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Trial record 1 of 1 for:    NCT02485717
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Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies

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ClinicalTrials.gov Identifier: NCT02485717
Recruitment Status : Completed
First Posted : June 30, 2015
Results First Posted : January 16, 2019
Last Update Posted : May 19, 2021
Sponsor:
Collaborator:
Concentrics Research
Information provided by (Responsible Party):
ParaPRO LLC

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.

Condition or disease Intervention/treatment Phase
Scabies Drug: spinosad topical suspension, 0.9% Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 291 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 2, 2017
Actual Primary Completion Date : June 25, 2018
Actual Study Completion Date : June 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scabies
Drug Information available for: Spinosad

Arm Intervention/treatment
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. 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.
Other: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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). [ Time Frame: 12 Hours ]
  2. 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). [ Time Frame: 12 Hours ]
  3. 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). [ Time Frame: 12 Hours ]
  4. 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). [ Time Frame: 12 Hours ]
    Note: 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.

  5. 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). [ Time Frame: 12 Hours ]
    Note: 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.

  6. 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). [ Time Frame: 12 Hours ]
    Note: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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): NCT02485717


Locations
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United States, California
Elk Grove Clinical Research
Elk Grove, California, United States, 95758
United States, Florida
The Chappel Group Research
Kissimmee, Florida, United States, 34744
San Marcus Research
Miami, Florida, United States, 33015
L&C Professional Medical Research Institute
Miami, Florida, United States, 33144
LSRN Research
West Palm Beach, Florida, United States, 33407
Sponsors and Collaborators
ParaPRO LLC
Concentrics Research
Investigators
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Study Director: Kerry W Mettert, MBA ParaPRO LLC
  Study Documents (Full-Text)

Documents provided by ParaPRO LLC:
Study Protocol  [PDF] March 23, 2018
Statistical Analysis Plan  [PDF] August 24, 2018

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Responsible Party: ParaPRO LLC
ClinicalTrials.gov Identifier: NCT02485717    
Other Study ID Numbers: SPN-303-15
First Posted: June 30, 2015    Key Record Dates
Results First Posted: January 16, 2019
Last Update Posted: May 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Scabies
Mite Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
Skin Diseases, Infectious
Skin Diseases