Trial Outcomes & Findings for Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies (NCT NCT02485717)
NCT ID: NCT02485717
Last Updated: 2021-05-19
Results Overview
The primary efficacy assessment is the proportion of index subjects completely cured of scabies by Day 28. Complete cure is defined as a demonstration of both clinical cure (all signs and symptoms have completely resolved, including burrows, inflammatory/non-inflammatory lesions and pruritus) and microscopic or dermatoscopic cure demonstrating the absence of mites, eggs, and/or scybala, and a negative dermatoscopy for burrows.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
291 participants
Primary outcome timeframe
28 days after treatment
Results posted on
2021-05-19
Participant Flow
Exclusion Criteria #2 - Has a household member(s) who is not willing or not eligible to enroll. Exclusion Criteria #12 - Administration of systemic therapy for infectious disease within the prior 2 weeks.
Participant milestones
| Measure |
Natroba (Spinosad)
spinosad topical suspension, 0.9% up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours
spinosad topical suspension, 0.9%: Topically apply 0.9% suspension up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.
|
Placebo
placebo is a topical suspension that is the same formulation as Natroba without the active ingredient spinosad. Up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours.
placebo: Placebo is the same as the drug minus the active ingredient spinosad (vehicle). Topically apply up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.
|
PK Natroba (Spinosad)
open-label spinosad topical suspension, 0.9% up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours
open-label spinosad topical suspension, 0.9%: Topically apply 0.9% suspension up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.
|
|---|---|---|---|
|
Overall Study
STARTED
|
142
|
129
|
20
|
|
Overall Study
COMPLETED
|
136
|
127
|
19
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
1
|
Reasons for withdrawal
| Measure |
Natroba (Spinosad)
spinosad topical suspension, 0.9% up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours
spinosad topical suspension, 0.9%: Topically apply 0.9% suspension up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.
|
Placebo
placebo is a topical suspension that is the same formulation as Natroba without the active ingredient spinosad. Up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours.
placebo: Placebo is the same as the drug minus the active ingredient spinosad (vehicle). Topically apply up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.
|
PK Natroba (Spinosad)
open-label spinosad topical suspension, 0.9% up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours
open-label spinosad topical suspension, 0.9%: Topically apply 0.9% suspension up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Did Not Meet Exclusion Criteria #2
|
0
|
1
|
0
|
|
Overall Study
Did Not Meet Exclusion Criteria #12
|
0
|
1
|
0
|
Baseline Characteristics
Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies
Baseline characteristics by cohort
| Measure |
Natroba (Spinosad)
n=142 Participants
spinosad topical suspension, 0.9% up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours
spinosad topical suspension, 0.9%: Topically apply 0.9% suspension up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.
|
Placebo
n=129 Participants
placebo is a topical suspension that is the same formulation as Natroba without the active ingredient spinosad. Up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours.
Placebo: Placebo is the same as the drug minus the active ingredient spinosad (vehicle). Topically apply up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.
|
PK Natroba (Spinosad)
n=20 Participants
open-label spinosad topical suspension, 0.9% up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours
open-label spinosad topical suspension, 0.9%: Topically apply 0.9% suspension up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.
|
Total
n=291 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
30 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
85 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
94 Participants
n=93 Participants
|
82 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
176 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
|
Age, Continuous
|
38.7 Years
n=93 Participants
|
38.4 Years
n=4 Participants
|
9.6 Years
n=27 Participants
|
36.5 Years
n=483 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=93 Participants
|
70 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
151 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
140 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
130 Participants
n=93 Participants
|
121 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
266 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
142 participants
n=93 Participants
|
129 participants
n=4 Participants
|
20 participants
n=27 Participants
|
336 participants
n=483 Participants
|
|
Evidence of Burrows
|
38 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
86 Participants
n=483 Participants
|
|
Evidence of Lesions
|
63 Participants
n=93 Participants
|
69 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
152 Participants
n=483 Participants
|
|
Evidence of Pruritus
|
71 Participants
n=93 Participants
|
75 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
166 Participants
n=483 Participants
|
|
Total Number of Pre-existing Lesions
|
10.8 lesions
n=93 Participants
|
11.3 lesions
n=4 Participants
|
12.0 lesions
n=27 Participants
|
11.1 lesions
n=483 Participants
|
|
Score of Pre-existing Lesions
Free of Lesions
|
79 Participants
n=93 Participants
|
60 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
139 Participants
n=483 Participants
|
|
Score of Pre-existing Lesions
≤ 10 Lesions (Mild)
|
20 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
57 Participants
n=483 Participants
|
|
Score of Pre-existing Lesions
11-49 Lesions (Moderate)
|
40 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
86 Participants
n=483 Participants
|
|
Score of Pre-existing Lesions
≥ 50 Lesions (Severe)
|
3 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Microscopic/Dermatoscopy Result
Negative
|
73 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
132 Participants
n=483 Participants
|
|
Microscopic/Dermatoscopy Result
Positive
|
63 Participants
n=93 Participants
|
68 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
151 Participants
n=483 Participants
|
|
Microscopic/Dermatoscopy Result
Not Done
|
6 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
|
Active Scabies Infestation
|
63 Participants
n=93 Participants
|
68 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
151 Participants
n=483 Participants
|
|
Prior Scabies Infestation
|
28 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
60 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 28 days after treatmentPopulation: Participants analyzed are based on the number of subjects who had no missing observations in each study group.
The primary efficacy assessment is the proportion of index subjects completely cured of scabies by Day 28. Complete cure is defined as a demonstration of both clinical cure (all signs and symptoms have completely resolved, including burrows, inflammatory/non-inflammatory lesions and pruritus) and microscopic or dermatoscopic cure demonstrating the absence of mites, eggs, and/or scybala, and a negative dermatoscopy for burrows.
Outcome measures
| Measure |
Natroba (Spinosad)
n=43 Participants
spinosad topical suspension, 0.9% up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours
spinosad topical suspension, 0.9%: Topically apply 0.9% suspension up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.
|
Placebo
n=43 Participants
placebo is a topical suspension that is the same formulation as Natroba without the active ingredient spinosad. Up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours.
Placebo: Placebo is the same as the drug minus the active ingredient spinosad (vehicle). Topically apply up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.
|
|---|---|---|
|
Number of Index Subjects Completely Cured of Scabies After a Single Treatment
|
30 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 12 HoursOutcome measures
| Measure |
Natroba (Spinosad)
n=19 Participants
spinosad topical suspension, 0.9% up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours
spinosad topical suspension, 0.9%: Topically apply 0.9% suspension up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.
|
Placebo
placebo is a topical suspension that is the same formulation as Natroba without the active ingredient spinosad. Up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours.
Placebo: Placebo is the same as the drug minus the active ingredient spinosad (vehicle). Topically apply up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.
|
|---|---|---|
|
This Assessment Includes Assessing the Cmax (μg/mL) of Benzyl Alcohol Pre-dose and During 12 Hours Post-dose of Natroba™ in Pediatric Subjects (Ages 4-16 Years).
|
2.737 μg/mL
Standard Deviation 1.107
|
—
|
SECONDARY outcome
Timeframe: 12 HoursOutcome measures
| Measure |
Natroba (Spinosad)
n=19 Participants
spinosad topical suspension, 0.9% up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours
spinosad topical suspension, 0.9%: Topically apply 0.9% suspension up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.
|
Placebo
placebo is a topical suspension that is the same formulation as Natroba without the active ingredient spinosad. Up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours.
Placebo: Placebo is the same as the drug minus the active ingredient spinosad (vehicle). Topically apply up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.
|
|---|---|---|
|
This Assessment Includes Assessing the Tmax (Hours) of Benzyl Alcohol Pre-dose and During 12 Hours Post-dose of Natroba™ in Pediatric Subjects (Ages 4-16 Years).
|
1.42 hours
Standard Deviation 1.242
|
—
|
SECONDARY outcome
Timeframe: 12 HoursOutcome measures
| Measure |
Natroba (Spinosad)
n=19 Participants
spinosad topical suspension, 0.9% up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours
spinosad topical suspension, 0.9%: Topically apply 0.9% suspension up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.
|
Placebo
placebo is a topical suspension that is the same formulation as Natroba without the active ingredient spinosad. Up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours.
Placebo: Placebo is the same as the drug minus the active ingredient spinosad (vehicle). Topically apply up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.
|
|---|---|---|
|
This Assessment Includes Assessing the AUC 0-12h (μg•h/mL) of Benzyl Alcohol Pre-dose and During 12 Hours Post-dose of Natroba™ in Pediatric Subjects (Ages 4-16 Years).
|
19.240 μg•h/mL
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: 12 HoursNote: All of the spinosad (spinosyn A and spinosyn D) plasma levels tested were below the limit of quantification (3 ng/mL). Therefore, the mean and standard deviation of Cmax read "0" in the Outcome Measure Data Table.
Outcome measures
| Measure |
Natroba (Spinosad)
n=19 Participants
spinosad topical suspension, 0.9% up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours
spinosad topical suspension, 0.9%: Topically apply 0.9% suspension up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.
|
Placebo
placebo is a topical suspension that is the same formulation as Natroba without the active ingredient spinosad. Up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours.
Placebo: Placebo is the same as the drug minus the active ingredient spinosad (vehicle). Topically apply up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.
|
|---|---|---|
|
This Assessment Includes Assessing the Cmax (ng/mL) of Spinosad (Spinosyn A and Spinosyn D) Pre-dose and During 12 Hours Post-dose of Natroba™ in Pediatric Subjects (Ages 4-16 Years).
|
0 ng/mL
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: 12 HoursNote: All of the spinosad (spinosyn A and spinosyn D) plasma levels tested were below the limit of quantification (3 ng/mL). Therefore, the mean and standard deviation of Tmax read "0" in the Outcome Measure Data Table.
Outcome measures
| Measure |
Natroba (Spinosad)
n=19 Participants
spinosad topical suspension, 0.9% up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours
spinosad topical suspension, 0.9%: Topically apply 0.9% suspension up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.
|
Placebo
placebo is a topical suspension that is the same formulation as Natroba without the active ingredient spinosad. Up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours.
Placebo: Placebo is the same as the drug minus the active ingredient spinosad (vehicle). Topically apply up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.
|
|---|---|---|
|
This Assessment Includes Assessing the Tmax (Hours) of Spinosad (Spinosyn A and Spinosyn D) Pre-dose and During 12 Hours Post-dose of Natroba™ in Pediatric Subjects (Ages 4-16 Years).
|
0 hours
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: 12 HoursNote: All of the spinosad (spinosyn A and spinosyn D) plasma levels tested were below the limit of quantification (3 ng/mL). Therefore, the mean and standard deviation of AUC 0-12h read "0" in the Outcome Measure Data Table.
Outcome measures
| Measure |
Natroba (Spinosad)
n=19 Participants
spinosad topical suspension, 0.9% up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours
spinosad topical suspension, 0.9%: Topically apply 0.9% suspension up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.
|
Placebo
placebo is a topical suspension that is the same formulation as Natroba without the active ingredient spinosad. Up to 120 mL (enough product is used to cover the body from the neck down to the soles of the feet), one treatment left on for 6 hours.
Placebo: Placebo is the same as the drug minus the active ingredient spinosad (vehicle). Topically apply up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.
|
|---|---|---|
|
This Assessment Includes Assessing the AUC 0-12h (ng•h/mL) of Spinosad (Spinosyn A and Spinosyn D) Pre-dose and During 12 Hours Post-dose of Natroba™ in Pediatric Subjects (Ages 4-16 Years).
|
0 ng•h/mL
Standard Deviation 0
|
—
|
Adverse Events
Natroba (Spinosad)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PK Natroba (Spinosad)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Site may not publish or publicly present Study results. If Sponsor has given its prior written consent to the Site to publish or present Study results, Site will provide Sponsor with a copy of any proposed oral or written publication to at least sixty (60) days in advance of submission for publication or presentation for review and comment on the appropriateness of the data analysis and presentation. The terms of this paragraph shall survive expiration or termination of this Agreement.
- Publication restrictions are in place
Restriction type: OTHER