatment Arm

Moxidectin 8 mg

Moxidectin 36 mg

Moxidectin 2 mg

Moxidectin 20 mg

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Moxidectin 8mgExperimental Treatment1 Intervention

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.

Group II: Moxidectin 32mgExperimental Treatment1 Intervention

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

Group III: Moxidectin 16mgExperimental Treatment1 Intervention

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.

Group IV: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Moxidectin Oral Product

2020

Completed Phase 2

~30

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for scabies, such as moxidectin, ivermectin, and permethrin, work by targeting the nervous system of the scabies mites, leading to paralysis and death of the parasites. Moxidectin, for example, binds to glutamate-gated chloride channels in the mites, increasing the permeability of the cell membrane to chloride ions, which results in hyperpolarization and paralysis. This mechanism is crucial for scabies patients as it directly eliminates the mites responsible for the infestation, thereby reducing symptoms like intense itching and preventing the spread of the condition to others.