Natroba Topical Suspension for Scabies

Recruiting in Philadelphia (>99 mi)

+7 other 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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the drug Natroba Topical Suspension 0.9% for treating scabies?

While there is no direct data on Natroba Topical Suspension 0.9% for scabies, similar topical treatments like thiabendazole and ivermectin have shown effectiveness. Thiabendazole had an 80% success rate in treating scabies, and ivermectin in a whole-body bath cured all patients by day 29 in a small study. ^{1 2 3 4 5}

How does the drug Natroba Topical Suspension differ from other scabies treatments?

Natroba Topical Suspension is unique because it is a topical treatment specifically formulated for scabies, whereas many existing treatments like permethrin and ivermectin are used for other conditions as well. Unlike oral treatments, it is applied directly to the skin, which may help target the mites more effectively at the site of infection. ^{1 6 7 8 9}

Research Team

Sharda Angl

Principal Investigator

Cipher Pharmaceuticals Inc.

Julie Aker, MT(ASCP)

Principal Investigator

Concentrics Research

William Miller, MD

Principal Investigator

Concentrics Research

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Topically applied thiabendazole in the treatment of scabies. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Case series of elderly patients with scabies topically applied with ivermectin via whole-body bathing. [2022]

3. India pubmed.ncbi.nlm.nih.gov

Comparison of safety, efficacy, and cost effectiveness of benzyl benzoate, permethrin, and ivermectin in patients of scabies. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Eleven Danish patients diagnosed with Scabies and treated with Tenutex&#174;. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Ivermectin safety in infants and children under 15 kg treated for scabies: a multicentric observational study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

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

7. New Zealand pubmed.ncbi.nlm.nih.gov

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

8. New Zealand pubmed.ncbi.nlm.nih.gov

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

9. Portugal pubmed.ncbi.nlm.nih.gov

[Treatment of drug resistant scabies]. [2013]