Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
South Florida Family Health and Research Centers
ClinicalTrials.gov Identifier:
NCT01514513
First received: January 11, 2012
Last updated: December 18, 2014
Last verified: December 2014
Results First Received: December 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pediculosis Capitis
Interventions: Drug: Licefreee Spray
Drug: 1% permethrin creme rinse

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Licefreee Spray     Nix Creme Rinse, 1% Permethrin  
STARTED     21     21  
COMPLETED     20     20  
NOT COMPLETED     1     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
    Licefreee Spray     Nix Creme Rinse, 1% Permethrin     Total  
Number of Participants  
[units: participants]
  21     21     42  
Age  
[units: years]
Mean (Full Range)
  15.57  
  (6 to 43)  
  14.76  
  (4 to 42)  
  15.17  
  (4 to 43)  
Gender  
[units: participants]
     
Female     18     20     38  
Male     3     1     4  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     13     20     33  
Not Hispanic or Latino     8     1     9  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     2     0     2  
Asian     0     2     2  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     1     0     1  
White     18     19     37  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     21     21     42  
Hair Length  
[units: participants]
     
Extra long     5     3     8  
Long     7     6     13  
Medium     7     11     18  
Short     2     1     3  
Hair Texture  
[units: participants]
     
Fine     8     4     12  
Average     10     10     20  
Coarse     3     7     10  
Hair Curliness  
[units: participants]
     
Curly     1     5     6  
Wavy     10     8     18  
Straight     10     8     18  



  Outcome Measures
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1.  Primary:   The Proportion Within Each Treatment Group of Subjects Who Have no Live Lice   [ Time Frame: 15 days ]

2.  Secondary:   Adverse Events   [ Time Frame: 15 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: wendy@teclabsinc.com



Responsible Party: South Florida Family Health and Research Centers
ClinicalTrials.gov Identifier: NCT01514513     History of Changes
Other Study ID Numbers: LF001-0011
Study First Received: January 11, 2012
Results First Received: December 3, 2014
Last Updated: December 18, 2014
Health Authority: United States: Institutional Review Board