Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ParaPRO LLC
ClinicalTrials.gov Identifier:
NCT00545168
First received: October 15, 2007
Last updated: September 10, 2012
Last verified: September 2012
Results First Received: August 2, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pediculus Capitis Infestation
Interventions: Drug: Spinosad
Drug: Permethrin 1%

  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
The first subject signed an informed consent and enrolled into the study on 21 September 2007; the last follow up visit occurred on 8 April 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After admission to the study, subjects could have withdrawn at any time for any reason such as they no longer met the eligibility criteria, personal reasons, etc.

Reporting Groups
  Description
A - NatrOVA 1% - no Nit Combing NatrOVA Creme Rinse (spinosad) 1% - no nit combing required Spinosad
B - NatrOVA 1% - Nit Combing Required NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required
C - NIX NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use

Participant Flow:   Overall Study
    A - NatrOVA 1% - no Nit Combing     B - NatrOVA 1% - Nit Combing Required     C - NIX  
STARTED     203     63     214  
COMPLETED     187     58     193  
NOT COMPLETED     16     5     21  
Lost to Follow-up                 5                 5                 5  
Withdrawal by Subject                 9                 0                 13  
Protocol Violation                 1                 0                 1  
Visit for Day 21 was not done in error                 1                 0                 2  



  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
A - NatrOVA 1% - no Nit Combing NatrOVA Creme Rinse (spinosad) 1% - no nit combing required Spinosad
B - NatrOVA 1% - Nit Combing Required NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required
C - NIX Nix Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC) Instructions for Use
Total Total of all reporting groups

Baseline Measures
    A - NatrOVA 1% - no Nit Combing     B - NatrOVA 1% - Nit Combing Required     C - NIX     Total  
Number of Participants  
[units: participants]
  203     63     214     480  
Age  
[units: participants]
       
<=18 years     147     46     147     340  
Between 18 and 65 years     56     17     64     137  
>=65 years     0     0     3     3  
Age  
[units: years]
Mean ± Standard Deviation
  15  ± 14     14  ± 13     16  ± 15     16  ± 14  
Gender  
[units: participants]
       
Female     166     48     185     399  
Male     37     15     29     81  
Region of Enrollment  
[units: participants]
       
United States     203     63     214     480  



  Outcome Measures
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1.  Primary:   Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice   [ Time Frame: Assessment were made 14 days following the final product treatment ]

2.  Secondary:   Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions.   [ Time Frame: Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments) ]


  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: Director, Quality and Regulatory
Organization: ParaPRO LLC
phone: 317-810-6205
e-mail: kerrym@parapro.com


No publications provided


Responsible Party: ParaPRO LLC
ClinicalTrials.gov Identifier: NCT00545168     History of Changes
Other Study ID Numbers: SPN-302-07
Study First Received: October 15, 2007
Results First Received: August 2, 2012
Last Updated: September 10, 2012
Health Authority: United States: Food and Drug Administration