200 Participants Needed

Moxidectin for Scabies

Recruiting at 10 trial locations
VU
Overseen ByVidya Uprety
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Medicines Development for Global Health
Prior Safety DataThis treatment has passed at least one previous human trial

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?

RL

Richard Fernandez, MD

Principal Investigator

Advance Care and Clinical Trials

JL

Jorge Lopez, MD

Principal Investigator

Hospital y Clinica Bendana

DB

Daisy Blanco, MD

Principal Investigator

Instituto Dermatologico Dominicano y Cirugia de Pie

JC

Jorge Castillo Molina, MD

Principal Investigator

Affinity Clinical Research Services

PA

Patricia A Zuniga Munoz, MD

Principal Investigator

Derclinic

LB

Laura B Vargas Rivas, MD

Principal Investigator

Vargas Clinic

GP

Gilberto Perez, MD

Principal Investigator

Evolution Clinical Trials

AP

Armando Pineda-Velez, MD

Principal Investigator

Medical Research of Westchester, Inc

BT

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.
See 7 more

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?
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Moxidectin 8mgExperimental Treatment1 Intervention
Group II: Moxidectin 32mgExperimental Treatment1 Intervention
Group III: Moxidectin 16mgExperimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medicines Development for Global Health

Lead Sponsor

Trials
9
Recruited
15,300+
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