Moxidectin for Scabies

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different doses of moxidectin, a potential new treatment for scabies, to evaluate its effectiveness and safety. Participants will receive either a placebo (a pill with no active drug) or one of three doses of moxidectin (8 mg, 16 mg, or 32 mg) to determine the most effective dose for curing scabies by Day 28. Eligible participants should have an active scabies infection with symptoms such as itching and visible burrows or skin lesions. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to the development of a new scabies treatment.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop using any scabies treatments 28 days before starting the study and avoid certain medications like topical steroids and specific inhibitors 14 days before. If you're on any of these, you may need to stop or adjust them before participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that moxidectin might be a safe treatment for conditions beyond scabies in humans. It has successfully treated mange in animals, a condition similar to scabies. In humans, current safety data suggest it is generally well-tolerated. Although moxidectin is not yet approved for treating scabies in humans, ongoing studies aim to determine the right dose and ensure safety for this use. So far, researchers consider it safe enough for testing in this trial phase, which is encouraging. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for scabies?

Unlike the standard treatments for scabies, which typically include topical creams like permethrin or oral medications like ivermectin, moxidectin offers a novel approach. Moxidectin is unique because it uses a different active ingredient that may provide longer-lasting effects against the scabies mite. Researchers are excited about moxidectin due to its potential for a single-dose treatment, which could simplify scabies management and improve patient compliance. Moreover, the various dosages being tested (8mg, 16mg, and 32mg) allow for the possibility of optimizing the treatment's effectiveness and safety profile.

What evidence suggests that this trial's treatments could be effective for scabies?

Research has shown that moxidectin could be a promising treatment for scabies. Studies have found that a single dose of moxidectin outperforms the commonly used drug, ivermectin. In trials, moxidectin significantly reduced scabies symptoms, suggesting it could be a strong treatment option. Early studies also support this, demonstrating that moxidectin is more effective than other treatments. Therefore, there is good reason to believe that moxidectin might effectively treat scabies. ^{2 3 6 7 8}

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05875441

NCT05875441 | Efficacy and Safety Study of Moxidectin in ... 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5061321/

Preclinical Study of Single-Dose Moxidectin, a New Oral ... Our data demonstrate that oral single-dose MOX was more effective than two consecutive IVM-doses, supporting MOX as potential therapeutic ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0014489419305909

The scabicide effect of moxidectin in vitro and ... On conclusion, our results demonstrated that a single dose of MOX was more effective than IVM, supporting MOX as a valuable therapeutic approach for scabies ...

4. frontiersin.org frontiersin.org/journals/tropical-diseases/articles/10.3389/fitd.2024.1429266/epub

Scabies: current knowledge and future directions In clinical trials, moxidectin has demonstrated high efficacy against scabies. A single oral dose of moxidectin has significantly reduced ...

5. medicaljournals.se medicaljournals.se/acta/content/html/10.2340/00015555-3468

The Management of Scabies in the 21st Century Further studies found that treatment with 0.4 mg/kg ivermectin (a double dose) was approximately 95–100% effective (119). Similar results were ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4795782/

Prospects for Moxidectin as a New Oral Treatment for Human ... Moxidectin is very promising, given its proven clinical efficacy against mange in animals, existing safety data in humans, and pharmacokinetic properties.

7. journals.plos.org journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0005030

Preclinical Study of Single-Dose Moxidectin, a New Oral ... Our data demonstrate that oral single-dose MOX was more effective than two consecutive IVM-doses, supporting MOX as potential therapeutic approach for scabies.

8. ctv.veeva.com ctv.veeva.com/study/efficacy-and-safety-study-of-moxidectin-in-adults-with-scabies

Efficacy and Safety Study of Moxidectin in Adults With Scabies Moxidectin is not approved to treat scabies in humans. The effective dose of moxidectin to treat scabies is not known.