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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT02010333
Eligibility Criteria:
Inclusion Criteria:
1. Male or female, 6months \< 3years of age
2. Good health
3. Active head lice infestation defined as the presence of at least 3 live lice
4. Dermatological condition of scalp (at least G2 erythema or pruritus with evidence of excoriation/inflammation)
5. Parent/guardian agrees to allow PK samples collected
6. Signed Informed Consent Form
Exclusion Criteria:
1. Condition or illness that in the opinion of the investigator may interfere with the study results.
2. Current dermatological disease that may compromise the health of subject or the assessment of safety. Subjects with scalp ulceration or evidence of scalp infection should not be enrolled.
3. Prior reaction to product containing piperonyl butoxide, pyrethrin, or pyrethrum extract.
4. Receiving systemic or topical medication that may interfere the study results.
5. Received an investigational agent within 30 days prior to Day 0.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
2 Years
Study:
NCT02010333
Study Brief:
Protocol Section:
NCT02010333