NCT00857948
Completed
Phase 2
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
ConditionsPediculus Humanus Capitis (Head Lice)
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Topaz Pharmaceuticals Inc
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- 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)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Months to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Placebo
Placebo Comparator
participants on Placebo (Vehicle control)
Intervention: Placebo, vehicle control (Drug)
0.15% ivermectin
Experimental
Participant on 0.15% ivermectin treatment conditioner
Intervention: ivermectin treatment conditioner (Drug)
0.25% ivermectin
Experimental
Participants on 0.25% ivermectin treatment conditioner
Intervention: ivermectin treatment conditioner (Drug)
0.50% ivermectin
Experimental
Participants on 0.50% ivermectin treatment conditioner
Intervention: ivermectin treatment conditioner (Drug)
Outcomes
Primary Outcomes
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)
Time Frame: Day 1 through Day 15 post-application
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.
Secondary Outcomes
- Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control)(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)(Day 1 through Day 15 post-application)
- Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control).(Day 1 up to Day 28 post-application)
Investigators
Study Sites (1)
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