Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies
A Phase 3, Randomized, Double Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Natroba™ (Spinosad) for the Treatment of Scabies
1 other identifier
interventional
280
1 country
7
Brief Summary
To assess the safety and efficacy of Natroba (spinosad) topical suspension versus placebo for the complete cure of scabies after a single treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2017
Shorter than P25 for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2015
CompletedFirst Posted
Study publicly available on registry
June 30, 2015
CompletedStudy Start
First participant enrolled
May 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 3, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 3, 2018
CompletedResults Posted
Study results publicly available
January 16, 2019
CompletedMay 21, 2021
April 1, 2021
1.2 years
June 19, 2015
November 30, 2018
April 30, 2021
Conditions
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
Study Arms (2)
Natroba (spinosad)
EXPERIMENTALspinosad 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
Placebo
PLACEBO COMPARATORplacebo 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.
Interventions
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.
Eligibility Criteria
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 application of study treatment at home as instructed.
- 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), double barrier method, oral or implantable or injectable contraceptives. Must have been using systemic (oral, injectable, or implantable) contraceptives for at least 3 months. If abstinent and planning to become sexually active 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 by the subject in Medical History.
- Signs or symptoms of systemic infection.
- Administration of any systemic therapy for infectious disease within the prior 2 weeks.
- Receipt of any other investigational product (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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ParaPRO LLClead
- Concentrics Researchcollaborator
Study Sites (7)
Saint Joseph's Clinical Research
Anaheim, California, 92804, United States
Long Beach Clinical Trial Services
Long Beach, California, 90806, United States
The Chappel Group Research
Kissimmee, Florida, 34744, United States
DermDox Centers for Dermatology
Hazleton, Pennsylvania, 18201, United States
Paddington Testing Company
Philadelphia, Pennsylvania, 19103, United States
West Houston Clinical Research Service
Houston, Texas, 77055, United States
Discovery Clinical Trials
McAllen, Texas, 78503, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kerry W. Mettert, MBA, MT(ASCP)
- Organization
- ParaPRO, LLC
Study Officials
- STUDY DIRECTOR
Kerry W Mettert, MBA
ParaPRO LLC
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 10, 2017
Primary Completion
August 3, 2018
Study Completion
August 3, 2018
Last Updated
May 21, 2021
Results First Posted
January 16, 2019
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share