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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
Awards & highlights
Study Summary
This trial will assess the efficacy and safety of 3 moxidectin doses for scabies in adults. Results to determine safe and effective dose.
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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
Select...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and severity of Treatment Emergent Adverse Event (Safety)
Proportion of index subjects achieving complete cure (Efficacy)
Other outcome measures
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 • NCT0390526563%
Acarodermatitis
38%
Pruritus
25%
Headache
13%
Eczema
13%
Dermatitis
13%
Dizziness
13%
Uterine haemorrhage
13%
Rash papular
13%
Abortion spontaneous
100%
80%
60%
40%
20%
0%
Study treatment Arm
Moxidectin 36 mg
Moxidectin 8 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
Find a Location
Who is running the clinical trial?
Medicines Development for Global HealthLead Sponsor
8 Previous Clinical Trials
14,632 Total Patients Enrolled
1 Trials studying Scabies
22 Patients Enrolled for Scabies
Oscar De Valle, MDPrincipal InvestigatorWest Houston Clinical Research Service
Jennifer L Parish, MDPrincipal InvestigatorPaddington Testing Company, Inc
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am 18 years old or older.You are known to have severe allergies to certain medications.People I live with can't or won't use scabies cream.You have a known or suspected problem with drinking alcohol or using illegal drugs.I have been diagnosed with scabies confirmed by skin tests.I have a severe form of scabies that needs multiple treatments.I haven't used steroids or immune system medications in the last 14 days.I am currently taking, or have recently taken, medication that affects cancer cell growth.You weigh more than 250 pounds for someone who is 6 feet tall.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Moxidectin 16mg
- Group 3: Moxidectin 32mg
- Group 4: Moxidectin 8mg
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people have been recruited for inclusion in this research?
"Affirmative. The information accessible on clinicaltrials.gov shows that this trial, which was initially published on August 3rd 2023 is still recruiting participants. 200 individuals must be recruited between 2 different centres for the study to continue."
Answered by AI
Is there still room to join this research experiment?
"Affirmative. Documents hosted on clinicaltrials.gov demonstrate that this medical trial is currently in the recruitment phase, having been initially posted on August 3rd 2023 and recently updated on the same date. It requires a total of 200 individuals to be recruited at two different sites."
Answered by AI
Has Moxidectin 8mg garnered the endorsement of the FDA?
"Our team at Power believes that Moxidectin 8mg is moderately safe, giving it a score of 2. This assessment was based on the fact that this trial is currently in Phase 2; while some safety data exists, efficacy has not yet been established."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
Tennessee
What site did they apply to?
Paddington Testing Company, Inc
Advanced Care and Clinical Trials, LLC
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I want help getting rid of the mites. I have tried everything and nothing has gotten rid of what I have. The itching and the crawling sensations are unbearable at times. I also feel like I am being bitten occasionally.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
What is the dosage of Moxidectin for this trial?
PatientReceived 1 prior treatment
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