ScabiesPhase 4NCT05310734
PK and Safety Study of Natroba Topical Suspension 0.9% in Subjects 1 Month to 3 Years 11 Months of Age With Scabies
A Phase 4 study testing Spinosad Topical in people with Scabies, run by Cipher Pharmaceuticals Inc. at 3 sites in United States.
Trial summary
A population of approximately 50 pediatric subjects will be enrolled to assess the PK of spinosad and benzyl alcohol for 3 hours following a single, full-body topical application (open label) on a single in-clinic visit (Day 1, or Day 2 if screening only on Day 1). Read more about this study
- Who is it for?
- Ages 1 month to 4 years
- Conditions the study is for
- Scabies
- What is being tested?
- Spinosad Topical
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Mar 2022to 31 Mar 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female, ages 1 month to 3 years and 11 months.
- 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 burrow ink test (BIT) to demonstrate the presence of burrowing mites.
- Generally, in good health based on medical history and clinical assessments.
- Normal-appearing skin in non-infested areas.
- No history of chronic or recurrent dermatologic disease.
- Willingness to comply with the study procedures including blood collections and application of study treatment in-clinic.
Who cannot join
- Presence of crusted scabies (Norwegian scabies).
- Allergies or intolerance to ingredients in the Investigational Product.
- Known renal or hepatic impairment.
- Treatment with scabicide within the prior 2 weeks.
- Immunodeficiency (including HIV infection) as reported in Medical History.
- Signs or symptoms of systemic infection.
Show all 12Show fewer
- Administration of systemic therapy for infectious disease within the prior 2 weeks.
- Receipt of any investigational product within the prior 4 weeks.
- Medications used for itching or other indication that contain benzyl alcohol or other alcohols within the past 7 days.
- Over-the-counter cortisone products within the past 7 days.
- Oral prescription medications and/or antibiotics within the past 7 days.
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Elixir Research Group
Houston, Texas, 77077
Favor Emesiani, 832-310-4750, f.emesiani@elixirrg.com
Anita Ehidiamen, 832-310-4750, a.jumai@elixirrg.com
- Recruiting
Velocity Clinical Research
Lafayette, Louisiana, 70508
Mary Long, 337-451-0663, mlong@velocityclinical.com
DeAnna Seamester, 337-451-0663, dseamester@velocityclinical.com
- Recruiting
L&C Professional Medical Research Institute
Miami, Florida, 33144
Maylen Perez, 305-269-1616, mperez@pmedresearch.com
Liagnys Garcia, 305-269-1616, lgarciarn@pmedresearch.com
About this study
Official title: A Single Treatment Pharmacokinetic and Safety Study of Natroba (Spinosad) Topical Suspension 0.9% w/w in Subjects 1 Month to 3 Years 11 Months of Age With an Active Scabies Infestation
A population of approximately 50 pediatric subjects will be enrolled to assess the PK of spinosad and benzyl alcohol for 3 hours following a single, full-body topical application (open label) on a single in-clinic visit (Day 1, or Day 2 if screening only on Day 1). There will be approximately 50 subjects ages 1 month to 3 years 11 months of age enrolled with the goal of completing approximately 16 subjects. With assistance from a caregiver, Natroba will be applied over the entire body from the neck down to the toes (including the soles of the feet) and to the hairline, temples, forehead and possibly the scalp (if a scabies infestation is present on the scalp). The open-label Investigational Product (IP) will remain on the skin for at least 6 hours before removing the IP by gentle washing. The subjects will stay in the clinic until the 3-hour procedures are completed. Blood draws will be taken at 0 hours just prior to treatment, and then at 0.5 and 3.0 hours post-treatment. Heel sticks are likely to be the mode of blood collection for children less than 2 years of age. A ±5-minute time window will be allowed for all post-treatment blood samples. Removal of IP can occur by the caregiver at home after it has been on the skin for at least 6 hours before bathing the child. Safety will be assessed with adverse events (AEs), general skin and eye irritation assessments, and pre-dose and pre-discharge laboratory evaluations. Following the sample collections subjects will be released from the clinic and directed to their primary care physician for follow-up. Subjects will be provided scabies medications upon discharge to dispense to family members. These include 5% Permethrin for those in the household that are less than 4 years of age and Natroba for those in the household 4 years of age and older. Subjects who terminate early will not be given these medications to dispense to family members.
Read the detailed description
A population of approximately 50 pediatric subjects will be enrolled to assess the PK of spinosad and benzyl alcohol for 3 hours following a single, full-body topical application (open label) on a single in-clinic visit (Day 1, or Day 2 if screening only on Day 1). There will be approximately 50 subjects ages 1 month to 3 years 11 months of age enrolled with the goal of completing approximately 16 subjects. With assistance from a caregiver, Natroba will be applied over the entire body from the neck down to the toes (including the soles of the feet) and to the hairline, temples, forehead and possibly the scalp (if a scabies infestation is present on the scalp). The open-label Investigational Product (IP) will remain on the skin for at least 6 hours before removing the IP by gentle washing. The subjects will stay in the clinic until the 3-hour procedures are completed. Blood draws will be taken at 0 hours just prior to treatment, and then at 0.5 and 3.0 hours post-treatment. Heel sticks are likely to be the mode of blood collection for children less than 2 years of age. A ±5-minute time window will be allowed for all post-treatment blood samples. Removal of IP can occur by the caregiver at home after it has been on the skin for at least 6 hours before bathing the child. Safety will be assessed with adverse events (AEs), general skin and eye irritation assessments, and pre-dose and pre-discharge laboratory evaluations. Following the sample collections subjects will be released from the clinic and directed to their primary care physician for follow-up. Subjects will be provided scabies medications upon discharge to dispense to family members. These include 5% Permethrin for those in the household that are less than 4 years of age and Natroba for those in the household 4 years of age and older. Subjects who terminate early will not be given these medications to dispense to family members.
Natroba (spinosad) Topical Suspension, 0.9% w/w applied by a parent/guardian in a single, full-body topical application from the neck down to the toes (including the soles of the feet) and to the hairline, temples, forehead and possibly the scalp (if a scabies infestation is present on the scalp).
A blood draw will be taken from subjects just before spinosad application (t=0) and then at 0.5 and3.0 hours. The following PK parameters will be calculated for spinosad (spinosyn A and spinosyn D) and benzyl alcohol in each subject: Cmax, Tmax, and Area Under the Curve (AUC) 0-12h.
Safety assessments include monitoring of AEs on study Day 1 or Day 2, general skin and eye irritation assessment on Day 1 or Day 2, laboratory assessments on Day 1 or Day 2, prior medications, and concomitant medications on Day 1 (and Day 2, if applicable). Smaller laboratory blood samples will be collected pre-dose and 12-hours post-dose prior to discharge.
Pharmacokinetic (PK) parameters will be calculated by using model independent methods. Standard statistical analyses will be done on these parameters for the purpose of interpretation of the data (Cmax, Tmax and Area Under the Curve (AUC) 0-3h and will be used to assess the absorption over 3 hours post-administration in 50 subjects (1 month - 3 years 11 months). The PK parameter estimates will be computed with noncompartmental methods for each subject. Individual elapsed sampling times (actual time) will be used in the PK analysis and parameters will be computed for each subject. Descriptive summaries of the plasma concentration levels for both spinosad (spinosyn A and spinosyn D) and benzyl alcohol observed at each nominal time point will be provided. Descriptive summaries of the PK parameter estimates will also be completed. Summary statistics for continuous variables will include number of non-missing observations, mean, standard deviation, coefficient of variation (CV%), median, minimum, and maximum, geometric mean and standard error of the geometric mean.
The safety endpoints include the evaluation of adverse events, general skin and eye irritation assessments, clinical laboratory assessments, and use of prior medications and concomitant medications. Additionally, the descriptive changes from baseline (pre-dose) to final assessment (pre-discharge) will be calculated for applicable parameters.
- Conditions
- Scabies
- Being tested
- Spinosad Topical
- Keywords
- Pharmacokinetics, PK, Pharmacokinetics and Safety Study of Spinosad, PK and Safety Study of Spinosad, Spinosad PK and Safety Study, Safety, Pharmacokinetic and Safety Study of Natroba, PK and Safety Study of Natroba, Natroba PK and Safety Study
- Medical subject headings
- Scabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinosad TopicalDrug
Also called Natroba, benzyl alcohol
A topical suspension indicated for the treatment of scabies is used for this PK and Safety Study
| Study group | Role | What they receive |
|---|---|---|
| PK and Safety | Experimental | A Single 6-hour Treatment, Pharmacokinetic and Safety Study of Natroba (spinosad) Topical Suspension 0.9% w/w in Subjects 1 Month to 3 Years 11 Months of Age with an Active Scabies Infestation. Receives: Drug: Spinosad Topical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax for Spinosyn A
Peak Plasma Concentration of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%
Measured: Blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.
Tmax for Spinosyn A
The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for Spinosyn A.
Measured: Blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.
Area Under the Curve (AUC) 0-3 for Spinosyn A
Area under the plasma concentration versus time curve Area Under the Curve (AUC) of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%.
Measured: Blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.
Cmax for Spinosyn D
Peak Plasma Concentration of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%
Measured: Blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.
Tmax for Spinosyn D
The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for Spinosyn D.
Measured: Blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.
Area Under the Curve (AUC) 0-3 for Spinosyn D
Area under the plasma concentration versus time curve Area Under the Curve (AUC) of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%.
Measured: Blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.
Cmax for Benzyl Alcohol
Peak Plasma Concentration of benzyl alcohol (above Limit of Quantitation (1.0 μg/mL) in Natroba (spinosad) Topical Suspension, 0.9%.
Measured: Blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.
Tmax for Benzyl Alcohol
The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for benzyl alcohol.
Measured: Blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.
Area Under the Curve (AUC) 0-3 for Benzyl Alcohol
Area under the plasma concentration versus time curve Area Under the Curve (AUC) of benzyl alcohol in Natroba (spinosad) Topical Suspension, 0.9%.
Measured: Blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.
Treatment Emergent Adverse Events
Treatment emergent AEs will be coded using MedDRA and summarized by System Organ Class and Preferred Term.
Measured: Through study completion, 3 hours
Change in General Skin Irritation
The skin assessment will include documentation of presence or absence of irritation.
Measured: Through study completion, 3 hours
Change in General Eye Irritation
The eye assessment will include documentation of presence or absence of irritation with a rating scale 0-3. 0 - no irritation, 1 - mild scleral, lid and/or lid injection with conjuctival erythema; 2 - moderate scleral and/or lid injection with conjunctival erythema; 3 - severe scleral and/or lid injection with conjunctival erythema and purulent drainage.
Measured: Through study completion, 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start4 Mar 2022
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScabiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A blood draw will be taken from subjects just before a full body spinosad application (t=0) and then at 0.5 and 3.0 hours. The following PK parameters will be calculated for spinosad (spinosyn A and spinosyn D) and benzyl alcohol in each subject: Cmax, Tmax, and Area Under the Curve (AUC) 0-3h. Safety assessments include monitoring of AEs, general skin and eye irritation, laboratory assessments, prior medications, and concomitant medications. Smaller laboratory blood samples will be collected pre-dose and 3-hours post-dose prior to discharge.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cipher Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Concentrics Research, IQVIA Pty Ltd, Medpace, Inc., Inotiv Laboratories, BioAgilytix
- Responsible party
- Sponsor
- Investigators
- Sharda Angl, Study director, Cipher Pharmaceuticals Inc.Julie Aker, MT(ASCP), Study chair, Concentrics ResearchWilliam Miller, MD, Principal investigator, Concentrics Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310734
- Sponsor's protocol ID
- SPN-110-21
- Status last verified
- Feb 2024
- First submitted
- 9 Mar 2022
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Treatment Pharmacokinetic and Safety Study of Natroba (Spinosad) Topical Suspension 0.9% w/w in Subjects 1 Month to 3 Years 11 Months of Age With an Active Scabies Infestation
- ClinicalTrials.gov ID
- NCT05310734
- Acronym / sponsor ID
- SPN-110-21
- Conditions
- Scabies
- Keywords
- Pharmacokinetics, PK, Pharmacokinetics and Safety Study of Spinosad, PK and Safety Study of Spinosad, Spinosad PK and Safety Study, Safety, Pharmacokinetic and Safety Study of Natroba, PK and Safety Study of Natroba
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cipher Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Collaborators
- Concentrics Research, IQVIA Pty Ltd, Medpace, Inc., Inotiv Laboratories, BioAgilytix
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A population of approximately 50 pediatric subjects will be enrolled to assess the PK of spinosad and benzyl alcohol for 3 hours following a single, full-body topical application (open label) on a single in-clinic visit (Day 1, or Day 2 if screening only on Day 1). There will be approximately 50 subjects ages 1 month to 3 years 11 months of age enrolled with the goal of completing approximately 16 subjects. With assistance from a caregiver, Natroba will be applied over the entire body from the neck down to the toes (including the soles of the feet) and to the hairline, temples, forehead and possibly the scalp (if a scabies infestation is present on the scalp). The open-label Investigational Product (IP) will remain on the skin for at least 6 hours before removing the IP by gentle washing. The subjects will stay in the clinic until the 3-hour procedures are completed. Blood draws will be taken at 0 hours just prior to treatment, and then at 0.5 and 3.0 hours post-treatment. Heel sticks are likely to be the mode of blood collection for children less than 2 years of age. A ±5-minute time window will be allowed for all post-treatment blood samples. Removal of IP can occur by the caregiver at home after it has been on the skin for at least 6 hours before bathing the child. Safety will be assessed with adverse events (AEs), general skin and eye irritation assessments, and pre-dose and pre-discharge laboratory evaluations. Following the sample collections subjects will be released from the clinic and directed to their primary care physician for follow-up. Subjects will be provided scabies medications upon discharge to dispense to family members. These include 5% Permethrin for those in the household that are less than 4 years of age and Natroba for those in the household 4 years of age and older. Subjects who terminate early will not be given these medications to dispense to family members.
Detailed description
A population of approximately 50 pediatric subjects will be enrolled to assess the PK of spinosad and benzyl alcohol for 3 hours following a single, full-body topical application (open label) on a single in-clinic visit (Day 1, or Day 2 if screening only on Day 1). There will be approximately 50 subjects ages 1 month to 3 years 11 months of age enrolled with the goal of completing approximately 16 subjects. With assistance from a caregiver, Natroba will be applied over the entire body from the neck down to the toes (including the soles of the feet) and to the hairline, temples, forehead and possibly the scalp (if a scabies infestation is present on the scalp). The open-label Investigational Product (IP) will remain on the skin for at least 6 hours before removing the IP by gentle washing. The subjects will stay in the clinic until the 3-hour procedures are completed. Blood draws will be taken at 0 hours just prior to treatment, and then at 0.5 and 3.0 hours post-treatment. Heel sticks are likely to be the mode of blood collection for children less than 2 years of age. A ±5-minute time window will be allowed for all post-treatment blood samples. Removal of IP can occur by the caregiver at home after it has been on the skin for at least 6 hours before bathing the child. Safety will be assessed with adverse events (AEs), general skin and eye irritation assessments, and pre-dose and pre-discharge laboratory evaluations. Following the sample collections subjects will be released from the clinic and directed to their primary care physician for follow-up. Subjects will be provided scabies medications upon discharge to dispense to family members. These include 5% Permethrin for those in the household that are less than 4 years of age and Natroba for those in the household 4 years of age and older. Subjects who terminate early will not be given these medications to dispense to family members.
Natroba (spinosad) Topical Suspension, 0.9% w/w applied by a parent/guardian in a single, full-body topical application from the neck down to the toes (including the soles of the feet) and to the hairline, temples, forehead and possibly the scalp (if a scabies infestation is present on the scalp).
A blood draw will be taken from subjects just before spinosad application (t=0) and then at 0.5 and3.0 hours. The following PK parameters will be calculated for spinosad (spinosyn A and spinosyn D) and benzyl alcohol in each subject: Cmax, Tmax, and Area Under the Curve (AUC) 0-12h.
Safety assessments include monitoring of AEs on study Day 1 or Day 2, general skin and eye irritation assessment on Day 1 or Day 2, laboratory assessments on Day 1 or Day 2, prior medications, and concomitant medications on Day 1 (and Day 2, if applicable). Smaller laboratory blood samples will be collected pre-dose and 12-hours post-dose prior to discharge.
Pharmacokinetic (PK) parameters will be calculated by using model independent methods. Standard statistical analyses will be done on these parameters for the purpose of interpretation of the data (Cmax, Tmax and Area Under the Curve (AUC) 0-3h and will be used to assess the absorption over 3 hours post-administration in 50 subjects (1 month - 3 years 11 months). The PK parameter estimates will be computed with noncompartmental methods for each subject. Individual elapsed sampling times (actual time) will be used in the PK analysis and parameters will be computed for each subject. Descriptive summaries of the plasma concentration levels for both spinosad (spinosyn A and spinosyn D) and benzyl alcohol observed at each nominal time point will be provided. Descriptive summaries of the PK parameter estimates will also be completed. Summary statistics for continuous variables will include number of non-missing observations, mean, standard deviation, coefficient of variation (CV%), median, minimum, and maximum, geometric mean and standard error of the geometric mean.
The safety endpoints include the evaluation of adverse events, general skin and eye irritation assessments, clinical laboratory assessments, and use of prior medications and concomitant medications. Additionally, the descriptive changes from baseline (pre-dose) to final assessment (pre-discharge) will be calculated for applicable parameters.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A blood draw will be taken from subjects just before a full body spinosad application (t=0) and then at 0.5 and 3.0 hours. The following PK parameters will be calculated for spinosad (spinosyn A and spinosyn D) and benzyl alcohol in each subject: Cmax, Tmax, and Area Under the Curve (AUC) 0-3h. Safety assessments include monitoring of AEs, general skin and eye irritation, laboratory assessments, prior medications, and concomitant medications. Smaller laboratory blood samples will be collected pre-dose and 3-hours post-dose prior to discharge.
| Arm | Type | Receives |
|---|---|---|
| PK and Safety | Experimental | Drug: Spinosad TopicalA Single 6-hour Treatment, Pharmacokinetic and Safety Study of Natroba (spinosad) Topical Suspension 0.9% w/w in Subjects 1 Month to 3 Years 11 Months of Age with an Active Scabies Infestation. |
Who may qualify
- Ages
- 1 month to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male or female, ages 1 month to 3 years and 11 months.
- 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 burrow ink test (BIT) to demonstrate the presence of burrowing mites.
- Generally, in good health based on medical history and clinical assessments.
- Normal-appearing skin in non-infested areas.
- No history of chronic or recurrent dermatologic disease.
Key exclusion criteria (12 listed)
- Presence of crusted scabies (Norwegian scabies).
- Allergies or intolerance to ingredients in the Investigational Product.
- Known renal or hepatic impairment.
- Treatment with scabicide within the prior 2 weeks.
- Immunodeficiency (including HIV infection) as reported in Medical History.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinosad TopicalAlso: Natroba, benzyl alcoholA topical suspension indicated for the treatment of scabies is used for this PK and Safety Study | Drug | PK and Safety |
Primary outcome
Cmax for Spinosyn A
Time frame: Blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.
Peak Plasma Concentration of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%
Tmax for Spinosyn A
Time frame: Blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.
The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for Spinosyn A.
Area Under the Curve (AUC) 0-3 for Spinosyn A
Time frame: Blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.
Area under the plasma concentration versus time curve Area Under the Curve (AUC) of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%.
Cmax for Spinosyn D
Time frame: Blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.
Peak Plasma Concentration of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%
Tmax for Spinosyn D
Time frame: Blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.
The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for Spinosyn D.
Area Under the Curve (AUC) 0-3 for Spinosyn D
Time frame: Blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.
Area under the plasma concentration versus time curve Area Under the Curve (AUC) of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%.
Cmax for Benzyl Alcohol
Time frame: Blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.
Peak Plasma Concentration of benzyl alcohol (above Limit of Quantitation (1.0 μg/mL) in Natroba (spinosad) Topical Suspension, 0.9%.
Tmax for Benzyl Alcohol
Time frame: Blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.
The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for benzyl alcohol.
Area Under the Curve (AUC) 0-3 for Benzyl Alcohol
Time frame: Blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.
Area under the plasma concentration versus time curve Area Under the Curve (AUC) of benzyl alcohol in Natroba (spinosad) Topical Suspension, 0.9%.
Treatment Emergent Adverse Events
Time frame: Through study completion, 3 hours
Treatment emergent AEs will be coded using MedDRA and summarized by System Organ Class and Preferred Term.
Change in General Skin Irritation
Time frame: Through study completion, 3 hours
The skin assessment will include documentation of presence or absence of irritation.
Change in General Eye Irritation
Time frame: Through study completion, 3 hours
The eye assessment will include documentation of presence or absence of irritation with a rating scale 0-3. 0 - no irritation, 1 - mild scleral, lid and/or lid injection with conjuctival erythema; 2 - moderate scleral and/or lid injection with conjunctival erythema; 3 - severe scleral and/or lid injection with conjunctival erythema and purulent drainage.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharda Angl study director
Cipher Pharmaceuticals Inc.
Julie Aker, MT(ASCP) study chair
Concentrics Research
William Miller, MD principal investigator
Concentrics Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spinosad Topical in people with Scabies, run by Cipher Pharmaceuticals Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sharda Angl (905-602-5840 ext. 267, sangl@cipherpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax for Spinosyn A (time frame: Blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.