A Pediatric Safety and Pharmacokinetics Study of Ha44 Gel Administered Topically for Treatment of Head Lice Infestation

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.