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| Name | Class |
|---|---|
| DPT Laboratories, Ltd. | INDUSTRY |
| Vyne Therapeutics Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Permethrin Foam 4%/ Permethrin Foam 4% | Experimental | First treatment with Permethrin Foam 4% with potential to re-treat with Permethrin Foam 4%, if necessary. |
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| Permethrin Foam 5%/ Permethrin Foam 5% | Experimental | First treatment with Permethrin Foam 5% with potential to re-treat with Permethrin Foam 5%, if necessary. |
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| Vehicle Foam / Permethrin Foam 4% | Placebo Comparator | First treatment with Vehicle with potential to re-treat with Permethrin Foam 4%, if necessary. |
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| Vehicle / Permethrin Foam 5% | Placebo Comparator | First treatment with Vehicle with potential to re-treat with Permethrin Foam 5%, if necessary. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Permethrin Foam 4% | Drug | Topical application, whole-body treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Site | Fremont | California | 94538 | United States | ||
| Clinical Research Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Permethrin Foam 4%/ Permethrin Foam 4% | First treatment with Permethrin Foam 4% with potential to re-treat with Permethrin Foam 4%, if necessary. Topical application, whole-body treatment |
| FG001 | Permethrin Foam 5%/ Permethrin Foam 5% |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Permethrin Foam 5% | Drug | Topical application, whole-body treatment |
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| Vehicle Foam | Drug | Topical application, whole-body treatment |
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| 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. | 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. | Day 28 and Day 42 |
| Los Angeles |
| California |
| 90036 |
| United States |
| Clinical Research Site | Hialeah | Florida | 33016 | United States |
| Clinical Research Site | New York | New York | 10018 | United States |
| Clinical Research Site | Philadelphia | Pennsylvania | 19103 | United States |
| Clinical Research Site | San Cristobal | Dominican Republic |
| Clinical Research Site | Santo Domingo | Dominican Republic |
| Clinical Research Site | San Pedro Sula | Honduras |
| Clinical Research Site | Ponce | 00716 | Puerto Rico |
First treatment with Permethrin Foam 5% with potential to re-treat with Permethrin Foam 5%, if necessary. Topical application, whole-body treatment |
| FG002 | Vehicle Foam | First treatment with Vehicle with potential to re-treat with Permethrin Foam, if necessary. Topical application, whole-body treatment |
| Received Second Dose at Day 14 | Of 44 subjects who had a first dose of vehicle, 8 received a second treatment with 4% and 9 with 5%. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Permethrin Foam 4%/ Permethrin Foam 4% | First treatment with Permethrin Foam 4% with potential to re-treat with Permethrin Foam 4%, if necessary. Topical application, whole-body treatment |
| BG001 | Permethrin Foam 5%/ Permethrin Foam 5% | First treatment with Permethrin Foam 5% with potential to re-treat with Permethrin Foam 5%, if necessary. Topical application, whole-body treatment |
| BG002 | Vehicle Foam | First treatment with Vehicle with potential to re-treat with Permethrin Foam, if necessary. Topical application, whole-body treatment |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent to Treat (ITT) | Posted | Count of Participants | Participants | Day 28 |
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| 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 | 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. | Missing data not included | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 14, 28, and 42 |
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| Secondary | 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. | ITT subjects who did not improve at Day 14 and received a second treatment at Day 14 | Posted | Count of Participants | Participants | Day 42 |
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| Secondary | 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. | Posted | Count of Participants | Participants | Day 28 and Day 42 |
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Subjects randomized to Vehicle/Permethrin Foam, 5% or Vehicle/Permethrin Foam, 4% who received a second treatment are counted in the Permethrin Foam, 5% or Permethrin Foam, 4% and Vehicle treatment groups. For subjects randomized to Vehicle Foam on Day 1 who were re-treated at Day 14 (Visit 3), Adverse Events (AEs) were assigned to Vehicle Foam group if the event occurred before Day 14 (Visit 3) or to the active treatment group if the event took place after Day 14 (Visit 3).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Permethrin Foam 4% | Treatment with Permethrin Foam 4%. Topical application, whole-body treatment | 0 | 51 | 0 | 51 | ||
| EG001 | Permethrin Foam 5% | Treatment with Permethrin Foam 5%. Topical application, whole-body treatment | 0 | 52 | 0 | 52 | ||
| EG002 | Vehicle Foam | Treatment with Vehicle Foam. Topical application, whole-body treatment | 0 | 44 | 0 | 44 |
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In the event said right to publish is exercised, the Investigator shall submit to Sponsor for review 60 days prior to any publication. In the event that Sponsor desires to take patent action, Investigator agrees to delay the publication an additional 60 days. Sponsor shall have the right to review and comment upon such publication. Notwithstanding the foregoing, no paper that incorporates Sponsor Confidential Information shall be submitted for publication without Sponsor's prior written consent.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Sciences Program Lead | Mylan Pharmaceuticals Pvt Ltd | prasannac.ganapathi@mylan.in |
| ID | Term |
|---|---|
| D012532 | Scabies |
| D010272 | Parasitic Diseases |
| ID | Term |
|---|---|
| D008924 | Mite Infestations |
| D004478 | Ectoparasitic Infestations |
| D012876 | Skin Diseases, Parasitic |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Male |
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First treatment with Permethrin Foam 5% with re-treatment with Permethrin Foam 5% at Day 14 who were also improving at Day 28. Topical application, whole-body treatment |
| OG002 | Vehicle; Permethrin Foam 4% | First treatment with Vehicle Foam with second treatment with Permethrin Foam 4% at Day 14 who were also improving at Day 28 Topical application, whole body treatment |
| OG003 | Vehicle Foam; Permethrin Foam 5% | First treatment with Vehicle with second treatment of Permethrin Foam 5% at Day 14 who were also improving at Day 28. Topical application, whole-body treatment |
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| OG003 | Vehicle; Permethrin Foam 5% | First treatment with Vehicle with potential to re-treat with Permethrin Foam 5%, if necessary. Topical application, whole-body treatment |
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If the subject was improved at Day 14 and only received one treatment (Permethrin Foam, 4%), or if the subject received Vehicle Foam at Baseline, was not improved at Day 14, and received a single active (Permethrin Foam, 4%) treatment at Day 14. Topical application, whole-body treatment |
| OG003 | Permethrin Foam 5% Single Active Treatment | If the subject was improved at Day 14 and only received one treatment (Permethrin Foam, 5%), or if the subject received Vehicle Foam at Baseline, was not improved at Day 14, and received a single active (Permethrin Foam, 5%) treatment at Day 14. Topical application, whole-body treatment |
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