Clinical Trial: Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 3, Randomized, Double Blind, Placebo-Controlled Study to Assess the Safety, Efficacy and Pharmacokinetics of Natroba™ (Spinosad) for the Treatment of Scabies

Brief Summary: To assess the safety and efficacy of Natroba (spinosad) topical suspension versus placebo for the clinical cure of scabies after a single treatment. The trial will also assess the pharmacokinetics (PK) of spinosad and benzyl alcohol following a single dose of Natroba™ in pediatric subjects 4-16 years of age. These subjects will be a separate population of pediatric subjects.

Detailed Summary:

The primary study 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 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, CBC and serum chemistry, and IP dispensing and instruction.

After screening on Day 1, all randomized subjects in the primary population 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 gett
Sponsor: ParaPRO LLC

Current Primary Outcome: 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 demonstration of clinical cure (all signs and symptoms have completely resolved, including burrows, inflammatory/non-inflammatory lesions and pruritis) and microscopic or dermatoscopic cure demonstrating the absence of mites, eggs, and/or scybala, and negative dermatoscopy for burrows.


Original Primary Outcome:

  • Number of Participants Clinically Cured of Scabies After a Single Treatment [ Time Frame: 14 days after treatment ]
    A body diagram will be used to document the number of lesions on the initial visit to establish a baseline. 14 days after treatment an evaluation of of the lesions will be made. Changes from baseline will be assessed. Improvement will ge graded as follows: Mild = < 50% reduction in the number of lesions; Moderate = > or = 50% reduction in number of lesions; Good = complete clearance of lesions. Clinical cure - grades of moderate or good plus no new lesions. Failure - reduction in lesions counts assessed with a grade of mild or appearance of new lesions. Within-treatment analysis of changes from baseline will be conducted at the post-treatment time point utilizing Wilcoxon's Signed Rank Test. The frequency of subject improvement within-treatment will be analyzed using Chi-squared statistics.
  • Number of Participants with Adverse Events [ Time Frame: From point of treatment through clinical cure at Day 14 or through the end of the study at Day 28 ]


Current Secondary Outcome: Assessing the PK parameters (Cmax, Tmax and AUC 0-12h) of spinosad (Spinosyn A and Spinosyn D) and benzyl alcohol [ Time Frame: 12 Hours ]

The secondary efficacy assessment includes assessing the PK parameters (Cmax, Tmax and AUC 0-12h) of spinosad (Spinosyn A and Spinosyn D) and benzyl alcohol pre-dose and during 12 hours post-dose of Natroba™ in pediatric subjects (ages 4-16 years).


Original Secondary Outcome: Number of Subjects Clinically Cured of Scabies with Open-Label Product Who Demonstrated Treatment Failure with First Blinded Application of Spinosad or Placebo [ Time Frame: 14 days after treatment. ]

Efficacy of open-label Natroba (spinosad) for clinical cure of subjects who demonstrated treatment failure after the blinded first application of spinosad or placebo. A body diagram will be used to document the number of lesions on the 14-day visit to establish a baseline. 14 days after treatment an evaluation of of the lesions will be made. Changes from baseline will be assessed. Improvement will ge graded as follows: Mild = < 50% reduction in the number of lesions; Moderate = > or = 50% reduction in number of lesions; Good = complete clearance of lesions. Clinical cure - grades of moderate or good plus no new lesions. Failure - reduction in lesions counts assessed with a grade of mild or appearance of new lesions.The between-treatment analysis of changes from baseline will be conducted utilizing Wilcoxon's Rank Sum Test. The frequency of subject improvement between treatments wil be analyzed utilizing Chi-squared statistics.


Information By: ParaPRO LLC

Dates:
Date Received: June 19, 2015
Date Started: May 2, 2017
Date Completion: April 2018
Last Updated: May 18, 2017
Last Verified: May 2017