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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
78
Application followed by thorough rinsing of the hair and scalp with water.
Application followed by thorough rinsing of the hair and scalp with water.
Global Health Associates of Miami
Miami, Florida, United States
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)
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.
Time frame: Day 1 through Day 15 post-application
Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
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.
Time frame: Day 1 through Day 8 post-application
Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
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.
Time frame: Day 1 through Day 15 post-application
Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control).
Time frame: Day 1 up to Day 28 post-application
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