Trial Outcomes & Findings for Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice (NCT NCT00545753)

Last Updated: 2012-10-11

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

558 participants

Primary outcome timeframe

Assessment were made 14 days following the final product treatment

Results posted on

2012-10-11

Participant Flow

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.

After admission to the study, subjects could have withdrawn at any time for any reason such as they no longer met the eligibility criteria, personal reasons, etc.

Participant milestones

Participant milestones
Measure	A - NatrOVA 1% - No Nit Combing Required NatrOVA Creme Rinse (spinosad) 1% - no nit combing required	B - NatrOVA 1% - Nit Combing Required NatrOVA Creme Rinse (spinosad) 1% - nit comb regimen required	C - NIX Applied Per Over the Counter (OTC) Instructions NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use
Overall Study STARTED	243	59	256
Overall Study COMPLETED	227	54	230
Overall Study NOT COMPLETED	16	5	26

Reasons for withdrawal

Reasons for withdrawal
Measure	A - NatrOVA 1% - No Nit Combing Required NatrOVA Creme Rinse (spinosad) 1% - no nit combing required	B - NatrOVA 1% - Nit Combing Required NatrOVA Creme Rinse (spinosad) 1% - nit comb regimen required	C - NIX Applied Per Over the Counter (OTC) Instructions NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use
Overall Study Withdrawal by Subject	0	1	10
Overall Study Lost to Follow-up	13	3	12
Overall Study Protocol Violation	3	1	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A - NatrOVA 1% - No Nit Combing Required n=243 Participants NatrOVA Creme Rinse - 1% - no nit combing required	B - NatrOVA 1% - Nit Combing Required n=59 Participants NatrOVA Creme Rinse - 1% - nit comb regimen required	C - NIX Applied Per Over the Counter (OTC) Instructions n=256 Participants NIX Creme Rinse applied to Over the Counter (OTC) Instructions for Use	Total n=558 Participants Total of all reporting groups
Age, Categorical <=18 years	172 Participants n=5 Participants	40 Participants n=7 Participants	177 Participants n=5 Participants	389 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	70 Participants n=5 Participants	19 Participants n=7 Participants	78 Participants n=5 Participants	167 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Age Continuous	16 years STANDARD_DEVIATION 15 • n=5 Participants	19 years STANDARD_DEVIATION 16 • n=7 Participants	17 years STANDARD_DEVIATION 14 • n=5 Participants	17 years STANDARD_DEVIATION 15 • n=4 Participants
Sex: Female, Male Female	200 Participants n=5 Participants	47 Participants n=7 Participants	210 Participants n=5 Participants	457 Participants n=4 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	12 Participants n=7 Participants	46 Participants n=5 Participants	101 Participants n=4 Participants
Region of Enrollment United States	243 participants n=5 Participants	59 participants n=7 Participants	256 participants n=5 Participants	558 participants n=4 Participants

PRIMARY outcome

Timeframe: Assessment were made 14 days following the final product treatment

Population: 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.

Outcome measures

Outcome measures
Measure	A - NatrOVA 1% - No Nit Combing Required n=91 Participants NatrOVA Creme Rinse (spinosad) 1% - no nit combing required	B - NatrOVA 1% - Nit Combing Required n=23 Participants NatrOVA Creme Rinse (spinosad) 1% - nit comb regimen required	C - NIX Applied Per Over the Counter (OTC) Instructions n=89 Participants NIX Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC)Instructions for Use
Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice Success (no live lice present)	77 participants	19 participants	40 participants
Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice Failure (live lice present)	14 participants	4 participants	49 participants

SECONDARY outcome

Timeframe: Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	A - NatrOVA 1% - No Nit Combing Required n=294 Participants NatrOVA Creme Rinse (spinosad) 1% - no nit combing required	B - NatrOVA 1% - Nit Combing Required n=246 Participants NatrOVA Creme Rinse (spinosad) 1% - nit comb regimen required	C - NIX Applied Per Over the Counter (OTC) Instructions NIX Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC)Instructions for Use
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Skin disorders - Alopecia	1 Incidents	0 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Skin disorders - Dry skin	1 Incidents	1 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Skin disorders - Erythema	1 Incidents	4 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Infections and infestations - Nasopharyngitis	1 Incidents	2 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Ear and labyrinth disorders - Ear pain	0 Incidents	1 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Eye disorders - Eye irritation	0 Incidents	3 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Eye disorders - pruritus	0 Incidents	1 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Eye disorders - Lacrimination increased	0 Incidents	1 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Eye disorders - Occular hyperaemia	12 Incidents	15 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Gastrointestinal disorders - Diarrhea	1 Incidents	0 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Gastrointestinal disorders - Stomach discomfort	1 Incidents	0 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Gastrointestinal disorders - Vomiting	1 Incidents	0 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Administration site conditions - discoloration	0 Incidents	1 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Administration site conditions - Dryness	1 Incidents	0 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Administration site conditions - Erythema	15 Incidents	17 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Administration site conditions - Irritation	5 Incidents	6 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Administration site conditions - Scab	0 Incidents	1 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. General Disorder - Pyrexia	1 Incidents	1 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Infections and infestations - Cellulitis	0 Incidents	1 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Infections and infestations - Influenza	1 Incidents	0 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Infections and infestations - Otitis media	1 Incidents	0 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Infections - Pharyngitis streptococal	0 Incidents	1 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Infections - Upper respiratory tract infection	0 Incidents	3 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Injury - Skin laceration	1 Incidents	0 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Nervous system disorders - Headache	1 Incidents	1 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Nervous system disorders - Syncope	0 Incidents	1 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Respiratory -Chronic obstructive pulmonary disease	0 Incidents	1 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Respiratory - Cough	1 Incidents	1 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Respiratory disorders - pharyngolaryngeal pain	1 Incidents	0 Incidents	—

Adverse Events

A/B - NatrOVA 1% - With/Without Nit Combing

Serious events: 0 serious events

Other events: 34 other events

Deaths: 0 deaths

C - NIX Applied Per Over the Counter (OTC) Instructions

Serious events: 2 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	A/B - NatrOVA 1% - With/Without Nit Combing n=294 participants at risk NatrOVA Creme Rinse - 1% - With or without nit combing	C - NIX Applied Per Over the Counter (OTC) Instructions n=246 participants at risk NIX Creme Rinse applied to Over the Counter (OTC) Instructions for Use
General disorders Application Site Erythema	0.00% 0/294 • Through out the study (7 months). 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.	0.41% 1/246 • Number of events 1 • Through out the study (7 months). 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.
Infections and infestations Cellulitis	0.00% 0/294 • Through out the study (7 months). 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.	0.41% 1/246 • Number of events 1 • Through out the study (7 months). 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.

Other adverse events

Other adverse events
Measure	A/B - NatrOVA 1% - With/Without Nit Combing n=294 participants at risk NatrOVA Creme Rinse - 1% - With or without nit combing	C - NIX Applied Per Over the Counter (OTC) Instructions n=246 participants at risk NIX Creme Rinse applied to Over the Counter (OTC) Instructions for Use
Eye disorders Occular hyperaemia	4.1% 12/294 • Number of events 12 • Through out the study (7 months). 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.	6.1% 15/246 • Number of events 15 • Through out the study (7 months). 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.
General disorders Application site erythema	5.1% 15/294 • Number of events 15 • Through out the study (7 months). 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.	6.5% 16/246 • Number of events 16 • Through out the study (7 months). 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.
Eye disorders Eye irritation	0.00% 0/294 • Through out the study (7 months). 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.	1.2% 3/246 • Number of events 3 • Through out the study (7 months). 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.
General disorders Application site irritation	1.7% 5/294 • Number of events 5 • Through out the study (7 months). 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.	2.4% 6/246 • Number of events 6 • Through out the study (7 months). 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.
Infections and infestations Nasopharyngitis	0.34% 1/294 • Number of events 1 • Through out the study (7 months). 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.	0.81% 2/246 • Number of events 2 • Through out the study (7 months). 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.
Infections and infestations Upper respiratory tract infection	0.00% 0/294 • Through out the study (7 months). 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.	1.2% 3/246 • Number of events 3 • Through out the study (7 months). 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.
Skin and subcutaneous tissue disorders Erythema	0.34% 1/294 • Number of events 1 • Through out the study (7 months). 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.	1.6% 4/246 • Number of events 4 • Through out the study (7 months). 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.

Additional Information

Director of Quality and Regulatory

ParaPRO LLC

Phone: 317-810-6205

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place