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Also known as PF-045
Permethrin Foam 4% · 1 trial · 1 indication
The primary efficacy variable is "treatment success". In protocol v2.0, "treatment success" was defined as an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear). In protocol v3.0, "treatment success" was defined as an "eradication of infestation": a) no burrows, b) a reduction in the Signs/Symptoms, and c) no evidence of a live mite on microscopy.
| Arm | Type | Description |
|---|---|---|
| Permethrin Foam 4%/ Permethrin Foam 4% | EXPERIMENTAL | First treatment with Permethrin Foam 4% with potential to re-treat with Permethrin Foam 4%, if necessary. |
| Permethrin Foam 5%/ Permethrin Foam 5% | EXPERIMENTAL | First treatment with Permethrin Foam 5% with potential to re-treat with Permethrin Foam 5%, if necessary. |
| Vehicle Foam / Permethrin Foam 4% | PLACEBO_COMPARATOR | First treatment with Vehicle with potential to re-treat with Permethrin Foam 4%, if necessary. |
| Vehicle / Permethrin Foam 5% | PLACEBO_COMPARATOR | First treatment with Vehicle with potential to re-treat with Permethrin Foam 5%, if necessary. |
| Name | Type | Description |
|---|---|---|
| Permethrin Foam 4% | DRUG | Topical application, whole-body treatment |
| Permethrin Foam 5% | DRUG | Topical application, whole-body treatment |
| Vehicle Foam | DRUG | Topical application, whole-body treatment |
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 ag...
Permethrin Foam 4% is an investigational small molecule formulation being developed by Viatris Inc. (ticker: VTRS) for the treatment of scabies. It is a foam-based topical product containing permethrin at a 4% concentration. The drug is in Phase 2 clinical development and has not been approved by the FDA.
Permethrin Foam 4% is being studied for the treatment of scabies, a skin infestation caused by the mite Sarcoptes scabiei. The Phase 2 trial enrolled patients with scabies, including children as young as 6 months old. The condition is the sole indication under investigation for this formulation.
Permethrin Foam 4% is being developed by Viatris Inc., a pharmaceutical company traded on the Nasdaq under the ticker VTRS. Viatris is the sponsor of the clinical program evaluating this formulation for scabies.
Permethrin Foam 4% is in Phase 2 clinical development. The program includes one completed Phase 2 trial, and no active trials are currently listed. The drug remains investigational and has not received FDA approval for any indication.
Permethrin Foam 4% has been evaluated in a single Phase 2 trial, NCT02094716, titled "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." The trial was completed, enrolled 130 participants, and was conducted in the United States, Dominican Republic, Honduras, and Puerto Rico.