Trial Outcomes & Findings for A Study of the Efficacy and Safety of Abametapir Lotion Administered for the Treatment of Head Lice Infestation (NCT NCT02060903)

NCT ID: NCT02060903

Last Updated: 2020-09-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

379 participants

Primary outcome timeframe

14 days

Results posted on

2020-09-23

Participant Flow

Participant milestones

Participant milestones
Measure	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	Vehicle Lotion Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver. Vehicle Lotion
Overall Study STARTED	187	192
Overall Study COMPLETED	183	185
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Reasons for withdrawal
Measure	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	Vehicle Lotion Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver. Vehicle Lotion
Overall Study Lost to Follow-up	4	0
Overall Study Withdrawal by Subject	0	7

Baseline Characteristics

A Study of the Efficacy and Safety of Abametapir Lotion Administered for the Treatment of Head Lice Infestation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abametapir Lotion 0.74% w/w n=187 Participants Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver. Abametapir Lotion 0.74% w/w	Vehicle Lotion n=192 Participants Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver. Vehicle Lotion	Total n=379 Participants Total of all reporting groups
Age, Continuous	16.28 years STANDARD_DEVIATION 12.11 • n=5 Participants	16.58 years STANDARD_DEVIATION 13.93 • n=7 Participants	16.43 years STANDARD_DEVIATION 13.02 • n=5 Participants
Sex: Female, Male Female	161 Participants n=5 Participants	160 Participants n=7 Participants	321 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	32 Participants n=7 Participants	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	142 Participants n=5 Participants	162 Participants n=7 Participants	304 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=5 Participants	30 Participants n=7 Participants	75 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	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	181 Participants n=5 Participants	191 Participants n=7 Participants	372 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	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	187 participants n=5 Participants	192 participants n=7 Participants	379 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Population: The ITT population consisted of all 108 index subjects who were enrolled and randomized in the study.

Outcome measures

Outcome measures
Measure	Abametapir Lotion 0.74% w/w n=53 Participants Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver. Abametapir Lotion 0.74% w/w	Vehicle Lotion n=55 Participants Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver. Vehicle Lotion
Proportion of Index Subjects Who Are Lice-free at All Follow-up Visits Through to the Day 14 Visit.	43 participants	28 participants

Adverse Events

Abametapir Lotion 0.74% w/w

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vehicle Lotion

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Abametapir Lotion 0.74% w/w n=186 participants at risk Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver. Abametapir Lotion 0.74% w/w	Vehicle Lotion n=188 participants at risk Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver. Vehicle Lotion
Renal and urinary disorders Renal Impairment	0.00% 0/186 • Adverse events will be collected from the start of treatment until 14 days following IP treatment (approximately 15 days).	0.53% 1/188 • Number of events 1 • Adverse events will be collected from the start of treatment until 14 days following IP treatment (approximately 15 days).

Other adverse events

Adverse event data not reported

Additional Information

Dr. Srinivas Sidgiddi

Dr. Reddy's Laboratories Inc.

Phone: 9084585362

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place