Trial Outcomes & Findings for Ovicidal Efficacy and Safety of Abametapir Lotion 0.74% Administered for the Treatment of Head Lice Infestation (NCT NCT02097485)
NCT ID: NCT02097485
Last Updated: 2021-05-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
14 days
Results posted on
2021-05-11
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ovicidal Efficacy and Safety of Abametapir Lotion 0.74% Administered for the Treatment of Head Lice Infestation
Baseline characteristics by cohort
| Measure |
Abametapir Lotion 0.74% w/w
n=25 Participants
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.
|
Vehicle Lotion
n=25 Participants
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.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.7 years
STANDARD_DEVIATION 3.43 • n=5 Participants
|
8.3 years
STANDARD_DEVIATION 2.95 • n=7 Participants
|
8.5 years
STANDARD_DEVIATION 3.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: 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.
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.
Outcome measures
| Measure |
Abametapir Lotion 0.74% w/w
n=25 Participants
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.
|
Vehicle Lotion
n=25 Participants
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.
|
|---|---|---|
|
Percentage of Hatched Eggs Pre Treatment Relative to Post Treatment
|
-92.9 Percent hatched eggs post versus pre Rx
Interval -99.4 to -86.5
|
-42.3 Percent hatched eggs post versus pre Rx
Interval -54.4 to -30.2
|
Adverse Events
Abametapir Lotion 0.74% w/w
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Vehicle Lotion
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Abametapir Lotion 0.74% w/w
n=25 participants at risk
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.
|
Vehicle Lotion
n=25 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
16.0%
4/25 • Number of events 4 • AEs were collected from the start of treatment on Day 0 through the Day 7 follow up visit (Approximately 8 days).
|
8.0%
2/25 • Number of events 2 • AEs were collected from the start of treatment on Day 0 through the Day 7 follow up visit (Approximately 8 days).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place