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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00545168
Recruitment Status : Completed
First Posted : October 17, 2007
Results First Posted : October 11, 2012
Last Update Posted : October 11, 2012
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pediculus Capitis Infestation
Interventions: Drug: Spinosad
Drug: Permethrin 1%

  Participant Flow

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After admission to the study, subjects could have withdrawn at any time for any reason such as they no longer met the eligibility criteria, personal reasons, etc.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

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.
No text entered.

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 
Overall Participants Analyzed 
[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

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

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
No text entered.


  More Information

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



Responsible Party: ParaPRO LLC
ClinicalTrials.gov Identifier: NCT00545168     History of Changes
Other Study ID Numbers: SPN-302-07
First Submitted: October 15, 2007
First Posted: October 17, 2007
Results First Submitted: August 2, 2012
Results First Posted: October 11, 2012
Last Update Posted: October 11, 2012