ScabiesPhase 2NCT05875441
Efficacy and Safety Study of Moxidectin in Adults With Scabies
A Phase 2 study testing Moxidectin Oral Product in people with Scabies, run by Medicines Development for Global Health at 9 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scabies
- What is being tested?
- Moxidectin Oral Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 23 Nov 2023to 11 Feb 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
United States5 sites
LA Universal Research Center, Inc
Los Angeles, California, 90057
Evolution Clinical Trials
Miami, Florida, 33016
Advanced Care and Clinical Trials, LLC
Miami, Florida, 33155
Medical Research of Westchester, Inc
Miami, Florida, 33165
Affinity Clinical Research LLC
Tampa, Florida, 33612
Honduras2 sites
Derclinic
San Pedro Sula, Cortez, 21104
Hospital y Clinica Bendana
San Pedro Sula, Cortés Department, 21104
Dominican Republic1 site
Instituto Dermatologico Dominicano y Cirugia de Piel
Santo Domingo Oeste, Santo Domingo Province
El Salvador1 site
Vargas Clinic
San Salvador, San Salvador Department, 01101
About this study
Official title: 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.
- Conditions
- Scabies
- Being tested
- Moxidectin Oral Product, Placebo
- Keywords
- Moxidectin, Oral
- Medical subject headings
- Scabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxidectin Oral ProductDrug
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
Moxidectin Oral ProductDrug
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
Moxidectin Oral ProductDrug
The required number of moxidectin 2 mg tablet over encapsulated capsules will be administered as a single dose.
PlaceboDrug
16 placebo capsules will be administered as a single dose.
| Study group | Role | What they receive |
|---|---|---|
| Moxidectin 8mg | Experimental | 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. Receives: Drug: Moxidectin Oral Product |
| Moxidectin 16mg | Experimental | 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. Receives: Drug: Moxidectin Oral Product |
| Moxidectin 32mg | Experimental | Moxidectin 32 mg (over encapsulated) will be administered as a single dose on Day 0. Receives: Drug: Moxidectin Oral Product |
| Placebo | Placebo comparator | 16 Placebo capsules will be administered as a single dose on Day 0. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Index Subjects Achieving Complete Cure (Efficacy)
Complete Cure is defined as demonstration of both:
- Clinical cure: all signs and symptoms have completely resolved, including burrows, inflammatory/noninflammatory lesions and pruritus. And
- Microscopic or dermatoscopic cure demonstrating the absence of mites, eggs, and/or scybala, and negative dermoscopy for burrows.
Measured: 28 Days
Incidence and Severity of Treatment Emergent Adverse Event (Safety)
Incidence and severity of Treatment Emergent Adverse Event (TEAEs), Incidence of serious TEAEs and Incidence of TEAEs leading to study withdrawal and/or death. The analysis of adverse events (AEs) was focused on treatment emergent adverse events (TEAEs), defined as AEs that started, or worsened, on or after the start of the administration of IP.
Measured: Day 0 to Week 16 inclusive.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start23 Nov 2023
- Primary completion27 Nov 2024
- Study completion11 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ScabiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo-controlled, double-blind, randomized, dose ranging study. Four cohorts of 50 subjects per cohort are planned. Subjects will be randomized 1:1:1:1 to receive Moxidectin 8mg, Moxidectin 16mg, Moxidectin 32mg or Placebo as a single oral dose.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicines Development for Global Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard L Fernandez, MD, Principal investigator, Advance Care and Clinical TrialsJorge Lopez, MD, Principal investigator, Hospital y Clinica BendanaDaisy Blanco, MD, Principal investigator, Instituto Dermatologico Dominicano y Cirugia de PieJorge Castillo Molina, MD, Principal investigator, Affinity Clinical Research ServicesPatricia A Zuniga Munoz, MD, Principal investigator, DerclinicLaura B Vargas Rivas, MD, Principal investigator, Vargas ClinicGilberto Perez, MD, Principal investigator, Evolution Clinical TrialsArmando Pineda-Velez, MD, Principal investigator, Medical Research of Westchester, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875441
- Sponsor's protocol ID
- MDGH-MOX-2002
- Status last verified
- May 2025
- First submitted
- 16 May 2023
- Last updated
- 16 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data in the form of data listings and datasets may be available for sharing on application to the Sponsor.