Trial Outcomes & Findings for Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies (NCT NCT02485704)

Last Updated: 2021-05-21

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

280 participants

Primary outcome timeframe

28 days after treatment

Results posted on

2021-05-21

Participant Flow

18 subjects were excluded from the ITT (intent-to-treat), I-ITT (index intent-to-treat), and I-PP (index per protocol) populations due to noncompliance with the randomization procedures. As such, only 262 subjects (145 in the Natroba group and 117 in the placebo group) were included in the ITT population.

Inclusion Criteria #2 - At least one household member must have active scabies infestation confirmed.

Participant milestones

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 (vehicle). 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.
Overall Study STARTED	154	126
Overall Study COMPLETED	149	118
Overall Study NOT COMPLETED	5	8

Reasons for withdrawal

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 (vehicle). 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.
Overall Study Lost to Follow-up	4	5
Overall Study Withdrawal by Subject	0	3
Overall Study Did Not Meet Inclusion Criteria #2	1	0

Baseline Characteristics

A score of pre-existing lesions was not done for one of the Natroba (spinosad) participants. Therefore, 144 Natroba (spinosad) participants out of 145 Natroba (spinosad) participants were scored for pre-existing lesions.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Natroba (Spinosad) n=145 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=117 Participants Placebo is a topical suspension that is the same formulation as Natroba without the active ingredient, spinosad (vehicle). 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.	Total n=262 Participants Total of all reporting groups
Age, Categorical <=18 years	47 Participants n=145 Participants	38 Participants n=117 Participants	85 Participants n=262 Participants
Age, Categorical Between 18 and 65 years	84 Participants n=145 Participants	76 Participants n=117 Participants	160 Participants n=262 Participants
Age, Categorical >=65 years	14 Participants n=145 Participants	3 Participants n=117 Participants	17 Participants n=262 Participants
Age, Continuous	33.7 years n=145 Participants	31.7 years n=117 Participants	32.8 years n=262 Participants
Sex: Female, Male Female	78 Participants n=145 Participants	67 Participants n=117 Participants	145 Participants n=262 Participants
Sex: Female, Male Male	67 Participants n=145 Participants	50 Participants n=117 Participants	117 Participants n=262 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=145 Participants	0 Participants n=117 Participants	0 Participants n=262 Participants
Race (NIH/OMB) Asian	7 Participants n=145 Participants	7 Participants n=117 Participants	14 Participants n=262 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=145 Participants	2 Participants n=117 Participants	2 Participants n=262 Participants
Race (NIH/OMB) Black or African American	24 Participants n=145 Participants	14 Participants n=117 Participants	38 Participants n=262 Participants
Race (NIH/OMB) White	112 Participants n=145 Participants	92 Participants n=117 Participants	204 Participants n=262 Participants
Race (NIH/OMB) More than one race	0 Participants n=145 Participants	0 Participants n=117 Participants	0 Participants n=262 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=145 Participants	2 Participants n=117 Participants	4 Participants n=262 Participants
Region of Enrollment United States	145 participants n=145 Participants	117 participants n=117 Participants	262 participants n=262 Participants
Evidence of Burrows	90 Participants n=145 Participants	68 Participants n=117 Participants	158 Participants n=262 Participants
Evidence of Lesions	103 Participants n=145 Participants	79 Participants n=117 Participants	182 Participants n=262 Participants
Evidence of Pruritus	113 Participants n=145 Participants	89 Participants n=117 Participants	202 Participants n=262 Participants
Total Number of Pre-existing Lesions	8.6 lesions n=144 Participants • A score of pre-existing lesions was not done for one of the Natroba (spinosad) participants. Therefore, 144 Natroba (spinosad) participants out of 145 Natroba (spinosad) participants were scored for pre-existing lesions.	7.7 lesions n=117 Participants • A score of pre-existing lesions was not done for one of the Natroba (spinosad) participants. Therefore, 144 Natroba (spinosad) participants out of 145 Natroba (spinosad) participants were scored for pre-existing lesions.	8.2 lesions n=261 Participants • A score of pre-existing lesions was not done for one of the Natroba (spinosad) participants. Therefore, 144 Natroba (spinosad) participants out of 145 Natroba (spinosad) participants were scored for pre-existing lesions.
Score of Pre-Existing Lesions Free of Lesions	41 Participants n=145 Participants	38 Participants n=117 Participants	79 Participants n=262 Participants
Score of Pre-Existing Lesions ≤ 10 Lesions (Mild)	48 Participants n=145 Participants	34 Participants n=117 Participants	82 Participants n=262 Participants
Score of Pre-Existing Lesions 11-49 Lesions (Moderate)	55 Participants n=145 Participants	45 Participants n=117 Participants	100 Participants n=262 Participants
Score of Pre-Existing Lesions ≥ 50 Lesions (Severe)	0 Participants n=145 Participants	0 Participants n=117 Participants	0 Participants n=262 Participants
Score of Pre-Existing Lesions Not Done	1 Participants n=145 Participants	0 Participants n=117 Participants	1 Participants n=262 Participants
Microscopy/Dermatoscopy Result Negative	53 Participants n=145 Participants	48 Participants n=117 Participants	101 Participants n=262 Participants
Microscopy/Dermatoscopy Result Positive	92 Participants n=145 Participants	69 Participants n=117 Participants	161 Participants n=262 Participants
Active Scabies Infestation	92 Participants n=145 Participants	69 Participants n=117 Participants	161 Participants n=262 Participants
Prior Scabies Infestation	68 Participants n=145 Participants	68 Participants n=117 Participants	136 Participants n=262 Participants

PRIMARY outcome

Timeframe: 28 days after treatment

Population: Participants analyzed are based on the number of subjects who had no missing observations in each study group.

Outcome measures

Outcome measures
Measure	Natroba (Spinosad) n=62 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=58 Participants placebo is a topical suspension that is the same formulation as Natroba without the active ingredient spinosad (vehicle). 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	52 Participants	20 Participants

Adverse Events

Natroba (Spinosad)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Natroba (Spinosad) n=145 participants at risk 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=135 participants at risk placebo is a topical suspension that is the same formulation as Natroba without the active ingredient spinosad (vehicle). 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.
Skin and subcutaneous tissue disorders Dry Skin	0.69% 1/145 • 1 year, 2 months Following randomization, 9 subjects were inaccurately dispensed Placebo instead of Natroba. Therefore, the safety population for the Natroba Arm/Group was 145 subjects (instead of the 154 randomized subjects who Started in Participant Flow) and the safety population for the Placebo Arm/Group was 135 subjects (instead of the 126 randomized subjects who Started in Participant Flow).	0.00% 0/135 • 1 year, 2 months Following randomization, 9 subjects were inaccurately dispensed Placebo instead of Natroba. Therefore, the safety population for the Natroba Arm/Group was 145 subjects (instead of the 154 randomized subjects who Started in Participant Flow) and the safety population for the Placebo Arm/Group was 135 subjects (instead of the 126 randomized subjects who Started in Participant Flow).
Nervous system disorders Burning Sensation	1.4% 2/145 • 1 year, 2 months Following randomization, 9 subjects were inaccurately dispensed Placebo instead of Natroba. Therefore, the safety population for the Natroba Arm/Group was 145 subjects (instead of the 154 randomized subjects who Started in Participant Flow) and the safety population for the Placebo Arm/Group was 135 subjects (instead of the 126 randomized subjects who Started in Participant Flow).	0.00% 0/135 • 1 year, 2 months Following randomization, 9 subjects were inaccurately dispensed Placebo instead of Natroba. Therefore, the safety population for the Natroba Arm/Group was 145 subjects (instead of the 154 randomized subjects who Started in Participant Flow) and the safety population for the Placebo Arm/Group was 135 subjects (instead of the 126 randomized subjects who Started in Participant Flow).
Skin and subcutaneous tissue disorders Erythema	0.00% 0/145 • 1 year, 2 months Following randomization, 9 subjects were inaccurately dispensed Placebo instead of Natroba. Therefore, the safety population for the Natroba Arm/Group was 145 subjects (instead of the 154 randomized subjects who Started in Participant Flow) and the safety population for the Placebo Arm/Group was 135 subjects (instead of the 126 randomized subjects who Started in Participant Flow).	0.74% 1/135 • 1 year, 2 months Following randomization, 9 subjects were inaccurately dispensed Placebo instead of Natroba. Therefore, the safety population for the Natroba Arm/Group was 145 subjects (instead of the 154 randomized subjects who Started in Participant Flow) and the safety population for the Placebo Arm/Group was 135 subjects (instead of the 126 randomized subjects who Started in Participant Flow).

Additional Information

Kerry W. Mettert, MBA, MT(ASCP)

ParaPRO, LLC

Phone: 317-810-6205

Email: [email protected]

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