Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02485717 |
Recruitment Status :
Completed
First Posted : June 30, 2015
Results First Posted : January 16, 2019
Last Update Posted : May 19, 2021
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Scabies | Drug: spinosad topical suspension, 0.9% Other: Placebo | Phase 3 |

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 |

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. |
- 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.
- 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 ]
- 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 ]
- 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 ]
- 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.
- 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.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 4 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
- 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).
Exclusion Criteria:
-
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.
- 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).
- Household member is unwilling to treat scabies.

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
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 |
Study Director: | Kerry W Mettert, MBA | ParaPRO LLC |
Documents provided by ParaPRO LLC:
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Scabies Mite Infestations Ectoparasitic Infestations Skin Diseases, Parasitic |
Parasitic Diseases Infections Skin Diseases, Infectious Skin Diseases |