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Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin

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ClinicalTrials.gov Identifier: NCT01514513
Recruitment Status : Completed
First Posted : January 23, 2012
Results First Posted : January 1, 2015
Last Update Posted : January 1, 2015
Sponsor:
Information provided by (Responsible Party):
South Florida Family Health and Research Centers

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pediculosis Capitis
Interventions Drug: Licefreee Spray
Drug: 1% permethrin creme rinse
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Licefreee Spray Nix Creme Rinse, 1% Permethrin
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 21 21
Completed 20 20
Not Completed 1 1
Arm/Group Title Licefreee Spray Nix Creme Rinse, 1% Permethrin Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 21 21 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 21 participants 21 participants 42 participants
15.57
(6 to 43)
14.76
(4 to 42)
15.17
(4 to 43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
Female
18
  85.7%
20
  95.2%
38
  90.5%
Male
3
  14.3%
1
   4.8%
4
   9.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
Hispanic or Latino
13
  61.9%
20
  95.2%
33
  78.6%
Not Hispanic or Latino
8
  38.1%
1
   4.8%
9
  21.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
American Indian or Alaska Native
2
   9.5%
0
   0.0%
2
   4.8%
Asian
0
   0.0%
2
   9.5%
2
   4.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   4.8%
0
   0.0%
1
   2.4%
White
18
  85.7%
19
  90.5%
37
  88.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 21 participants 42 participants
21 21 42
Hair Length  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
Extra long 5 3 8
Long 7 6 13
Medium 7 11 18
Short 2 1 3
Hair Texture  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
Fine 8 4 12
Average 10 10 20
Coarse 3 7 10
Hair Curliness  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
Curly 1 5 6
Wavy 10 8 18
Straight 10 8 18
1.Primary Outcome
Title The Proportion Within Each Treatment Group of Subjects Who Have no Live Lice
Hide Description No live lice 15 days following initial treatment
Time Frame 15 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Licefreee Spray Nix Creme Rinse, 1% Permethrin
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: participants
17 9
2.Secondary Outcome
Title Adverse Events
Hide Description Number of participants with adverse events
Time Frame 15 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Licefreee Spray Nix Creme Rinse, 1% Permethrin
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: participants
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Licefreee Spray Nix Creme Rinse, 1% Permethrin
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Licefreee Spray Nix Creme Rinse, 1% Permethrin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Licefreee Spray Nix Creme Rinse, 1% Permethrin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Licefreee Spray Nix Creme Rinse, 1% Permethrin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Wendy Langley
Organization: Tec Laboratories, Inc.
Phone: 5419264577 ext 338
Responsible Party: South Florida Family Health and Research Centers
ClinicalTrials.gov Identifier: NCT01514513     History of Changes
Other Study ID Numbers: LF001-0011
First Submitted: January 11, 2012
First Posted: January 23, 2012
Results First Submitted: December 3, 2014
Results First Posted: January 1, 2015
Last Update Posted: January 1, 2015