Scabies
Conditions
Keywords
Sarcoptes, Scabiei, Scabies, ectoparasite, parasite, infestation, Renaissance
Brief 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.
Detailed description
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.
Interventions
DRUGPermethrin Foam 4%
Topical application, whole-body treatment
DRUGPermethrin Foam 5%
Topical application, whole-body treatment
DRUGVehicle Foam
Topical application, whole-body treatment
Sponsors
DPT Laboratories, Ltd.
Vyne Therapeutics Inc.
Mylan Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Received a Single Treatment of the Assigned Test Article That Were Designated as Treatment Success | Day 28 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, Day 14, 28, and 42 | 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. |
| Number of Re-treated Subjects Designated as Treatment Success | Day 42 | 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. |
| Number of Subjects Designated as Treatment Success Following One Treatment With an Active Dose | Day 28 and Day 42 | 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. |
Countries
Dominican Republic, Honduras, Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 43 |
| 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 | 43 |
| Vehicle Foam First treatment with Vehicle with potential to re-treat with Permethrin Foam, if necessary.
Topical application, whole-body treatment | 44 |
| Total | 130 |
Baseline characteristics
| Characteristic | Permethrin Foam 4%/ Permethrin Foam 4% | Permethrin Foam 5%/ Permethrin Foam 5% | Vehicle Foam | Total |
|---|---|---|---|---|
| Age, Continuous | 28.1 years STANDARD_DEVIATION 20.8 | 23.4 years STANDARD_DEVIATION 18.4 | 26.1 years STANDARD_DEVIATION 20.4 | 25.9 years STANDARD_DEVIATION 19.8 |
| Sex: Female, Male Female | 24 Participants | 18 Participants | 19 Participants | 61 Participants |
| Sex: Female, Male Male | 19 Participants | 25 Participants | 25 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 51 | 0 / 52 | 0 / 44 |
| serious Total, serious adverse events | 0 / 51 | 0 / 52 | 0 / 44 |
Outcome results
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.
Time frame: Day 28
Population: Intent to Treat (ITT)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Permethrin Foam 4%/ Permethrin Foam 4% | Number of Subjects Who Received a Single Treatment of the Assigned Test Article That Were Designated as Treatment Success | 23 Participants |
| Permethrin Foam 5%/ Permethrin Foam 5% | Number of Subjects Who Received a Single Treatment of the Assigned Test Article That Were Designated as Treatment Success | 26 Participants |
| Vehicle Foam | Number of Subjects Who Received a Single Treatment of the Assigned Test Article That Were Designated as Treatment Success | 22 Participants |
p-value: 0.6084Chi-squared
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.
Time frame: Baseline, Day 14, 28, and 42
Population: Missing data not included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Permethrin Foam 4%/ Permethrin Foam 4% | 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 | Day 14 Change from Baseline | -1.1 score on a scale | Standard Deviation 2.7 |
| Permethrin Foam 4%/ Permethrin Foam 4% | 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 | Day 42 Change from Prior Visit (Day 28) | -0.5 score on a scale | Standard Deviation 4 |
| Permethrin Foam 4%/ Permethrin Foam 4% | 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 | Day 28 Change from Prior Visit (Day 14) | -11.2 score on a scale | Standard Deviation 4.5 |
| Permethrin Foam 5%/ Permethrin Foam 5% | 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 | Day 14 Change from Baseline | 0.6 score on a scale | Standard Deviation 2 |
| Permethrin Foam 5%/ Permethrin Foam 5% | 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 | Day 42 Change from Prior Visit (Day 28) | -2.5 score on a scale | Standard Deviation 2.9 |
| Permethrin Foam 5%/ Permethrin Foam 5% | 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 | Day 28 Change from Prior Visit (Day 14) | -9.0 score on a scale | Standard Deviation 5.9 |
| Vehicle Foam | 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 | Day 28 Change from Prior Visit (Day 14) | -11.4 score on a scale | Standard Deviation 6.7 |
| Vehicle Foam | 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 | Day 14 Change from Baseline | -0.1 score on a scale | Standard Deviation 2.5 |
| Vehicle Foam | 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 | Day 42 Change from Prior Visit (Day 28) | -2.4 score on a scale | Standard Deviation 2.4 |
| Vehicle Foam; Permethrin Foam 5% | 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 | Day 14 Change from Baseline | 0.6 score on a scale | Standard Deviation 3.5 |
| Vehicle Foam; Permethrin Foam 5% | 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 | Day 42 Change from Prior Visit (Day 28) | -3.4 score on a scale | Standard Deviation 6.6 |
| Vehicle Foam; Permethrin Foam 5% | 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 | Day 28 Change from Prior Visit (Day 14) | -9.7 score on a scale | Standard Deviation 7.7 |
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.
Time frame: Day 42
Population: ITT subjects who did not improve at Day 14 and received a second treatment at Day 14
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Permethrin Foam 4%/ Permethrin Foam 4% | Number of Re-treated Subjects Designated as Treatment Success | 8 Participants |
| Permethrin Foam 5%/ Permethrin Foam 5% | Number of Re-treated Subjects Designated as Treatment Success | 4 Participants |
| Vehicle Foam | Number of Re-treated Subjects Designated as Treatment Success | 5 Participants |
| Vehicle Foam; Permethrin Foam 5% | Number of Re-treated Subjects Designated as Treatment Success | 4 Participants |
p-value: 0.6937Chi-squared
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.
Time frame: Day 28 and Day 42
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Permethrin Foam 4%/ Permethrin Foam 4% | Number of Subjects Designated as Treatment Success Following One Treatment With an Active Dose | 8 Participants |
| Permethrin Foam 5%/ Permethrin Foam 5% | Number of Subjects Designated as Treatment Success Following One Treatment With an Active Dose | 4 Participants |
| Vehicle Foam | Number of Subjects Designated as Treatment Success Following One Treatment With an Active Dose | 28 Participants |
| Vehicle Foam; Permethrin Foam 5% | Number of Subjects Designated as Treatment Success Following One Treatment With an Active Dose | 30 Participants |
p-value: 0.101Fisher Exact
p-value: 0.0764Fisher Exact