Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being developed for the treatment of scabies, a skin condition caused by mites. It is a topical foam formulation that is currently in clinical development and has not been approved by the FDA.
Permethrin Foam 4% is being developed by Viatris Inc. (NASDAQ: VTRS). The company is conducting clinical trials to evaluate the safety and efficacy of this topical foam for the treatment of scabies.
Permethrin Foam 4% is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 2 trial has been completed, and the drug remains under investigation for the treatment of scabies.
Permethrin Foam 4% was studied in a completed Phase 2 clinical trial registered as NCT02094716. This was a dose-ranging, vehicle-controlled, double-blind, randomized study that enrolled 130 participants with scabies across the United States, Dominican Republic, Honduras, and Puerto Rico.
Permethrin Foam 4% and Permethrin Foam 5% are two different strengths of the same active ingredient, permethrin. Both were evaluated in the same Phase 2 clinical trial (NCT02094716) to determine their safety and efficacy for treating scabies, but they are distinct formulations.