Natroba Topical Suspension for Scabies

Recruiting at 7 trial locations

Overseen By Sharda Angl

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Cipher Pharmaceuticals Inc.

Must not be taking: Scabicides, Cortisone, Antibiotics, others

Disqualifiers: Crusted scabies, Allergies, Immunodeficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study how Natroba Topical Suspension 0.9% affects young children with scabies, a skin condition caused by tiny mites. Researchers seek to understand how the medicine is absorbed into the body and assess its safety after skin application. Children with an active scabies infestation who are generally healthy may qualify for this study. Participants will receive the treatment in a clinic and remain there for a few hours for observation, with follow-up at home. As a Phase 4 trial, this research helps determine how the already FDA-approved and effective treatment benefits a broader range of patients.

Do I have to stop taking my current medications for the trial?

Yes, participants must stop taking certain medications before joining the trial. Specifically, you cannot have used scabicide in the past 2 weeks, medications containing benzyl alcohol or other alcohols, over-the-counter cortisone products, or oral prescription medications and antibiotics in the past 7 days.

What is the safety track record for Natroba Topical Suspension?

Research shows that the safety of Natroba Topical Suspension 0.9% for treating scabies in children under 4 years old remains unknown. However, Natroba has been proven safe for treating head lice in children as young as 6 months. This suggests it might be well-tolerated in young children, but it's important to remember that scabies and head lice are different conditions.

The treatment involves applying the suspension to the skin and leaving it on for a specified time. Safety checks include monitoring for skin and eye irritation and observing any side effects. While the treatment is generally safe for head lice, parents should be aware that its safety for scabies in very young children is still under investigation. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Natroba Topical Suspension 0.9% is unique because it uses spinosad, a naturally derived insecticide, as its active ingredient to target scabies mites. Unlike traditional treatments for scabies, such as permethrin cream or oral ivermectin, Natroba is applied topically and requires just a single 6-hour application, which can simplify treatment and increase patient compliance. Researchers are excited about this treatment because it offers a potentially faster and easier option to manage scabies infestations, especially in young children, without the need for repeated applications.

What evidence suggests that Natroba Topical Suspension might be an effective treatment for scabies?

Research has shown that Natroba Topical Suspension 0.9% effectively treats scabies in individuals aged 4 and older. Studies have found that spinosad, the main ingredient, is more effective than a non-medicated cream in these patients. This trial aims to assess the safety and effectiveness of Natroba for children under 4 years old. Since the treatment has already proven safe and effective for older children and adults, it may also work well for younger children. ^{6 7 8 9 10}

Who Is on the Research Team?

Sharda Angl

Principal Investigator

Cipher Pharmaceuticals Inc.

Julie Aker, MT(ASCP)

Principal Investigator

Concentrics Research

William Miller, MD

Principal Investigator

Concentrics Research

Are You a Good Fit for This Trial?

This trial is for children aged 1 month to under 4 years with active scabies, confirmed by clinical signs and microscopic examination. They should be in good health overall, have normal skin in non-infested areas, no chronic skin diseases, and willing to undergo study procedures like blood collections. Children who've used certain medications or treatments recently or have systemic infections or immunodeficiency are excluded.

Inclusion Criteria

I have scabies confirmed by symptoms and a positive burrow ink test.

My skin looks normal in areas not affected by the condition.

I am between 1 month and 3 years old.

Exclusion Criteria

I have used a scabicide treatment in the last 2 weeks.

I haven't used over-the-counter cortisone products in the last week.

You have a weak immune system, including HIV infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

A single, full-body topical application of Natroba (spinosad) Topical Suspension 0.9% is applied, followed by pharmacokinetic assessments

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, and directed to their primary care physician for follow-up

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Natroba Topical Suspension 0.9%

Trial Overview The trial tests Natroba Topical Suspension on young children with scabies. It involves a single full-body application of the medication at a clinic visit, followed by monitoring for three hours and blood samples taken before treatment and after half an hour and three hours post-treatment.

How Is the Trial Designed?

Group I: PK and Safety Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Cipher Pharmaceuticals Inc.

Lead Sponsor

Trials

4

Recruited

1,100+

ParaPRO LLC

Lead Sponsor

Trials

12

Recruited

2,000+

STATKING Clinical Services

Collaborator

Trials

2

Recruited

60+

MicroConstants, Inc.

Collaborator

Trials

1

Recruited

50+

Concentrics Research

Collaborator

Trials

4

Recruited

1,800+

Iqvia Pty Ltd

Industry Sponsor

Trials

120

Recruited

177,000+

Ari Bousbib

Iqvia Pty Ltd

Chief Executive Officer since 2016

MBA from Columbia University, Master of Science in Mathematics and Mechanical Engineering from Ecole Superieure des Travaux Publics, Paris

Jeffrey Spaeder

Iqvia Pty Ltd

Chief Medical Officer

MD

Medpace, Inc.

Industry Sponsor

Trials

98

Recruited

30,400+

Dr. August J. Troendle

Medpace, Inc.

Chief Executive Officer since 1992

MD from the University of Maryland, School of Medicine; MBA from Boston University

Dr. Reinilde Heyrman

Medpace, Inc.

Chief Medical Officer since 2017

MD

Inotiv Laboratories

Collaborator

Trials

1

Recruited

50+

BioAgilytix

Collaborator

Trials

1

Recruited

50+

Published Research Related to This Trial

In a study of 170 infants and children under 15 kg treated with oral ivermectin for scabies, only 4% experienced mild adverse events, indicating that ivermectin is safe for this age group.

Ivermectin was effective in achieving healing in 85% of patients, with higher efficacy associated with doses greater than 200 μg/kg and a dosing interval of less than 10 days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ivermectin safety in infants and children under 15 kg treated for scabies: a multicentric observational study. Levy, M., Martin, L., Bursztejn, AC., et al.[2022]

In a study involving 30 patients with scabies who had not responded to previous treatments, Metrifonate was administered at a dose of 10 mg/kg for two consecutive days each week, resulting in a high cure rate of 29 out of 30 patients.

While four patients experienced temporary side effects like nausea and vomiting, these were not severe, indicating that Metrifonate is generally safe and effective for treating scabies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of drug resistant scabies]. Ganzález Barranco, D., Manuel Trujillo V, V., Salazar Mallén, M., et al.[2013]

Tenutex® is recommended as a second-line treatment for patients with scabies if the initial treatment with 5% permethrin is unsuccessful.

The failure of 5% permethrin may be attributed to tolerance or resistance developed by scabies mites, highlighting the need for alternative therapies like Tenutex®.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eleven Danish patients diagnosed with Scabies and treated with Tenutex&#174;. Soerensen, CAS., Pallesen, KAU., Munk, NT., et al.[2021]

In a study of 40 patients treated for scabies with a 10% thiabendazole suspension, 80% experienced satisfactory results after just one treatment course.

Only 15% of patients needed a second treatment, and 5% required additional intralesional injections for persistent nodules, indicating that while thiabendazole is generally effective, some cases may need further intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topically applied thiabendazole in the treatment of scabies. Hernández-Pérez, E.[2019]

A novel whole-body bathing (WBB) method using ivermectin (IVM) showed a 71.4% cure rate for scabies in a trial with seven elderly patients, with all patients cured by day 29.

The treatment was found to be safe, as no significant adverse events occurred, and IVM levels in the blood were undetectable after bathing, indicating low internal exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case series of elderly patients with scabies topically applied with ivermectin via whole-body bathing. Komoda, M., Miyajima, A., Koshino, M., et al.[2022]

Permethrin is considered the most effective topical treatment for scabies, with minimal microbial resistance and limited toxicity, primarily causing occasional contact dermatitis.

Oral ivermectin is also highly effective for treating scabies, eliminating concerns about proper application, though it is currently not available in the US for this use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A risk-benefit assessment of agents used in the treatment of scabies. Elgart, ML.[2018]

Scabies is highly contagious and poses a significant health risk in nursing homes and hospitals, particularly for elderly and immunocompromised individuals, leading to severe itching and skin lesions.

Effective treatment and control of scabies outbreaks require coordinated efforts, including treating all exposed individuals, using scabicides like ivermectin for those with crusted scabies, and implementing strict hygiene and surveillance measures to prevent recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlling scabies in institutional settings: a review of medications, treatment models, and implementation. Scheinfeld, N.[2018]

The Japanese Dermatological Association emphasizes the importance of proper diagnosis for scabies, which includes assessing clinical symptoms, detecting the mite Sarcoptes scabiei, and considering epidemiological factors, with confirmation through microscopy or dermoscopy.

Oral ivermectin is an effective treatment for scabies, requiring a single dose of about 200 microg/kg, and may need a second dose if new lesions appear; however, there is a need for more safe and effective topical treatments to be approved for use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guideline for the diagnosis and treatment of scabies in Japan (second edition). Ishii, N.[2008]

Ivermectin achieved a 100% cure rate for scabies after two weeks, making it the most effective treatment in the study of 103 participants, while permethrin showed a significant reduction in itching after one week but had a lower overall cure rate at that time.

Benzyl benzoate and ivermectin were found to be the most cost-effective treatment regimens, with benzyl benzoate recommended as the first-line treatment followed by ivermectin for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of safety, efficacy, and cost effectiveness of benzyl benzoate, permethrin, and ivermectin in patients of scabies. Bachewar, NP., Thawani, VR., Mali, SN., et al.[2021]

Citations

1. natroba.com natroba.com/scabies/efficacy/

Natroba™ Scabies Efficacy Natroba™ offers substantiated efficacy in treating adult and pediatric (4 years of age and older) scabies infestations. See the efficacy data. Results from two ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34391812/

Spinosad at 0.9% in the treatment of scabies: Efficacy ... Conclusions: Spinosad at 0.9% performed better than vehicle in the treatment of scabies in these studies of subjects of 4 years of age or older ...

3. natroba.com natroba.com/scabies/jaad-clinical-study/

Spinosad 0.9% in the Treatment of Scabies [Double-Blind ... The safety and effectiveness of Natroba™ Topical Suspension have not been established in pediatric patients less than 4 years of age with scabies infestation.

4. fda.gov fda.gov/media/181817/download

Natroba Pediatric Postmarketing Safety Review Scabies Infestation. The safety and effectiveness of NATROBA for the topical treatment of scabies infestation have been established in ...

5. jaad.org jaad.org/article/S0190-9622(21)02290-8/fulltext

Spinosad at 0.9% in the treatment of scabies: Efficacy ... Spinosad at 0.9% performed better than vehicle in the treatment of scabies in these studies of subjects of 4 years of age or older following 1 application of ...

6. natroba.com natroba.com/scabies/safety/

Safety of Natroba™ for Scabies The safety and effectiveness of Natroba™ Topical Suspension have not been established in pediatric patients less than 4 years of age with scabies infestation.

7. natroba.com natroba.com/scabies/

Natroba™ (spinosad) & Scabies The safety and effectiveness of Natroba™ Topical Suspension have not been established in pediatric patients less than 4 years of age with scabies infestation.

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2021/022408s010lbl.pdf

NATROBA (spinosad) - accessdata.fda.gov The safety and effectiveness of NATROBA for the topical treatment of head lice infestation have been established in pediatric patients 6 months of age and older ...

9. mayoclinic.org mayoclinic.org/drugs-supplements/spinosad-topical-application-route/description/drg-20074722

Spinosad (topical application route) - Side effects & dosage Safety and efficacy of spinosad topical to treat scabies have not been established in children younger than 4 years of age. Use is not ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT05310734?term=BENZYL%20ALCOHOL&rank=3

PK and Safety Study of Natroba Topical Suspension 0.9% ... Safety will be assessed with adverse events (AEs), general skin and eye irritation assessments, and pre-dose and pre-discharge laboratory evaluations. Following ...