Head Lice Infestation
Conditions
Brief summary
The purpose of the study was to evaluate ovicidal efficacy of a single application of abametapir lotion 0.74% w/w intended for the treatment of head lice.
Detailed description
This was a double-blind, randomised, vehicle-controlled, parallel group study in males and females, aged three years and older with active head lice infestation. The study was designed to assess the ovicidal efficacy 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 the study site. This study used an ex vivo method of assessment for ovicidal efficacy.
Interventions
200mL abametapir lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water.
DRUGVehicle Lotion
control to abametapir: 200mL Vehicle Lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water.
Sponsors
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. Healthy male or female based on medical history 2. Six months of age or older. 3. Has an active head lice infestation with a minimum of 3 live head lice and at least 10 undamaged and unhatched head lice eggs in their hair. 4. Agrees to an examination for head lice and compliance with the study procedures. 5. All adult subjects must sign a written voluntary informed consent. For minors, the parent/ legal guardian agrees to the subject participating in the study as determined by the signing of an assent of informed consent.
Exclusion criteria
1. Has scalp disease or a history of allergies or prior reactions to any head lice products. 2. Has a condition that, in the opinion of the Investigator, may interfere with the study. 3. Is receiving systemic or topical medication, which in the opinion of the Investigator, may compromise the integrity of the safety and/or efficacy assessments. 4. Had treatment (over-the-counter (OTC) or home remedy medication) for head lice within 14 days prior to Day 0. 5. Has received an investigational agent within 30 days prior to Day 0.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Hatched Eggs Pre Treatment Relative to Post Treatment | 14 days | Percentage of hatched eggs pre treatment relative to percentage of hatched eggs post treatment for the abametapir and vehicle treated eggs following 14 day incubation. The difference between post treatment percent hatching and pre-treatment percent hatching was calculated i.e. post-treatment minus pre-treatment hatching percent. |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Abametapir Lotion 0.74% w/w Topically administered to hair and scalp for 10 minutes application.
Abametapir Lotion 0.74% w/w: 200mL abametapir lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water. | 25 |
| Vehicle Lotion Administered to scalp and hair for 10 minutes application.
Vehicle Lotion: control to abametapir: 200mL Vehicle Lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water. | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Vehicle Lotion | Total | Abametapir Lotion 0.74% w/w |
|---|---|---|---|
| Age, Continuous | 8.3 years STANDARD_DEVIATION 2.95 | 8.5 years STANDARD_DEVIATION 3.18 | 8.7 years STANDARD_DEVIATION 3.43 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 50 Participants | 25 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 | 0 Participants | 0 Participants | 0 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 50 Participants | 25 Participants |
| Region of Enrollment Australia | 25 participants | 50 participants | 25 participants |
| Sex: Female, Male Female | 24 Participants | 45 Participants | 21 Participants |
| Sex: Female, Male Male | 1 Participants | 5 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 4 / 25 | 2 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Percentage of Hatched Eggs Pre Treatment Relative to Post Treatment
Percentage of hatched eggs pre treatment relative to percentage of hatched eggs post treatment for the abametapir and vehicle treated eggs following 14 day incubation. The difference between post treatment percent hatching and pre-treatment percent hatching was calculated i.e. post-treatment minus pre-treatment hatching percent.
Time frame: 14 days
Population: Full Analysis Set (FAS) included all randomized subjects who received any amount of study treatment and had at least 1 viable pre-treatment egg and 1 viable post-treatment egg evaluable for analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Abametapir Lotion 0.74% w/w | Percentage of Hatched Eggs Pre Treatment Relative to Post Treatment | -92.9 Percent hatched eggs post versus pre Rx |
| Vehicle Lotion | Percentage of Hatched Eggs Pre Treatment Relative to Post Treatment | -42.3 Percent hatched eggs post versus pre Rx |