Head Lice
Conditions
Keywords
Head lice infestation, Pediculus humanus capitis
Brief summary
The purpose of this study is to determine if 0.5% Ivermectin Cream is a safe and effective treatment for head lice infestations.
Interventions
Up to 4 ounces of 0.5% Ivermectin Cream applied to hair and scalp on day 1.
DRUGPlacebo control
up to 4 ounces of topical vehicle control to head and scalp on day 1.
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
5 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* Index subjects must have an active head lice infestation defined as: At least 3 live lice (adults and/or nymphs) present on the scalp and/or hair, as determined by a trained evaluator. The index subject must be the youngest family member presenting with at least 3 live lice. After the index subject has been identified, additional infested household members (see b below) will be enrolled. * Household subjects must have an active head lice infestation defined as: At least 1 live louse (adult and/or nymph) present on the scalp and/or hair, as determined by a trained evaluator (with the exception of the male head of household who may self-assess as being lice free). * Subject is male or female. * Subject is at least 6 months of age at time of enrollment. * Subject is in good general health based on medical history. * Each subject must have an appropriately signed Informed Consent agreement. A caregiver must sign an Informed Consent agreement for children not old enough to do so. Children of a specified age will be administered a child's assent form. * The caregiver of a subject must be willing to allow all household members to be screened for head lice. If other household members are found to have an active head lice infestation, according to the criteria b (above), they must be willing and able to participate in the study. No more than one working male per household may be excluded from evaluation if he is assessed as being lice free by himself or the caregiver and cannot come in due to his work schedule. If this individual may have lice, he must come to the test facility; otherwise the entire household will be excluded from study participation. * Subject and/or their caregiver must be physically able and willing to apply the test article. * Subject agrees not to use any other form of lice treatments (commercial, community-anecdotal, or mechanical/manual) while participating in the study. * Following application and rinsing of the test article, subject agrees not to shampoo, wash, or rinse their hair or scalp until the 24-hour post-treatment evaluation has been completed. * Subject agrees to not cut or chemically treat their hair while participating in the study. * Subject agrees to follow all study instructions. * Female subjects of childbearing potential (including a female caregiver even if she is not being treated) must be willing to have a urine pregnancy test. * In the event of a subject judged to be incapable of self-treating, the household must have a caregiver willing to apply the treatment at home.
Exclusion criteria
* History of irritation or sensitivity to ivermectin or the cream components, pediculicides or hair care products. * Presentation at the treatment site with visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score that is \>2, blisters, vesicles which, in the opinion of the investigative personnel or sponsor, will interfere with safety and/or efficacy evaluations. * Presentation at the treatment site with eczema or atopic dermatitis. * Treatment for head lice (over-the-counter \[OTC\], home remedy and/or Prescription) in the last 7 days. * Any condition or illness that, in the opinion of the investigator, may compromise the objective of the protocol. * Is receiving any other treatment which, in the opinion of the investigator or study monitor, may interfere with the study results. * Females (including caregivers who come in contact with the investigational product) who are pregnant, nursing or planning a pregnancy. (NOTE: female caregivers and all enrolled females of childbearing potential must have a negative urine pregnancy test prior to treatment). If a household has a pregnant female who has an active case of lice, the entire household is excluded from participation. If this pregnant household member does not have an active infestation, this individual must NOT be the caregiver (one who provides treatment to other household members). * Is of child-bearing potential and unwilling to use an adequate method of contraception for the duration of the study. Adequate methods of contraception include: abstinence, vasectomized partner, oral birth control pills, birth control injections or patches, intrauterine device, condoms with a spermicidal jelly or a diaphragm with spermicidal jelly, surgical sterilization. * Participation in a previous investigational drug study within the past 30 days. * Prior participation in any ivermectin trials. * Does not understand the requirements for study participation and/or may likely exhibit poor compliance, in the opinion of the investigator. * Does not have a known household affiliation with their household members (i.e., do not stay in one household consistently, sleeping at one place several nights and then at another place or location). Household is defined as living in a shared area or space (for example the same house or apartment unit).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Index Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 2 up to Day 15 post-application | Treatment success, defined as absence of live lice, was assessed in index subjects, defined as the youngest person within each household who had at least 3 live lice present at Screening (Day 1). Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation. |
| Percentage of All Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 2 up to Day 15 post-application | Treatment success, defined as absence of live lice, was assessed in all subjects. Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 2 up to Day 15 post-application | Adverse events were defined and classified as follows: 'Mild' - Awareness of signs or symptoms, but easily tolerated; 'Moderate' - Discomfort to a degree that adverse event/adverse drug reaction causes interference with normal daily life activities and/or requires medication; 'Severe' - Incapacity with regard to work or usual daily life activities. Requires medical attention/intervention. |
| Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 2 up to Day 15 post-application | Severe skin/scalp irritations were defined as follows: Severe Pruritus - Nearly constant, frequent scratching, very bothersome; Severe Erythema - large areas of the scalp are red; Severe Excoriation - Widespread breaking of the skin involving most of the scalp; Severe Pyoderma - Lesions with crusting or other evidence of infection, involving most of the scalp. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled and treated from 4 March 2010 to 17 June 2010 in 8 US clinical centers.
Pre-assignment details
A total of 371 participants who met the inclusion and exclusion criteria were enrolled and treated.
Participants by arm
| Arm | Count |
|---|---|
| 0.5% Ivermectin Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1. | 169 |
| Vehicle Control Participants underwent a single treatment with vehicle control cream at home on Day 1. | 202 |
| Total | 371 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 0 |
| Overall Study | Protocol Violation | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Vehicle Control | 0.5% Ivermectin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 150 Participants | 126 Participants | 276 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 52 Participants | 42 Participants | 94 Participants |
| Age Continuous | 15.19 Years STANDARD_DEVIATION 13.85 | 14.37 Years STANDARD_DEVIATION 13.33 | 14.82 Years STANDARD_DEVIATION 13.6 |
| Region of Enrollment United States | 202 Participants | 169 Participants | 371 Participants |
| Sex: Female, Male Female | 151 Participants | 136 Participants | 287 Participants |
| Sex: Female, Male Male | 51 Participants | 33 Participants | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 169 | 0 / 202 |
| serious Total, serious adverse events | 0 / 169 | 0 / 202 |
Outcome results
Primary
Percentage of All Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Treatment success, defined as absence of live lice, was assessed in all subjects. Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation.
Time frame: Day 2 up to Day 15 post-application
Population: Treatment success was assessed in the Intent-to-treat 2 (All Participants) 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) |
|---|---|---|---|
| 0.5% Ivermectin | Percentage of All Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 15 (LOCF Imputation) | 78 Percent of Participants |
| 0.5% Ivermectin | Percentage of All Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 15 (Treatment Failure Imputation) | 72 Percent of Participants |
| Vehicle Control | Percentage of All Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 15 (LOCF Imputation) | 23 Percent of Participants |
| Vehicle Control | Percentage of All Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 15 (Treatment Failure Imputation) | 21 Percent of Participants |
Primary
Percentage of Index Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Treatment success, defined as absence of live lice, was assessed in index subjects, defined as the youngest person within each household who had at least 3 live lice present at Screening (Day 1). Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation.
Time frame: Day 2 up to Day 15 post-application
Population: Treatment success was assessed in a subset of the Intent-to-treat population (Index participants). 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) |
|---|---|---|---|
| 0.5% Ivermectin | Percentage of Index Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 15 (LOCF Imputation) | 71 Percent of Participants |
| 0.5% Ivermectin | Percentage of Index Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 15 (Treatment Failure Imputation) | 69 Percent of Participants |
| Vehicle Control | Percentage of Index Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 15 (LOCF Imputation) | 19 Percent of Participants |
| Vehicle Control | Percentage of Index Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Day 15 (Treatment Failure Imputation) | 18 Percent of Participants |
Secondary
Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Adverse events were defined and classified as follows: 'Mild' - Awareness of signs or symptoms, but easily tolerated; 'Moderate' - Discomfort to a degree that adverse event/adverse drug reaction causes interference with normal daily life activities and/or requires medication; 'Severe' - Incapacity with regard to work or usual daily life activities. Requires medical attention/intervention.
Time frame: Day 2 up to Day 15 post-application
Population: Adverse events were assessed in the Intent-to-treat (Safety) 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) |
|---|---|---|---|
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Pyrexia | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Conjunctivitis | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Ocular Hyperemia | 1 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Ocular Hyperemia | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Toothache | 1 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Toothache | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Vomiting | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Vomiting | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Conjunctivitis | 1 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Pyrexia | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Otitis Media | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Otitis Media | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Excoriation | 1 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Excoriation | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Injury | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Injury | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Scratch | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Scratch | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Musculoskeletal Pain | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Musculoskeletal Pain | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Pain in Extremity | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Pain in Extremity | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Cough | 1 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Cough | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Dandruff | 1 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Dandruff | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Dry Skin | 1 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Dry Skin | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Erythema | 2 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Erythema | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Pruritus | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Pruritus | 0 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Pruritus | 0 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Conjunctivitis | 0 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Scratch | 1 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Conjunctivitis | 0 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Dandruff | 0 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Ocular Hyperemia | 1 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Scratch | 0 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Ocular Hyperemia | 0 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Erythema | 3 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Toothache | 0 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Musculoskeletal Pain | 1 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Toothache | 0 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Dandruff | 0 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Vomiting | 1 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Musculoskeletal Pain | 0 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Vomiting | 0 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Pruritus | 2 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Pyrexia | 1 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Pain in Extremity | 1 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Pyrexia | 0 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Dry Skin | 0 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Otitis Media | 1 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Pain in Extremity | 0 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Otitis Media | 0 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Erythema | 0 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Excoriation | 1 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Cough | 0 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Excoriation | 0 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Dry Skin | 0 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Injury | 1 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Cough | 0 Participants |
| Vehicle Control | Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Injury | 0 Participants |
Secondary
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe skin/scalp irritations were defined as follows: Severe Pruritus - Nearly constant, frequent scratching, very bothersome; Severe Erythema - large areas of the scalp are red; Severe Excoriation - Widespread breaking of the skin involving most of the scalp; Severe Pyoderma - Lesions with crusting or other evidence of infection, involving most of the scalp.
Time frame: Day 2 up to Day 15 post-application
Population: Skin/scalp irritation was assessed in the Intent-to-Treat (Safety) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Erythema Day 1 (Pre-treatment; N = 169, 202) | 45 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Pruritus Day 1 (Pre-treatment; N= 169, 202) | 12 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Pruritus Day 2 (N = 166, 200) | 55 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Pruritus Day 2 (N = 166, 200) | 1 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Pruritus Day 8 (N = 148, 58) | 19 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Pruritus Day 8 (N = 148, 58) | 0 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Pruritus Day 15 (N = 142, 53) | 13 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Pruritus Day 15 (N = 142, 53) | 0 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Pruritus Day 1 (Pre-treatment; N = 169, 202) | 124 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Erythema Day 1 (Pre-treatment; N= 169, 202) | 0 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Erythema Day 2 (N = 166, 200) | 31 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Erythema Day 2 (N = 166, 200) | 0 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Erythema Day 8 (N = 148, 58) | 8 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Erythema Day 8 (N = 148, 58) | 0 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Erythema Day 15 (N = 142, 53) | 4 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Erythema Day 15 (N = 142, 53) | 0 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Excoriation Day 1 (Pre-treatment; N= 169, 202) | 42 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Excoriation Day 1 (Pre-treatment N=169, 202 | 0 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Excoriation Day 2 (N = 166, 200) | 36 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Excoriation Day 2 (N = 166, 200) | 0 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Excoriation Day 8 (N = 148, 58) | 13 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Excoriation Day 8 (N = 148, 58) | 0 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Excoriation Day 15 (N = 142, 53) | 5 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Excoriation Day 15 (N = 142, 53) | 0 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Pyoderma Day 1 (Pre-treatment; N= 169, 202) | 3 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Pyoderma Day 1 (Pre-treatment; N= 169, 202) | 0 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Pyoderma Day 2 (N = 166, 200) | 3 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Pyoderma Day 2 (N = 166, 200) | 0 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Pyoderma Day 8 (N = 148, 58) | 1 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Pyoderma Day 8 (N = 148, 58) | 0 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Pyoderma Day 15 (N = 142, 53) | 2 Participants |
| 0.5% Ivermectin | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Pyoderma Day 15 (N = 142, 53) | 0 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Pyoderma Day 15 (N = 142, 53) | 0 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Pruritus Day 1 (Pre-treatment; N = 169, 202) | 147 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Excoriation Day 1 (Pre-treatment; N= 169, 202) | 46 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Pruritus Day 1 (Pre-treatment; N= 169, 202) | 8 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Pyoderma Day 1 (Pre-treatment; N= 169, 202) | 2 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Pruritus Day 2 (N = 166, 200) | 104 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Excoriation Day 1 (Pre-treatment N=169, 202 | 1 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Pruritus Day 2 (N = 166, 200) | 2 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Pyoderma Day 8 (N = 148, 58) | 1 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Pruritus Day 8 (N = 148, 58) | 14 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Excoriation Day 2 (N = 166, 200) | 46 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Pruritus Day 8 (N = 148, 58) | 0 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Pyoderma Day 1 (Pre-treatment; N= 169, 202) | 0 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Pruritus Day 15 (N = 142, 53) | 8 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Excoriation Day 2 (N = 166, 200) | 1 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Pruritus Day 15 (N = 142, 53) | 0 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Pyoderma Day 15 (N = 142, 53) | 1 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Erythema Day 1 (Pre-treatment; N = 169, 202) | 53 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Excoriation Day 8 (N = 148, 58) | 5 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Erythema Day 1 (Pre-treatment; N= 169, 202) | 0 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Pyoderma Day 2 (N = 166, 200) | 2 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Erythema Day 2 (N = 166, 200) | 41 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Excoriation Day 8 (N = 148, 58) | 0 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Erythema Day 2 (N = 166, 200) | 0 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Pyoderma Day 8 (N = 148, 58) | 0 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Erythema Day 8 (N = 148, 58) | 1 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Excoriation Day 15 (N = 142, 53) | 4 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Erythema Day 8 (N = 148, 58) | 0 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Pyoderma Day 2 (N = 166, 200) | 0 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Any Erythema Day 15 (N = 142, 53) | 0 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Excoriation Day 15 (N = 142, 53) | 0 Participants |
| Vehicle Control | Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe Erythema Day 15 (N = 142, 53) | 0 Participants |