Title
Dose Ranging Study of Ivermectin Treatment Conditioner in Subjects With Head Lice Infestation
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
Phase
Phase 2Lead Sponsor
Topaz Pharmaceuticals IncStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Pediculus Humanus Capitis (Head Lice)Intervention/Treatment
ivermectin ...Study Participants
78This 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.
Application followed by thorough rinsing of the hair and scalp with water.
Application followed by thorough rinsing of the hair and scalp with water.
Participant on 0.15% ivermectin treatment conditioner
Participants on 0.25% ivermectin treatment conditioner
Participants on 0.50% ivermectin treatment conditioner
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.
| Event Type | Organ System | Event Term | 0.15% Ivermectin | 0.25% Ivermectin | 0.50% Ivermectin | Placebo |
|---|
Live lice eradication was assessed by visual checks of hair and scalp on Days 1, 2 and 8 and by visual checks and counting both live and dead lice from rinse water on Day 15. Eradication was defined as cessation of motility (antennae and leg movement) in all lice.
Live lice eradication was assessed on Days 1, 2, and 8 by visual checks of hair and scalp. Eradication was defined as cessation of motility (antennae and leg movement) in all lice.
The severity of lice infestation was determined by visual checks of hair and scalp. Severity was rated as None: no live lice; Mild: 1 to 5 live lice; Moderate: 6 to 10 live lice; Severe: 11 to 20 live lice; or Very severe > 20 live lice.
