A Phase 2 interventional study of Permethrin Foam 4% and Permethrin Foam 5% in Scabies, sponsored by Mylan Inc.. Completed at 9 sites in 4 countries. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2023-04-26.
Sponsored by Mylan Inc. (part of Viatris Inc.) · Phase 2, Interventional, and Treatment
To determine and compare the safety and efficacy of permethrin foam 4% and permethrin foam 5% with that of vehicle in subjects with scabies.
It is anticipated that a majority of subjects will require and receive a single treatment; however, those subjects not showing improvement at the follow-up visit 2 weeks after initial treatment will be treated a second time. Those subjects originally assigned to vehicle for the first treatment will receive a "re-treatment" with one of the active doses.
51 studies on the registry are indexed under Scabies; 10 are open to participants now.
This study's enrollment of 130 is below the median of 183 across 41 interventional studies indexed under Scabies.
Browse Scabies studies →Mylan Inc. is the lead sponsor of 44 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 9 (100%) have results posted.
First submitted before Mylan Inc. became part of Viatris Inc..
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
First treatment with Permethrin Foam 4% with potential to re-treat with Permethrin Foam 4%, if necessary.
Drug: Permethrin Foam 4%
First treatment with Permethrin Foam 5% with potential to re-treat with Permethrin Foam 5%, if necessary.
Drug: Permethrin Foam 5%
First treatment with Vehicle with potential to re-treat with Permethrin Foam 4%, if necessary.
Drug: Permethrin Foam 4% · Drug: Vehicle Foam
First treatment with Vehicle with potential to re-treat with Permethrin Foam 5%, if necessary.
Drug: Permethrin Foam 5% · Drug: Vehicle Foam
Topical application, whole-body treatment
Also known as: PF-045
Topical application, whole-body treatment
Also known as: PF-055
Topical application, whole-body treatment
Also known as: Vehicle
Number of Subjects Who Received a Single Treatment of the Assigned Test Article That Were Designated as "Treatment Success"
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.
Time frame: Day 28
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
The change in the total score of signs and symptoms related to the condition in each treatment group at Days 14 and 28, as well as at Day 42 for those subjects provided with re-treatment at Day 14 who show improvement in their IGA score at Day 28. Scale details: The overall average presence of the individual signs and symptoms of scabies was evaluated over the entire body. Erythema, papules, pustules, crusting, scaling, excoriations, and pruritus were assessed as follows for each sign and symptom: None=0, Trace=1, Mild=2, Moderate=3, Severe=4. From these assessments, the total score of the Signs and Symptoms (from 0 to 28, higher scores mean a worse outcome) was calculated as the sum of the individual signs and symptoms scores at Baseline and Days 2, 14, 28, and 42 (if applicable).The change from baseline in the total score can range from -28 as the best reduction possible (better outcome) to +28 as the worst increase possible (worse outcome) in signs and symptoms.
Time frame: Baseline, Day 14, 28, and 42
Number of Re-treated Subjects Designated as "Treatment Success"
Each subject was designated as "re-treatment success" at Day 42 based upon the criteria in the protocol to which he/she was enrolled. 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.
Time frame: Day 42
Number of Subjects Designated as "Treatment Success" Following One Treatment With an Active Dose
The proportion of subjects designated as "treatment success" following one treatment versus two treatments. 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. Subjects originally assigned to vehicle treatment and re-treated on Day 14 with an active dose will be included with the single treatment group for this analysis. Subjects who did not improve at Day 14 were counted as failures at Day 28. Subjects who improved at Day 14 and received a second treatment in error were counted as failures at Day 28.
Time frame: Day 28 and Day 42
| Milestone | Permethrin Foam 4%/ Permethrin Foam 4% | Permethrin Foam 5%/ Permethrin Foam 5% | Vehicle Foam |
|---|---|---|---|
| Started | 43 | 43 | 44 |
| Received second dose at day 14 | 15 | 10 | 17 |
| Completed | 41 | 36 | 40 |
| Not completed | 2 | 7 | 4 |
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.
| Participants | Permethrin Foam 4%/ Permethrin Foam 4% | Permethrin Foam 5%/ Permethrin Foam 5% | Vehicle Foam |
|---|---|---|---|
| Number of Subjects Who Received a Single Treatment of the Assigned Test Article That Were Designated as "Treatment Success" | 23 | 26 | 22 |
The change in the total score of signs and symptoms related to the condition in each treatment group at Days 14 and 28, as well as at Day 42 for those subjects provided with re-treatment at Day 14 who show improvement in their IGA score at Day 28. Scale details: The overall average presence of the individual signs and symptoms of scabies was evaluated over the entire body. Erythema, papules, pustules, crusting, scaling, excoriations, and pruritus were assessed as follows for each sign and symptom: None=0, Trace=1, Mild=2, Moderate=3, Severe=4. From these assessments, the total score of the Signs and Symptoms (from 0 to 28, higher scores mean a worse outcome) was calculated as the sum of the individual signs and symptoms scores at Baseline and Days 2, 14, 28, and 42 (if applicable).The change from baseline in the total score can range from -28 as the best reduction possible (better outcome) to +28 as the worst increase possible (worse outcome) in signs and symptoms.
| score on a scale | Permethrin Foam 4%; Permethrin Foam 4% | Permethrin Foam 5%; Permethrin Foam 5% | Vehicle; Permethrin Foam 4% | Vehicle Foam; Permethrin Foam 5% |
|---|---|---|---|---|
| Day 14 Change from Baseline | -1.1 ± 2.7 | 0.6 ± 2.0 | -0.1 ± 2.5 | 0.6 ± 3.5 |
| Day 28 Change from Prior Visit (Day 14) | -11.2 ± 4.5 | -9.0 ± 5.9 | -11.4 ± 6.7 | -9.7 ± 7.7 |
| Day 42 Change from Prior Visit (Day 28) | -0.5 ± 4.0 | -2.5 ± 2.9 | -2.4 ± 2.4 | -3.4 ± 6.6 |
Each subject was designated as "re-treatment success" at Day 42 based upon the criteria in the protocol to which he/she was enrolled. 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.
| Participants | Permethrin Foam 4%; Permethrin Foam 4% | Permethrin Foam 5%; Permethrin Foam 5% | Vehicle Foam; Permethrin Foam 4% | Vehicle; Permethrin Foam 5% |
|---|---|---|---|---|
| Number of Re-treated Subjects Designated as "Treatment Success" | 8 | 4 | 5 | 4 |
The proportion of subjects designated as "treatment success" following one treatment versus two treatments. 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. Subjects originally assigned to vehicle treatment and re-treated on Day 14 with an active dose will be included with the single treatment group for this analysis. Subjects who did not improve at Day 14 were counted as failures at Day 28. Subjects who improved at Day 14 and received a second treatment in error were counted as failures at Day 28.
| Participants | Permethrin Foam 4% Two Active Treatments | Permethrin Foam 5% Two Active Treatments | Permethrin Foam 4% Single Active Treatment | Permethrin Foam 5% Single Active Treatment |
|---|---|---|---|---|
| Number of Subjects Designated as "Treatment Success" Following One Treatment With an Active Dose | 8 | 4 | 28 | 30 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Permethrin Foam 4% | — | 0/51 (0%) | 0/51 (0%) |
| Permethrin Foam 5% | — | 0/52 (0%) | 0/52 (0%) |
| Vehicle Foam | — | 0/44 (0%) | 0/44 (0%) |
| Age, Continuous(years) | Permethrin Foam 4%/ Permethrin Foam 4% | Permethrin Foam 5%/ Permethrin Foam 5% | Vehicle Foam | Total |
|---|---|---|---|---|
| Mean | 28.1 ± 20.8 | 23.4 ± 18.4 | 26.1 ± 20.4 | 25.9 ± 19.8 |
| Sex: Female, Male(Participants) | Permethrin Foam 4%/ Permethrin Foam 4% | Permethrin Foam 5%/ Permethrin Foam 5% | Vehicle Foam | Total |
|---|---|---|---|---|
| Female | 24 | 18 | 19 | 61 |
| Male | 19 | 25 | 25 | 69 |
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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