Pediculus Humanus Capitis (Head Lice)
Conditions
Keywords
head lice, Pediculus humanus capitis, ivermectin
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.
Interventions
DRUGivermectin treatment conditioner
Application followed by thorough rinsing of the hair and scalp with water.
Application followed by thorough rinsing of the hair and scalp with water.
Sponsors
Topaz Pharmaceuticals Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
| 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 | — |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled and treated on 14 March 2009 in 1 US clinical center.
Pre-assignment details
A total of 78 participants who met the inclusion and exclusion criteria were enrolled and treated.
Participants by arm
| Arm | Count |
|---|---|
| 0.15% Ivermectin Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1. | 18 |
| 0.25% Ivermectin Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1. | 18 |
| 0.50% Ivermectin Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1. | 19 |
| Placebo Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1. | 23 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | 0.25% Ivermectin | 0.50% Ivermectin | 0.15% Ivermectin | Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 14 Participants | 13 Participants | 16 Participants | 21 Participants | 64 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 6 Participants | 2 Participants | 2 Participants | 14 Participants |
| Age Continuous Age Continuous | 14.11 Years STANDARD_DEVIATION 8.71 | 14.21 Years STANDARD_DEVIATION 12.87 | 12.28 Years STANDARD_DEVIATION 13 | 11.13 Years STANDARD_DEVIATION 8.73 | 12.83 Years STANDARD_DEVIATION 10.79 |
| Region of Enrollment United States | 18 Participants | 19 Participants | 18 Participants | 23 Participants | 78 Participants |
| Sex: Female, Male Female | 15 Participants | 18 Participants | 15 Participants | 22 Participants | 70 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 3 Participants | 1 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 18 | 3 / 18 | 5 / 19 | 5 / 23 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 | 0 / 19 | 0 / 23 |
Outcome results
Primary
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
Population: Live lice eradication was assessed in the Intent-to-treat Population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 0.15% Ivermectin | 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) | 56 Percent of participants |
| 0.25% Ivermectin | 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) | 50 Percent of participants |
| 0.50% Ivermectin | 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) | 74 Percent of participants |
| Placebo | 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) | 9 Percent of participants |
Secondary
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
Population: The level of lice infestation was assessed in the Intent-to-treat population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.15% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 2 Hours Post Dose: None | 33 Percent of participants |
| 0.15% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 8: Moderate | 0 Percent of participants |
| 0.15% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 8: Mild | 11 Percent of participants |
| 0.15% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 6 Hours Post Dose: Moderate | 11 Percent of participants |
| 0.15% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 8: None | 72 Percent of participants |
| 0.15% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 6 Hours Post Dose: None | 50 Percent of participants |
| 0.15% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 15: Treatment Failure Day 8 | 33 Percent of participants |
| 0.15% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 2: None | 83 Percent of participants |
| 0.15% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 8: Treatment Failure Day 2 | 17 Percent of participants |
| 0.15% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 15: Mild | 11 Percent of participants |
| 0.15% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 2 Hours Post Dose: Mild | 50 Percent of participants |
| 0.15% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 2: Mild | 17 Percent of participants |
| 0.15% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 15: None | 56 Percent of participants |
| 0.15% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 2 Hours Post Dose: Moderate | 17 Percent of participants |
| 0.15% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 8: Severe | 0 Percent of participants |
| 0.15% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 2: Moderate | 0 Percent of participants |
| 0.15% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 6 Hours Post Dose: Mild | 39 Percent of participants |
| 0.25% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 2: Moderate | 0 Percent of participants |
| 0.25% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 8: Moderate | 6 Percent of participants |
| 0.25% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 8: Treatment Failure Day 2 | 6 Percent of participants |
| 0.25% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 15: Mild | 17 Percent of participants |
| 0.25% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 8: None | 72 Percent of participants |
| 0.25% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 8: Mild | 6 Percent of participants |
| 0.25% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 15: None | 56 Percent of participants |
| 0.25% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 6 Hours Post Dose: None | 67 Percent of participants |
| 0.25% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 6 Hours Post Dose: Mild | 33 Percent of participants |
| 0.25% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 2 Hours Post Dose: Mild | 56 Percent of participants |
| 0.25% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 15: Treatment Failure Day 8 | 28 Percent of participants |
| 0.25% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 6 Hours Post Dose: Moderate | 0 Percent of participants |
| 0.25% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 2 Hours Post Dose: None | 44 Percent of participants |
| 0.25% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 2: None | 94 Percent of participants |
| 0.25% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 8: Severe | 11 Percent of participants |
| 0.25% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 2: Mild | 6 Percent of participants |
| 0.25% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 2 Hours Post Dose: Moderate | 0 Percent of participants |
| 0.50% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 8: None | 84 Percent of participants |
| 0.50% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 2 Hours Post Dose: None | 32 Percent of participants |
| 0.50% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 2 Hours Post Dose: Mild | 63 Percent of participants |
| 0.50% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 2 Hours Post Dose: Moderate | 5 Percent of participants |
| 0.50% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 6 Hours Post Dose: None | 58 Percent of participants |
| 0.50% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 6 Hours Post Dose: Mild | 37 Percent of participants |
| 0.50% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 6 Hours Post Dose: Moderate | 5 Percent of participants |
| 0.50% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 2: None | 95 Percent of participants |
| 0.50% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 2: Mild | 5 Percent of participants |
| 0.50% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 2: Moderate | 0 Percent of participants |
| 0.50% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 8: Treatment Failure Day 2 | 5 Percent of participants |
| 0.50% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 8: Mild | 5 Percent of participants |
| 0.50% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 8: Moderate | 0 Percent of participants |
| 0.50% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 8: Severe | 5 Percent of participants |
| 0.50% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 15: Treatment Failure Day 8 | 16 Percent of participants |
| 0.50% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 15: None | 74 Percent of participants |
| 0.50% Ivermectin | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 15: Mild | 11 Percent of participants |
| Placebo | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 8: Moderate | 0 Percent of participants |
| Placebo | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 2: Mild | 78 Percent of participants |
| Placebo | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 2: None | 17 Percent of participants |
| Placebo | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 2 Hours Post Dose: Mild | 65 Percent of participants |
| Placebo | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 8: Severe | 0 Percent of participants |
| Placebo | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 6 Hours Post Dose: Moderate | 9 Percent of participants |
| Placebo | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 6 Hours Post Dose: Mild | 61 Percent of participants |
| Placebo | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 2 Hours Post Dose: None | 22 Percent of participants |
| Placebo | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 15: Treatment Failure Day 8 | 91 Percent of participants |
| Placebo | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 6 Hours Post Dose: None | 30 Percent of participants |
| Placebo | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 2 Hours Post Dose: Moderate | 13 Percent of participants |
| Placebo | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 8: None | 9 Percent of participants |
| Placebo | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 15: Mild | 0 Percent of participants |
| Placebo | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 8: Mild | 9 Percent of participants |
| Placebo | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 8: Treatment Failure Day 2 | 83 Percent of participants |
| Placebo | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 2: Moderate | 4 Percent of participants |
| Placebo | Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 15: None | 9 Percent of participants |
Secondary
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
Population: Adverse events were assess in the Safety (Intent-to-treat) Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.15% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Severe Pruritus | 0 Participants |
| 0.15% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Severe Skin Irritation | 0 Participants |
| 0.15% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Severe Folliculitis | 0 Participants |
| 0.15% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Conjunctivitis | 0 Participants |
| 0.15% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Pruritus | 5 Participants |
| 0.15% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Eye Pruritus | 1 Participants |
| 0.15% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Severe Eye Pruritus | 0 Participants |
| 0.15% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Severe Conjunctivitis | 0 Participants |
| 0.15% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Skin Irritation | 0 Participants |
| 0.15% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Erythema | 0 Participants |
| 0.15% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Severe Erythema | 0 Participants |
| 0.15% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Folliculitis | 0 Participants |
| 0.25% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Severe Conjunctivitis | 0 Participants |
| 0.25% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Folliculitis | 1 Participants |
| 0.25% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Severe Eye Pruritus | 0 Participants |
| 0.25% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Pruritus | 1 Participants |
| 0.25% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Severe Pruritus | 0 Participants |
| 0.25% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Severe Folliculitis | 0 Participants |
| 0.25% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Conjunctivitis | 0 Participants |
| 0.25% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Severe Erythema | 0 Participants |
| 0.25% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Erythema | 0 Participants |
| 0.25% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Eye Pruritus | 0 Participants |
| 0.25% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Severe Skin Irritation | 0 Participants |
| 0.25% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Skin Irritation | 0 Participants |
| 0.50% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Severe Folliculitis | 0 Participants |
| 0.50% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Conjunctivitis | 1 Participants |
| 0.50% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Severe Conjunctivitis | 0 Participants |
| 0.50% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Eye Pruritus | 0 Participants |
| 0.50% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Severe Eye Pruritus | 0 Participants |
| 0.50% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Erythema | 1 Participants |
| 0.50% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Severe Erythema | 0 Participants |
| 0.50% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Folliculitis | 0 Participants |
| 0.50% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Pruritus | 3 Participants |
| 0.50% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Severe Pruritus | 0 Participants |
| 0.50% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Skin Irritation | 0 Participants |
| 0.50% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Severe Skin Irritation | 0 Participants |
| Placebo | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Severe Erythema | 0 Participants |
| Placebo | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Erythema | 3 Participants |
| Placebo | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Conjunctivitis | 0 Participants |
| Placebo | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Severe Pruritus | 0 Participants |
| Placebo | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Severe Eye Pruritus | 0 Participants |
| Placebo | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Eye Pruritus | 0 Participants |
| Placebo | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Severe Skin Irritation | 0 Participants |
| Placebo | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Skin Irritation | 1 Participants |
| Placebo | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Severe Folliculitis | 0 Participants |
| Placebo | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Folliculitis | 1 Participants |
| Placebo | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Severe Conjunctivitis | 0 Participants |
| Placebo | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). | Pruritus | 1 Participants |
Secondary
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
Population: Live lice eradication was assessed in the Intent-to-treat Population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.15% Ivermectin | Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 2 hours post-application | 33 Percent of participants |
| 0.15% Ivermectin | Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 6 hours post-application | 50 Percent of participants |
| 0.15% Ivermectin | Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 2 | 83 Percent of participants |
| 0.15% Ivermectin | Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 8 | 67 Percent of participants |
| 0.25% Ivermectin | Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 6 hours post-application | 67 Percent of participants |
| 0.25% Ivermectin | Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 2 | 94 Percent of participants |
| 0.25% Ivermectin | Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 8 | 72 Percent of participants |
| 0.25% Ivermectin | Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 2 hours post-application | 44 Percent of participants |
| 0.50% Ivermectin | Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 2 | 95 Percent of participants |
| 0.50% Ivermectin | Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 6 hours post-application | 58 Percent of participants |
| 0.50% Ivermectin | Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 8 | 84 Percent of participants |
| 0.50% Ivermectin | Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 2 hours post-application | 32 Percent of participants |
| Placebo | Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 8 | 9 Percent of participants |
| Placebo | Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 6 hours post-application | 30 Percent of participants |
| Placebo | Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 1: 2 hours post-application | 22 Percent of participants |
| Placebo | Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 2 | 17 Percent of participants |