Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies
Condition: Scabies
MeSH terms: Scabies
Intervention: spinosad topical suspension, 0.9%; Placebo
Intervention description: 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 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 291.0
Sex: All
Minimum age: 4 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All household members who have provided written informed consent and an authorization
             for disclosure of protected health information must meet all the following criteria:

               1. Male or female, age 4 years and upward.

               2. At least one household member must have active scabies infestation confirmed by
                  clinical signs and symptoms (evidence of burrows or presence of scabies
                  inflammatory/non-inflammatory lesions and pruritus) as well as by microscopic
                  examination of skin scraping, or dermatoscopy, to demonstrate the presence of
                  mites, eggs, and/or scybala. If dermatoscopy is used it should also confirm there
                  are burrows on the skin.

               3. Generally in good health based on medical history and clinical assessments.

               4. Normal-appearing skin in noninfested areas.

               5. No history of chronic or recurrent dermatologic disease.

               6. Willingness to comply with the study procedures including blood collections and
                  application of study treatment at home or in-clinic (PK subjects).

               7. Willing and able to practice an acceptable measure of contraception during the
                  study, if female of childbearing potential. Examples of acceptable contraceptive
                  methods include abstinence, intrauterine device (IUD) or double barrier method,
                  oral or injectable contraceptives (must have been using consistent systemic
                  contraceptives for at least 3 months prior to enrollment). If abstinent and
                  planning to become sexually active with a household member must agree to use a
                  double barrier method.

               8. Subject agrees to inform their sexual partners to seek an examination for scabies
                  and treatment if, and when, symptoms present.

               9. Household members must be 6 or fewer and all members must be willing to attend
                  clinic visits and be randomized to treatment (blinded, but same for all).

        Exclusion Criteria:

          -  All household members must be excluded if any of the following conditions are met:

               1. Household has greater than 6 residents.

               2. Has a household member(s) who is not willing or not eligible to enroll.

               3. Presence of scabies on the scalp.

               4. Presence of crusted scabies (Norwegian scabies).

               5. Allergies or intolerance to ingredients in the IPs.

               6. Current pregnancy (as assessed by urine pregnancy test) or currently nursing.

               7. The household has sexually active subjects who do not agree to restrict prolonged
                  skin to skin contact with non-household members during the trial period.

               8. Known renal or hepatic impairment.

               9. Treatment with scabicide within the prior 4 weeks.

              10. Immunodeficiency (including HIV infection) as reported in Medical History.

              11. Signs or symptoms of systemic infection.

              12. Administration of systemic therapy for infectious disease within the prior 2
                  weeks.

              13. Receipt of any IP within the prior 4 weeks.

              14. Any other conditions that, at the investigator's discretion, may interfere with
                  the study conduct, or which might confound the interpretation of the study
                  results, or which may put the subject at undue risk.

              15. Does not have a known household affiliation with their household members (stays
                  in one household inconsistently, i.e., sleeps at one place several nights and
                  then other places on other nights).

              16. Household member is unwilling to treat scabies.