Phase 2
N=130
A Dose Ranging Vehicle Controlled Study to Determine the Safety and Efficacy of Permethrin Foam, 5% and Permethrin Foam, 4% for the Treatment of Scabies
Scabies
Bottom Line
View on ClinicalTrials.gov: NCT02094716 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Number of Subjects Who Received a Single Treatment of the Assigned Test Article That Were Designated as "Treatment Success" — 23; 26; 22 Participants — p=0.6084
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Permethrin Foam 4% (Drug); Permethrin Foam 5% (Drug); Vehicle Foam (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Mylan Inc.
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Who Received a Single Treatment of the Assigned Test Article That Were Designated as "Treatment Success" |
23; 26; 22 | 0.6084 |
| SECONDARY Change in Disease-related Signs and Symptoms for Those Subjects Provided With Re-treatment at Day 14 Who Show Improvement in Their Investigator's Global Assessment (IGA) Score at Day 28 |
-1.1; 0.6; -0.1; 0.6; -11.2; -9.0 | — |
| SECONDARY Number of Re-treated Subjects Designated as "Treatment Success" |
8; 4; 5; 4 | 0.6937 |
| SECONDARY Number of Subjects Designated as "Treatment Success" Following One Treatment With an Active Dose |
8; 4; 28; 30 | 0.1010 |
Summary
To determine and compare the safety and efficacy of permethrin foam 4% and permethrin foam 5% with that of vehicle in subjects with scabies.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of active scabies infection.
- Subject is in good general health with normal appearing skin in noninfested areas.
- Females must be post-menopausal, surgically sterile or use an effective method of birth control with a negative pregnancy test (10 years of age and older) at study start.
Exclusion Criteria
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject has used any ectoparasiticide within the three weeks prior to study start.
- Subject has signs of systemic infection or is receiving systemic therapy for an infectious disease.
- Subject has severe cutaneous bacterial or fungal infections requiring therapy or heavily crusted lesions consistent with Norwegian scabies.
- Subject is currently enrolled in an investigational drug or device study or has used an investigational drug or device within 30 days prior to study start.
- Subject whose close personal contacts will not comply with standard of care for fomite management.
Data sourced from ClinicalTrials.gov (NCT02094716). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.