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

NCT02485717 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: SPN-303-15
• Study Type: interventional
• Target: 291
• Locations: 1 country
• Sites: 5

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.

Conditions

Scabies

Outcome Measures

Primary Outcomes (1)

• Number of Index Subjects Completely Cured of Scabies After a Single 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.

  28 days after treatment

Secondary Outcomes (6)

• 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).

  12 Hours

• 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).

  12 Hours

• 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).

  12 Hours

• 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).

  12 Hours

• 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).

  12 Hours

Study Arms (2)

Natroba (spinosad)

EXPERIMENTAL

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%

Placebo

PLACEBO COMPARATOR

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

Interventions

spinosad topical suspension, 0.9% DRUG

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.

Also known as: Natroba (spinosad) Topical Suspension, 0.9%

Natroba (spinosad)

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All household members who have provided written informed consent and an authorization for disclosure of protected health information must meet all the following criteria:
• Male or female, age 4 years and upward.
• 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.
• Generally in good health based on medical history and clinical assessments.
• Normal-appearing skin in noninfested areas.
• No history of chronic or recurrent dermatologic disease.
• Willingness to comply with the study procedures including blood collections and application of study treatment at home or in-clinic (PK subjects).
• 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.
• Subject agrees to inform their sexual partners to seek an examination for scabies and treatment if, and when, symptoms present.
• 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).

You may not qualify if:

• All household members must be excluded if any of the following conditions are met:
• Household has greater than 6 residents.
• Has a household member(s) who is not willing or not eligible to enroll.
• Presence of scabies on the scalp.
• Presence of crusted scabies (Norwegian scabies).
• Allergies or intolerance to ingredients in the IPs.
• Current pregnancy (as assessed by urine pregnancy test) or currently nursing.
• 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.
• Known renal or hepatic impairment.
• Treatment with scabicide within the prior 4 weeks.
• Immunodeficiency (including HIV infection) as reported in Medical History.
• Signs or symptoms of systemic infection.
• Administration of systemic therapy for infectious disease within the prior 2 weeks.
• Receipt of any IP within the prior 4 weeks.
• 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.

Sponsors & Collaborators

• ParaPRO LLC: lead
• Concentrics Research: collaborator

Study Sites (5)

Elk Grove Clinical Research

Elk Grove, California, 95758, United States

Location

The Chappel Group Research

Kissimmee, Florida, 34744, United States

Location

San Marcus Research

Miami, Florida, 33015, United States

Location

L&C Professional Medical Research Institute

Miami, Florida, 33144, United States

Location

LSRN Research

West Palm Beach, Florida, 33407, United States

Location

MeSH Terms

Conditions

Scabies

Interventions

spinosad; Suspensions

Condition Hierarchy (Ancestors)

Mite Infestations; Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Kerry W. Mettert, MBA, MT(ASCP)
• Organization: ParaPRO, LLC

kerrym@parapro.com

317-810-6205

Study Officials

• Kerry W Mettert, MBA

  ParaPRO LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2015
• First Posted: June 30, 2015
• Study Start: May 2, 2017
• Primary Completion: June 25, 2018
• Study Completion: June 25, 2018
• Last Updated: May 19, 2021
• Results First Posted: January 16, 2019

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)