Trial Outcomes & Findings for Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin (NCT NCT01514513)

NCT ID: NCT01514513

Last Updated: 2015-01-01

Results Overview

No live lice 15 days following initial treatment

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 42 participants
• Primary outcome timeframe: 15 days
• Results posted on: 2015-01-01

Participant Flow

Participant milestones

Measure	Licefreee Spray Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.	Nix Creme Rinse, 1% Permethrin 1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
Overall Study STARTED	21	21
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin

Baseline characteristics by cohort

Measure	Licefreee Spray n=21 Participants Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.	Nix Creme Rinse, 1% Permethrin n=21 Participants 1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.	Total n=42 Participants Total of all reporting groups
Age, Continuous	15.57 years n=5 Participants	14.76 years n=7 Participants	15.17 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	20 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	1 Participants n=7 Participants	9 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	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	19 Participants n=7 Participants	37 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 United States	21 participants n=5 Participants	21 participants n=7 Participants	42 participants n=5 Participants
Hair Length Extra long	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants
Hair Length Long	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants
Hair Length Medium	7 participants n=5 Participants	11 participants n=7 Participants	18 participants n=5 Participants
Hair Length Short	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Hair Texture Fine	8 participants n=5 Participants	4 participants n=7 Participants	12 participants n=5 Participants
Hair Texture Average	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants
Hair Texture Coarse	3 participants n=5 Participants	7 participants n=7 Participants	10 participants n=5 Participants
Hair Curliness Curly	1 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants
Hair Curliness Wavy	10 participants n=5 Participants	8 participants n=7 Participants	18 participants n=5 Participants
Hair Curliness Straight	10 participants n=5 Participants	8 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 15 days

No live lice 15 days following initial treatment

Outcome measures

Measure	Licefreee Spray n=20 Participants Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.	Nix Creme Rinse, 1% Permethrin n=20 Participants 1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
The Proportion Within Each Treatment Group of Subjects Who Have no Live Lice	17 participants	9 participants

SECONDARY outcome

Timeframe: 15 days

Number of participants with adverse events

Outcome measures

Measure	Licefreee Spray n=20 Participants Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.	Nix Creme Rinse, 1% Permethrin n=20 Participants 1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
Adverse Events	0 participants	0 participants

Adverse Events

Licefreee Spray

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nix Creme Rinse, 1% Permethrin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Wendy Langley

Tec Laboratories, Inc.

Phone: 5419264577

Email: wendy@teclabsinc.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place