Head Lice Infestation
Conditions
Keywords
Head Lice, Hatchtech
Brief summary
The purpose of the study was to assess the efficacy, safety and tolerability of a single application of abametapir lotion 0.74% w/w compared to a vehicle control, when applied to the scalp and hair for 10 minutes at home.
Detailed description
This was a randomized, double-blind, multicenter, vehicle-controlled, parallel-group study in subjects with active head lice infestation. The study was designed to assess the efficacy, safety and tolerability of a single application of abametapir lotion 0.74% w/w compared to a vehicle control, when applied to scalp and hair for 10 minutes at home. Approximately 106 index subjects with their household members were enrolled into the study. A total of approximately 318 subjects were enrolled, assuming an average of 3 members per household participating in the study.
Interventions
Abametapir Lotion 0.74% was dispensed to subjects on Day 0 for self-administration at home on the same day.
DRUGVehicle Lotion
Vehicle Lotion was dispensed to subjects on Day 0 for self-administration at home on the same day.
Sponsors
Accelovance
Syneos Health
Dr. Reddy's Laboratories Limited
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
1. Male or female, aged six months of age or older. 2. Is in good general health based on medical history. 3. Has active head lice infestation at Screening as determined by a trained evaluator with the exception of the male head of household who may self-assess as being lice-free. Active head lice infestation is defined as at least three live lice for the index subject and at least one live louse for the other household members. 4. The subject and/or their caregiver is physically able and willing to apply the Investigational Product at home. 5. Belongs to a household with an eligible index subject with active head lice infestation. 6. Agrees to an examination for head lice and to all visits and procedures throughout the study. 7. Has signed an informed consent and/or assent form.
Exclusion criteria
1. Had treatment (over-the-counter ), home remedy or prescription medication) for head lice within 14 days prior to Day 0. 2. Intends to use any other form of lice treatment from Day 0 through the Day 14 visit, unless provided as rescue therapy to this Protocol. 3. Intends to use a lice comb from the Day 0 through the Day 14 visit unless provided as rescue therapy to this Protocol. 4. Intends to cut their hair, use hair dye/bleach or have permanent wave hairstyling from Day 0 through the Day 14 visit. 5. Has a household member(s) who is infested with lice but is not willing or not eligible for enrollment. 6. Has a condition that, in the opinion of the Investigator, may increase the risk to the subject and/or the interpretation of the data. 7. Has 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. 8. Has eczema or atopic dermatitis of skin/scalp. 9. Has had a prior reaction to Nix® or products containing permethrin. 10. Receiving systemic or topical medication, which in the opinion of the Investigator, may compromise the integrity of the safety and/or efficacy assessments. 11. Has received an investigational agent within 30 days prior to Day 0. 12. Does not have a known household affiliation with the household members (i.e., does not stay in one household consistently, or sleeps at one place for several nights and then at another place or location).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Index Subjects Who Are Lice-free at All Follow-up Visits Through to the Day 14 Visit. | 14 days | Proportion of index subjects randomized into the study who are lice free at all follow up visits through to the Day 14 visit. The index subject of a household was the youngest person within that household with at least 3 live lice present, as assessed over a period of up to 15 minutes at the Screening Visit. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Abametapir Lotion 0.74% w/w Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver.
Abametapir Lotion 0.74% w/w | 187 |
| Vehicle Lotion Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver.
Vehicle Lotion | 192 |
| Total | 379 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 7 |
Baseline characteristics
| Characteristic | Total | Abametapir Lotion 0.74% w/w | Vehicle Lotion |
|---|---|---|---|
| Age, Continuous | 16.43 years STANDARD_DEVIATION 13.02 | 16.28 years STANDARD_DEVIATION 12.11 | 16.58 years STANDARD_DEVIATION 13.93 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 304 Participants | 142 Participants | 162 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 75 Participants | 45 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 372 Participants | 181 Participants | 191 Participants |
| Region of Enrollment United States | 379 participants | 187 participants | 192 participants |
| Sex: Female, Male Female | 321 Participants | 161 Participants | 160 Participants |
| Sex: Female, Male Male | 58 Participants | 26 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 186 | 0 / 188 |
| other Total, other adverse events | 0 / 186 | 0 / 188 |
| serious Total, serious adverse events | 0 / 186 | 1 / 188 |
Outcome results
Primary
Proportion of Index Subjects Who Are Lice-free at All Follow-up Visits Through to the Day 14 Visit.
Proportion of index subjects randomized into the study who are lice free at all follow up visits through to the Day 14 visit. The index subject of a household was the youngest person within that household with at least 3 live lice present, as assessed over a period of up to 15 minutes at the Screening Visit.
Time frame: 14 days
Population: The ITT population consisted of all 108 index subjects who were enrolled and randomized in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abametapir Lotion 0.74% w/w | Proportion of Index Subjects Who Are Lice-free at All Follow-up Visits Through to the Day 14 Visit. | 43 participants |
| Vehicle Lotion | Proportion of Index Subjects Who Are Lice-free at All Follow-up Visits Through to the Day 14 Visit. | 28 participants |