Clinical trial NCT00857948: Dose Ranging Study of Ivermectin Treatment Conditioner in Subjects With Head Lice Infestation
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pediculus Humanus Capitis (Head Lice)
Keywords: head lice
Pediculus humanus capitis
ivermectin
Lead sponsor: Topaz Pharmaceuticals Inc
Sponsor class: INDUSTRY
First posted: 2009-03-09
Enrollment: 78
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: 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)
timeFrame: Day 1 through Day 15 post-application
Secondary outcomes:
measure: Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
timeFrame: Day 1 through Day 8 post-application
measure: Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
timeFrame: Day 1 through Day 15 post-application
measure: Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control).
timeFrame: Day 1 up to Day 28 post-application
Other outcomes:
Locations:
city: Miami
country: United States
facility: Global Health Associates of Miami
state: Florida
Study officials:
affiliation: Sanofi Topaz
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Meinking TL, Mertz-Rivera K, Villar ME, Bell M. Assessment of the safety and efficacy of three concentrations of topical ivermectin lotion as a treatment for head lice infestation. Int J Dermatol. 2013 Jan;52(1):106-12. doi: 10.1111/j.1365-4632.2012.05629.x.