Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies
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|ClinicalTrials.gov Identifier: NCT02485704|
Recruitment Status : Completed
First Posted : June 30, 2015
Results First Posted : January 16, 2019
Last Update Posted : January 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Scabies||Drug: spinosad topical suspension, 0.9% Other: Placebo||Phase 3|
This is a double blind, two-arm, 28-day, placebo-controlled study with approximately 120 infested "index" subjects randomized 1:1 to Natroba™ or Placebo. All members of a household (no more than 6 individuals) with a suspected "index" subject must be screened at the first visit. In this study, "index" subjects are defined as the youngest infested household member (≥4 years). If the members have an active scabies infestation and meet all other criteria, they must agree to participate in the study. Household members who do not present with scabies at the screening visit must also agree to apply the same blinded investigational product (IP) as household members who present with scabies. All infested household members must agree to participate in the study or none will be enrolled. Screening procedures include informed consent, medication and medical history, urine pregnancy test for females of childbearing potential, scabies assessment (visual evidence of burrows, inflammatory/non-inflammatory lesions and pruritus), microscopic examination of skin scraping, or dermatoscopy, to demonstrate the presence of mites, eggs, and/or scybala (dermatoscopy must confirm burrows), vital signs, general skin and eye assessment, randomization, and IP dispensing and instruction.
After screening on Day 1, all randomized subjects will be dispensed IP (Natroba™ or Placebo) to apply at home later the same day as a single treatment over the entire body from the neck down to the toes (including the soles of the feet) and to the scalp (if balding) or hairline, temples and forehead on the same day. Subjects less than 12 years of age should be assisted with administration by a parent, guardian or caregiver. Subjects will rub the treatment into the skin followed by a 10-minute wait period before getting dressed. Showering or bathing must not occur earlier than 6 hours after treatment and no later than at least 1 hour prior to Day 2 visit.
On Day 2 (Visit 2), all household members will return for general skin and eye assessments of possible irritation, and to confirm that all IP was left on for a minimum of 6 hours before bathing or showering. If a subject reports an adverse event assessed as related by the PI on Day 2 (Visit 2) then a follow-up visit with the investigator must be scheduled within 7 days of visit. All household members will receive a well-being phone call on Day 14 to continue to emphasize instructions to prevent re-infestation, determine if any concomitant medications have been used, and check for adverse events. If a subject reports an adverse event assessed as related by the PI on the Day 14 well-being phone call, then a follow-up visit with the investigator must be scheduled within 7 days of phone call.
On Day 28 (Visit 3), all household members will return to the clinic for safety and efficacy assessments. The primary endpoint of complete cure will be assessed in the "index" subject and any infested household members. If the infested subject is completely cured at Day 28, he or she will have completed the study and termination procedures will be conducted. If the subject is not completely cured at Day 28 (with Natroba™ or Placebo), the subject will receive 5% Permethrin and will be directed to their primary care physician for follow-up.
Safety assessments will be made for all household members and will include monitoring of adverse events (AEs) throughout the study, vital signs recording (Days 1 and 28), clinical laboratory analyses (Days 1 and 28), and general skin and eye irritation assessments (Days 1, 2, and 28). The Day 28 procedures will also be completed for early termination (ET) except subjects will not receive rescue Permethrin but will be directed to follow-up with their primary care physician.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Randomized, Double Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Natroba™ (Spinosad) for the Treatment of Scabies|
|Actual Study Start Date :||May 10, 2017|
|Actual Primary Completion Date :||August 3, 2018|
|Actual Study Completion Date :||August 3, 2018|
Experimental: 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
Drug: 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.
Other Name: Natroba (spinosad) Topical Suspension, 0.9%
Placebo Comparator: 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 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 [ Time Frame: 28 days after treatment ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485704
|United States, California|
|Saint Joseph's Clinical Research|
|Anaheim, California, United States, 92804|
|Long Beach Clinical Trial Services|
|Long Beach, California, United States, 90806|
|United States, Florida|
|The Chappel Group Research|
|Kissimmee, Florida, United States, 34744|
|United States, Pennsylvania|
|DermDox Centers for Dermatology|
|Hazleton, Pennsylvania, United States, 18201|
|Paddington Testing Company|
|Philadelphia, Pennsylvania, United States, 19103|
|United States, Texas|
|West Houston Clinical Research Service|
|Houston, Texas, United States, 77055|
|Discovery Clinical Trials|
|McAllen, Texas, United States, 78503|
|Study Director:||Kerry W Mettert, MBA||ParaPRO LLC|