Dose Ranging Study of Ivermectin Treatment Conditioner in Subjects With Head Lice Infestation

Condition(s) targeted: Pediculus Humanus Capitis (Head Lice)

Intervention: ivermectin treatment conditioner (Drug); Placebo, vehicle control (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Topaz Pharmaceuticals Inc

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Sanofi Topaz

This is a Phase 2 single center study designed to compare the safety, local tolerability, and efficacy of 3 strengths of ivermectin treatment conditioner to placebo.

Official title: A Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of 3 Strengths of Ivermectin Treatment Conditioner and Placebo in Subjects With Pediculus Humanus Capitis (Head Lice) Infestation

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)

Secondary outcome:

Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control)

Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)

Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control).

Minimum age: 6 Months. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects who are at least 6 months old and weighing at least 15 kg.

- Infestation with head lice and viable nits.

- Are otherwise in a normal state of health.

- Willing and able to attend all study visits as scheduled.

- Agree not to cut or chemically treat their hair in the period between treatment and

the final visit.

- The subject and/or his/her parent/legal guardian have provided written informed

consent, and, if appropriate, the child has provided assent.

- Females of childbearing potential must have a negative urine pregnancy test at

screening and agree to take reasonable precautions against becoming pregnant during the study period. Exclusion Criteria:

- Subjects who have received any over the counter or prescription treatment for head

lice in the last 2 weeks.

- Subjects unable to comply with the study obligations and all study visits.

- Subjects with eczema or other chronic conditions of the scalp and skin.

- Subjects in a household with more than 5 infested members.

- Subjects with a history of allergy to ivermectin or any ingredients commonly included

in hair products such as shampoos, hair conditioners, or styling aids.

- Subjects with neurologic conditions including a seizure disorder or history of

seizures.

- Subjects with an infestation of body lice or pubic lice (determined by questioning).

- Subjects suffering from a condition likely to require medical attention, including

administration of oral or systemic antibiotics, oral or systemic corticosteroids, or any other treatment, which in the opinion of the Investigator and visiting physician could influence the results of the study.

- Subjects with other diagnoses which, in the opinion of the Investigator, would

interfere with efficacy or safety assessments or would preclude study participation.

- Subjects with very short (shaved) hair.

- Subjects who have been treated with a systemic antibiotic within the previous 2 weeks

before screening.

- Subjects who have been previously enrolled in any clinical study within the past 30

days; subjects may not participate in another study while participating in this study.

- Pregnant and/or nursing females.

Global Health Associates of Miami, Miami, Florida 33143, United States

Starting date: March 2009
Last updated: March 1, 2012