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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

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ClinicalTrials.gov Identifier: NCT00545753
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):
ParaPRO LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pediculosis
Interventions Drug: Spinosad
Drug: Permethrin 1%
Enrollment 558
Recruitment Details The first subject signed an informed consent and enrolled into the study on 25 September 2007; the last follow-up visit occurred on 22 April 2008.
Pre-assignment Details After admission to the study, subjects could have withdrawn at any time for any reason such as they no longer met the eligibility criteria, personal reasons, etc.
Arm/Group Title A - NatrOVA 1% - No Nit Combing Required B - NatrOVA 1% - Nit Combing Required C - NIX Applied Per Over the Counter (OTC) Instructions
Hide Arm/Group Description NatrOVA Creme Rinse (spinosad) 1% - no nit combing required NatrOVA Creme Rinse (spinosad) 1% - nit comb regimen required NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use
Period Title: Overall Study
Started 243 59 256
Completed 227 54 230
Not Completed 16 5 26
Reason Not Completed
Withdrawal by Subject             0             1             10
Lost to Follow-up             13             3             12
Protocol Violation             3             1             4
Arm/Group Title A - NatrOVA 1% - No Nit Combing Required B - NatrOVA 1% - Nit Combing Required C - NIX Applied Per Over the Counter (OTC) Instructions Total
Hide Arm/Group Description NatrOVA Creme Rinse - 1% - no nit combing required NatrOVA Creme Rinse - 1% - nit comb regimen required NIX Creme Rinse applied to Over the Counter (OTC) Instructions for Use Total of all reporting groups
Overall Number of Baseline Participants 243 59 256 558
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 243 participants 59 participants 256 participants 558 participants
<=18 years
172
  70.8%
40
  67.8%
177
  69.1%
389
  69.7%
Between 18 and 65 years
70
  28.8%
19
  32.2%
78
  30.5%
167
  29.9%
>=65 years
1
   0.4%
0
   0.0%
1
   0.4%
2
   0.4%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 243 participants 59 participants 256 participants 558 participants
16  (15) 19  (16) 17  (14) 17  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 243 participants 59 participants 256 participants 558 participants
Female
200
  82.3%
47
  79.7%
210
  82.0%
457
  81.9%
Male
43
  17.7%
12
  20.3%
46
  18.0%
101
  18.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 243 participants 59 participants 256 participants 558 participants
243 59 256 558
1.Primary Outcome
Title Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice
Hide Description The primary efficacy endpoint was the proportion of primary subjects in the enrolled households who were lice free (no live lice, adults or nymphs), as assessed by the trained evaluator, 14 days after the last treatment (i.e., Day 14 for subjects who treated once and Day 21 for subjects who treated twice).
Time Frame Assessment were made 14 days following the final product treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Primary efficacy analysis was conducted using the Intent to Treat data obtained from primary subjects (i.e., youngest enrolled members of each household who had at least three live lice at the time of entry into the study). Subjects who were lice free 14 days post-treatment were considered successes and all other subjects were considered failures.
Arm/Group Title A - NatrOVA 1% - No Nit Combing Required B - NatrOVA 1% - Nit Combing Required C - NIX Applied Per Over the Counter (OTC) Instructions
Hide Arm/Group Description:
NatrOVA Creme Rinse (spinosad) 1% - no nit combing required
NatrOVA Creme Rinse (spinosad) 1% - nit comb regimen required
NIX Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC)Instructions for Use
Overall Number of Participants Analyzed 91 23 89
Measure Type: Number
Unit of Measure: participants
Success (no live lice present) 77 19 40
Failure (live lice present) 14 4 49
2.Secondary Outcome
Title Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions.
Hide Description To evaluate the safety of NatrOVA® 1% Creme Rinse based upon reported adverse events and observed skin/scalp reactions. Additional safety assessments included cutaneous/ocular irritation.
Time Frame Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments)
Hide Outcome Measure Data
Hide Analysis Population Description
558 subjects were randomized to treatment and 540 subjects used the study drug and returned for at least one post-baseline evaluation. At Day 0 the study drug was to be used within 24 hours. At Day 7 if subject presented with live lice they were provided a second treatment to be used within 24 hours. Thus subjects used 1 or 2 treatments.
Arm/Group Title A/B - NatrOVA 1% - With/Without Nit Combing C - NIX Applied Per Over the Counter (OTC) Instructions
Hide Arm/Group Description:
NatrOVA Creme Rinse (spinosad) 1% - With or without nit combing required
NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use
Overall Number of Participants Analyzed 294 246
Measure Type: Number
Unit of Measure: Incidents
Ear and labyrinth disorders - Ear pain 0 1
Eye disorders - Eye irritation 0 3
Eye disorders - pruritus 0 1
Eye disorders - Lacrimination increased 0 1
Eye disorders - Occular hyperaemia 12 15
Gastrointestinal disorders - Diarrhea 1 0
Gastrointestinal disorders - Stomach discomfort 1 0
Gastrointestinal disorders - Vomiting 1 0
Administration site conditions - discoloration 0 1
Administration site conditions - Dryness 1 0
Administration site conditions - Erythema 15 17
Administration site conditions - Irritation 5 6
Administration site conditions - Scab 0 1
General Disorder - Pyrexia 1 1
Infections and infestations - Cellulitis 0 1
Infections and infestations - Influenza 1 0
Infections and infestations - Nasopharyngitis 1 2
Infections and infestations - Otitis media 1 0
Infections - Pharyngitis streptococal 0 1
Infections - Upper respiratory tract infection 0 3
Injury - Skin laceration 1 0
Nervous system disorders - Headache 1 1
Nervous system disorders - Syncope 0 1
Respiratory -Chronic obstructive pulmonary disease 0 1
Respiratory - Cough 1 1
Respiratory disorders - pharyngolaryngeal pain 1 0
Skin disorders - Alopecia 1 0
Skin disorders - Dry skin 1 1
Skin disorders - Erythema 1 4
Time Frame Through out the study (7 months).
Adverse Event Reporting Description Verbatim descriptions of Adverse Events (AE) were assigned to system organ classes and terms via the MedDRA dictionary (v10.1). All randomized subjects who were presumed to have used the study medication at least once and who provided at least one post-baseline evaluation or reported at least one AE subsequent to using the study medication.
 
Arm/Group Title A/B - NatrOVA 1% - With/Without Nit Combing C - NIX Applied Per Over the Counter (OTC) Instructions
Hide Arm/Group Description NatrOVA Creme Rinse - 1% - With or without nit combing NIX Creme Rinse applied to Over the Counter (OTC) Instructions for Use
All-Cause Mortality
A/B - NatrOVA 1% - With/Without Nit Combing C - NIX Applied Per Over the Counter (OTC) Instructions
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
A/B - NatrOVA 1% - With/Without Nit Combing C - NIX Applied Per Over the Counter (OTC) Instructions
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/294 (0.00%)      2/246 (0.81%)    
General disorders     
Application Site Erythema  1 [1]  0/294 (0.00%)  0 1/246 (0.41%)  1
Infections and infestations     
Cellulitis  1 [2]  0/294 (0.00%)  0 1/246 (0.41%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.1
[1]
Subject randomized to NIX, applied the study medication twice. Day 8 the subject presented with application site erythema. Investigator reported event as a serious AE despite the fact that it did not meet the regulatory definition of a serious event.
[2]
Subject randomized to NIX, applied study medication twice. Day 14 presented with cellulitis. Subject was hospitalized, considered mild severity and unrelated to study medication. The event resolved with no sequelae. Subject didn't have Day 21 visit.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
A/B - NatrOVA 1% - With/Without Nit Combing C - NIX Applied Per Over the Counter (OTC) Instructions
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/294 (11.56%)      49/246 (19.92%)    
Eye disorders     
Eye irritation  1  0/294 (0.00%)  0 3/246 (1.22%)  3
Occular hyperaemia  1  12/294 (4.08%)  12 15/246 (6.10%)  15
General disorders     
Application site erythema  1  15/294 (5.10%)  15 16/246 (6.50%)  16
Application site irritation  1  5/294 (1.70%)  5 6/246 (2.44%)  6
Infections and infestations     
Nasopharyngitis  1  1/294 (0.34%)  1 2/246 (0.81%)  2
Upper respiratory tract infection  1  0/294 (0.00%)  0 3/246 (1.22%)  3
Skin and subcutaneous tissue disorders     
Erythema  1  1/294 (0.34%)  1 4/246 (1.63%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.1
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 of Quality and Regulatory
Organization: ParaPRO LLC
Phone: 317-810-6205
Responsible Party: ParaPRO LLC
ClinicalTrials.gov Identifier: NCT00545753     History of Changes
Other Study ID Numbers: SPN-301-07
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