Moxidectin for Scabies

Recruiting at 10 trial locations

Overseen By Vidya Uprety

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Medicines Development for Global Health

Must not be taking: Scabicides, Topical steroids, BCRP inhibitors

Disqualifiers: Crusted scabies, BMI > 35, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 on the Research Team?

Richard Fernandez, MD

Principal Investigator

Advance Care and Clinical Trials

Jorge Lopez, MD

Principal Investigator

Hospital y Clinica Bendana

Daisy Blanco, MD

Principal Investigator

Instituto Dermatologico Dominicano y Cirugia de Pie

Jorge Castillo Molina, MD

Principal Investigator

Affinity Clinical Research Services

Patricia A Zuniga Munoz, MD

Principal Investigator

Derclinic

Laura B Vargas Rivas, MD

Principal Investigator

Vargas Clinic

Gilberto Perez, MD

Principal Investigator

Evolution Clinical Trials

Armando Pineda-Velez, MD

Principal Investigator

Medical Research of Westchester, Inc

Bruce Torkan, MD

Principal Investigator

LA Universal Research Center, Inc

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Provided written informed consent

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)

I have been diagnosed with scabies confirmed by skin tests.

Exclusion Criteria

You have a known, suspected, or at risk of having a Loa loa infection.

I have trouble swallowing pills.

I haven't taken moxidectin in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of moxidectin (8 mg, 16 mg, or 32 mg) or placebo on Day 0

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

84 days

Multiple visits (in-person and/or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Moxidectin

Trial Overview 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.

How Is the Trial Designed?

Group I: Moxidectin 8mg Experimental Treatment 1 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 32mg Experimental Treatment 1 Intervention

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

Group III: Moxidectin 16mg Experimental Treatment 1 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: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Medicines Development for Global Health

Lead Sponsor

Trials

9

Recruited

15,300+