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 NCT00545168)

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

480 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 21 September 2007; the last follow up visit occurred on 8 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After admission to the study, subjects could have withdrawn at any time for any reason such as they no longer met the eligibility criteria, personal reasons, etc.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 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
Overall Study STARTED	203	63	214
Overall Study COMPLETED	187	58	193
Overall Study NOT COMPLETED	16	5	21

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Lost to Follow-up	5	5	5
Overall Study Withdrawal by Subject	9	0	13
Overall Study Protocol Violation	1	0	1
Overall Study Visit for Day 21 was not done in error	1	0	2

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 n=203 Participants NatrOVA Creme Rinse (spinosad) 1% - no nit combing required Spinosad	B - NatrOVA 1% - Nit Combing Required n=63 Participants NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required	C - NIX n=214 Participants Nix Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC) Instructions for Use	Total n=480 Participants Total of all reporting groups
Age, Categorical <=18 years	147 Participants n=5 Participants	46 Participants n=7 Participants	147 Participants n=5 Participants	340 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	56 Participants n=5 Participants	17 Participants n=7 Participants	64 Participants n=5 Participants	137 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants
Age Continuous	15 years STANDARD_DEVIATION 14 • n=5 Participants	14 years STANDARD_DEVIATION 13 • n=7 Participants	16 years STANDARD_DEVIATION 15 • n=5 Participants	16 years STANDARD_DEVIATION 14 • n=4 Participants
Sex: Female, Male Female	166 Participants n=5 Participants	48 Participants n=7 Participants	185 Participants n=5 Participants	399 Participants n=4 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants	81 Participants n=4 Participants
Region of Enrollment United States	203 participants n=5 Participants	63 participants n=7 Participants	214 participants n=5 Participants	480 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/B - NatrOVA 1% - With/Without Nit Combing n=83 Participants NatrOVA Creme Rinse (spinosad) 1% - With or without nit combing required	C - NIX n=21 Participants Nix Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC) Instructions for Use	C - NIX n=84 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)	72 participants	17 participants	36 participants
Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice Failure (live lice present)	11 participants	4 participants	48 participants

SECONDARY outcome

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

Population: 480 subjects were randomized to treatment and 469 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. 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/B - NatrOVA 1% - With/Without Nit Combing n=258 Participants NatrOVA Creme Rinse (spinosad) 1% - With or without nit combing required	C - NIX n=211 Participants Nix Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC) Instructions for Use	C - NIX 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. Ear and labyrinth disorders - Ear pain	1 Incidents	0 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	1 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Gastrointestinal disorders - Diarrhea	0 Incidents	2 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Gastroesophageal reflux disease	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 - Nausea	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 - Erythema	2 Incidents	14 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Administration site conditions - Exfoliation	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 - Irritation	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 - Ear infection	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 -Gastroenteritis viral	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 - Nasopharyngitis	1 Incidents	0 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	1 Incidents	1 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Musculoskeletal disorder - Fibromyalgia	0 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 - Dizziness	1 Incidents	0 Incidents	—
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Pregnancy	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	—

Adverse Events

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

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

C - NIX

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	A/B - NatrOVA 1% - With/Without Nit Combing n=258 participants at risk NatrOVA Creme Rinse (spinosad) 1% - With or without nit combing required	C - NIX n=211 participants at risk Nix Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC) Instructions for Use
Gastrointestinal disorders Gastrointestinal Viral	0.00% 0/258 • Through out the study (7 months). Verbatim descriptions of AEs were assigned to system organ classes and preferred terms using 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.	0.47% 1/211 • Number of events 1 • Through out the study (7 months). Verbatim descriptions of AEs were assigned to system organ classes and preferred terms using 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=258 participants at risk NatrOVA Creme Rinse (spinosad) 1% - With or without nit combing required	C - NIX n=211 participants at risk Nix Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC) Instructions for Use
General disorders Application site erythema	0.78% 2/258 • Number of events 2 • Through out the study (7 months). Verbatim descriptions of AEs were assigned to system organ classes and preferred terms using 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.	6.6% 14/211 • Number of events 14 • Through out the study (7 months). Verbatim descriptions of AEs were assigned to system organ classes and preferred terms using 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.
Gastrointestinal disorders Diarrhea	0.00% 0/258 • Through out the study (7 months). Verbatim descriptions of AEs were assigned to system organ classes and preferred terms using 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.	0.95% 2/211 • Number of events 2 • Through out the study (7 months). Verbatim descriptions of AEs were assigned to system organ classes and preferred terms using 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, 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