Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT05310734
Eligibility Criteria:
Inclusion Criteria:
1. Male or female, ages 1 month to 3 years and 11 months.
2. 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.
3. Generally, in good health based on medical history and clinical assessments.
4. Normal-appearing skin in non-infested areas.
5. No history of chronic or recurrent dermatologic disease.
6. Willingness to comply with the study procedures including blood collections and application of study treatment in-clinic.
Exclusion Criteria:
1. Presence of crusted scabies (Norwegian scabies).
2. Allergies or intolerance to ingredients in the Investigational Product.
3. Known renal or hepatic impairment.
4. Treatment with scabicide within the prior 2 weeks.
5. Immunodeficiency (including HIV infection) as reported in Medical History.
6. Signs or symptoms of systemic infection.
7. Administration of systemic therapy for infectious disease within the prior 2 weeks.
8. Receipt of any investigational product within the prior 4 weeks.
9. Medications used for itching or other indication that contain benzyl alcohol or other alcohols within the past 7 days.
10. Over-the-counter cortisone products within the past 7 days.
11. Oral prescription medications and/or antibiotics within the past 7 days.
12. 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
4 Years
Study:
NCT05310734
Study Brief:
Protocol Section:
NCT05310734