- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05875441
Efficacy and Safety Study of Moxidectin in Adults With Scabies
November 30, 2023 updated by: Medicines Development for Global Health
A Phase 2, Placebo-controlled, Double-blind, Randomized, Dose Ranging, Efficacy and Safety Study of Orally Administered 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.
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.
This study also aims to assess the safety of three strengths of single moxidectin doses in adults with scabies.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Vidya Uprety
- Phone Number: +61(0)3 9912 2427
- Email: vidya.uprety@medicinesdevelopment.com
Study Locations
-
-
Cortes
-
San Pedro Sula, Cortes, Honduras, 21104
- Recruiting
- Hospital y Clinica Bendana
-
Contact:
- Jorge Lopez, MD
-
Principal Investigator:
- Jorge Lopez, MD
-
-
-
-
Florida
-
Miami, Florida, United States, 33155
- Recruiting
- Advanced Care and Clinical Trials, LLC
-
Principal Investigator:
- Richard Fernandez, MD
-
Contact:
- Ivan Garcia Alonso
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19103
- Recruiting
- Paddington Testing Company, Inc
-
-
Texas
-
Houston, Texas, United States, 77055
- Recruiting
- West Houston Clinical Research Service
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Aged 18 years or older.
- Provided written informed consent.
- Diagnosis of active scabies infestation confirmed by the presence of clinical signs and symptoms (evidence of burrows or typical inflammatory/noninflammatory lesions and pruritus) and either microscopic confirmation of scabies mite(s), ova or scybala by skin scraping or dermoscopy.
- 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).
Exclusion Criteria:
- Diagnosis of crusted/Norwegian scabies or scabies presentation that, in the opinion of the Investigator, would require treatment with more than one standard of care treatment for scabies (e.g., scabies requiring concurrent topical and oral treatment).
- History of chronic or recurrent dermatologic disease or skin conditions other than scabies that could interfere with the diagnosis of scabies and evaluation of cure.
- Received any treatment with one or more scabicides within the 28 days prior to Screening, or between Screening and Baseline, including but not limited to permethrin, ivermectin, benzyl benzoate, sulfur, lindane, crotamiton, malathion, tea tree oil or spinosad.
- Body mass index > 35 kg/m2.
- Creatinine clearance < 30 mL/min (using Cockcroft-Gault equation).
- Both total bilirubin >1.5 x upper limit of normal (ULN) and AST > ULN.
- Abnormal and clinically relevant findings in hematology or biochemistry assessments at Screening, or in vital signs, 12-lead ECG, or physical examination at Screening and/or Baseline, that in the opinion of the Investigator would put the subjects at increased risk from participating in the study, confound study evaluations, or may interfere with study conduct.
- Presence of any other clinically relevant condition, including infection, immunological disorder, malignant disease, and/or other underlying condition or circumstance at Screening or Baseline that in the opinion of the Investigator would put the subjects at increased risk from participating in the study, confound study evaluations, or interfere with the study conduct.
- Use of topical steroids, systemic or high-dose inhaled corticosteroids (>500 µg per day of fluticasone propionate or equivalent for adults), or other immunomodulators within 14 days of Baseline.
- Requiring ongoing treatment with, or received within 5 half-lives before Screening, any of the following medications that are clinical BCRP inhibitors: curcurmin (turmeric) supplements, cyclosporine A, darolutamide, eltrombopag, febuxostat, fostamatinib, rolapitant and teriflunomide.
- Received an investigational agent within 28 days of Screening (or 5 half-lives of the investigational agent, whichever is longer).
- Known or suspected hypersensitivity to macrocyclic lactones or excipients used in the formulation of moxidectin or ivermectin.
- Known or suspected hypersensitivity to any of the components in permethrin 5% cream, to any synthetic pyrethroid or pyrethrin, or to the components of spinosad 0.9% topical suspension.
- Known, suspected or at risk of Loa loa coinfection.
- Difficulty swallowing tablets or capsules.
- Pregnant or breastfeeding or planning to become pregnant from Screening until 16 weeks after treatment with IP.
- Known or suspected alcohol or illicit substance abuse.
- Unwilling, unlikely or unable to comply with all protocol specified assessments.
- Previous enrolment in this study.
- Previous moxidectin exposure within 6 months (5 half-lives) from Baseline.
- Has household members who refuse or are unable to receive permethrin 5% cream treatment for scabies.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Moxidectin 8mg
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.
|
The required number of moxidectin 2 mg tablet over encapsulated capsules will be administered as a single dose with placebo capsules to match as required
The required number of moxidectin 2 mg tablet over encapsulated capsules will be administered as a single dose.
|
Experimental: Moxidectin 16mg
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.
|
The required number of moxidectin 2 mg tablet over encapsulated capsules will be administered as a single dose with placebo capsules to match as required
The required number of moxidectin 2 mg tablet over encapsulated capsules will be administered as a single dose.
|
Experimental: Moxidectin 32mg
Moxidectin 32 mg (over encapsulated) will be administered as a single dose on Day 0.
|
The required number of moxidectin 2 mg tablet over encapsulated capsules will be administered as a single dose with placebo capsules to match as required
The required number of moxidectin 2 mg tablet over encapsulated capsules will be administered as a single dose.
|
Placebo Comparator: Placebo
16 Placebo capsules will be administered as a single dose on Day 0.
|
16 placebo capsules will be administered as a single dose.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of index subjects achieving complete cure (Efficacy)
Time Frame: 28 Days
|
Proportion of index subjects achieving Complete Cure at Day 28. Complete Cure is defined as demonstration of both:
|
28 Days
|
Incidence and severity of Treatment Emergent Adverse Event (Safety)
Time Frame: 84 Days
|
Incidence and severity of Treatment Emergent Adverse Event (TEAEs), Incidence of serious TEAEs and Incidence of TEAEs leading to study withdrawal and/or death.
|
84 Days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 28 Days
|
The proportion of index subjects demonstrating clinical cure without microscopic or dermatoscopic cure at Day 28.
|
28 Days
|
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.
Time Frame: 28 Days
|
The proportion of index subjects demonstrating microscopic or dermatoscopic cure without clinical cure at Day 28.
|
28 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Oscar De Valle, MD, West Houston Clinical Research Service
- Principal Investigator: Jennifer L Parish, MD, Paddington Testing Company, Inc
- Principal Investigator: Richard L Fernandez, MD, Advance Care and Clinical Trials
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 23, 2023
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
August 30, 2024
Study Registration Dates
First Submitted
May 16, 2023
First Submitted That Met QC Criteria
May 16, 2023
First Posted (Actual)
May 25, 2023
Study Record Updates
Last Update Posted (Actual)
December 4, 2023
Last Update Submitted That Met QC Criteria
November 30, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MDGH-MOX-2002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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