CompletedNCT00545753Updated Oct 11, 2012Results posted

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

A Phase 3 interventional study of Spinosad and Spinosad in Pediculosis, sponsored by ParaPRO LLC. Completed at 6 sites in United States. Open to participants aged 6 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-11.

Sponsored by ParaPRO LLC · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 558
Allocation: Randomized
Ages: 6 Months and older
Sex: All

Study summary

A comparative safety and efficacy study of NatrOVA Creme Rinse - 1% versus NIX Creme Rinse, under actual use conditions in subjects 6 months of age or greater who are infested with Pediculosis capitis (human head lice).

Read the detailed description

This is a Phase 3 multi-site, randomized, evaluator/investigator-blinded, three-arm, parallel group study evaluating the safety and efficacy of NatrOVA Creme Rinse - 1% (with nit combing and without nit combing) versus NIX Creme Rinse in an "actual use" environment.

Conditions studied

Pediculosis

Browse trials for

Lice Infestations 58

Keywords

Human Head lice

Who can participate

Ages eligible: 6 Months and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Subjects must have an active head lice infestation present at Day 0.
Subjects can be female or male, at least 6 months of age.
Subjects must be in good general health based on medical history.
Each subject must have an appropriately signed Informed Consent agreement. Subjects under the age of 12 must also provide written or oral assent.
The subject/caregiver must be able to read English or Spanish at a 7th grade level.
The parent or guardian within a household must be willing to allow other household members to be screened for head lice. If other household members are found to have a head lice infestation, they should also be enrolled in the study.
Subjects must agree to not use any other form of lice treatment during the course of the study and must agree not to use any of the excluded concomitant medications.
Subjects must agree not to cut or chemically treat their hair in the period between the initial treatment and the final visit.
Subjects/caregiver must demonstrate a clear understanding of his/her requirements for study participation and agree to comply with study instructions.

Exclusion criteria

Exclusion Criteria:

Individuals with history of irritation or sensitivity to pediculicides or hair care products.
Individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigative personnel or Sponsor, will interfere with the evaluation.
Individuals who require treatment with topical salicylic acid, topical corticosteroids, anthralin, vitamin D analogs, retinoids, immunosuppressants, topical hair growth formulations, and topical dandruff treatments.
Infested subjects who have been previously treated with a pediculicide within the 48 hours prior to the study.
Individuals with a condition or illness that, in the opinion of the Investigator, may compromise the objective of the protocol.
Individuals receiving systemic or topical drugs or medications, including systemic antibiotics, which in the opinion of the investigative personnel or study monitor may interfere with the study results.
Individuals who have participated in a clinical trial within the past 30 days.
Individuals (or individuals from households) who, in the opinion of the Investigator, do not understand the requirements for study participation and/or may be likely to exhibit poor compliance.
Individuals with household members who are infested with lice but are unwilling or unable to enroll in the study or to use the standard course of lice treatment.
Females who are pregnant or nursing. Females of childbearing potential must have a negative urine pregnancy test prior to treatment at Day 0. If a household has a pregnant female with an active case of head lice, the entire household is excluded from participation. If the pregnant household member does not have lice, this individual must NOT be the caregiver (one who provides treatment to other household members).
Sexually active females not using effective contraception.
Individuals who have a history of drug abuse in the past year.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Care provider, Investigator, Outcomes assessor)
Enrollment: 558 participants (actual)

Study arms

Experimental
A - NatrOVA 1% - no nit combing
NatrOVA Creme Rinse (spinosad) 1% - no nit combing required
Drug: Spinosad
Experimental
B - NatrOVA 1% - nit combing required
NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required
Drug: Spinosad
Active comparator
C - NIX
NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use
Drug: Permethrin 1%

Interventions

DrugSpinosad
10 minute topical application product, following by a complete rinse off.
Also known as: Natroba (spinosad) Topical Suspension, 0.9%
DrugSpinosad
10 minute topical application followed by a complete rinse off, followed by a nit combing regimen
Also known as: Natroba (spinosad) Topical Suspension, 0.9%
DrugPermethrin 1%
Topical application for 10 minutes, followed by a complete rinse off, followed by a nit combing regimen
Also known as: NIX Creme Rinse

What researchers measure

Primary outcomes

Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice
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

Secondary outcomes

Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions.
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)

Results

Posted Oct 11, 2012

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.

Participant flow — Overall Study
Milestone	A - NatrOVA 1% - No Nit Combing Required	B - NatrOVA 1% - Nit Combing Required	C - NIX Applied Per Over the Counter (OTC) Instructions
Started	243	59	256
Completed	227	54	230
Not completed	16	5	26
Withdrew: Withdrawal by subject	0	1	10
Withdrew: Lost to follow-up	13	3	12
Withdrew: Protocol violation	3	1	4

Outcome measures

PrimaryEfficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice

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
Reported as:: Number · participants

Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice
participants	A - NatrOVA 1% - No Nit Combing Required	B - NatrOVA 1% - Nit Combing Required	C - NIX Applied Per Over the Counter (OTC) Instructions
Success (no live lice present)	77	19	40 (32.7% to 57.5%)
Failure (live lice present)	14	4	49

SecondaryEvaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions.

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)
Reported as:: Number · Incidents

Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions.
Incidents	A/B - NatrOVA 1% - With/Without Nit Combing	C - NIX Applied Per Over the Counter (OTC) Instructions
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

Adverse events

Collected over Through out the study (7 months).. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
A/B - NatrOVA 1% - With/Without Nit Combing	—	0/294 (0%)	34/294 (11.6%)
C - NIX Applied Per Over the Counter (OTC) Instructions	—	2/246 (0.8%)	49/246 (19.9%)

Most frequent serious events

Most frequent serious events
Event	A/B - NatrOVA 1% - With/Without Nit Combing	C - NIX Applied Per Over the Counter (OTC) Instructions
Application Site ErythemaGeneral disorders	0/294	1/246
CellulitisInfections and infestations	0/294	1/246

Most frequent other events

Most frequent other events
Event	A/B - NatrOVA 1% - With/Without Nit Combing	C - NIX Applied Per Over the Counter (OTC) Instructions
Application site erythemaGeneral disorders	15/294	16/246
Occular hyperaemiaEye disorders	12/294	15/246
Application site irritationGeneral disorders	5/294	6/246
ErythemaSkin and subcutaneous tissue disorders	1/294	4/246
Eye irritationEye disorders	0/294	3/246
Upper respiratory tract infectionInfections and infestations	0/294	3/246
NasopharyngitisInfections and infestations	1/294	2/246

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	A - NatrOVA 1% - No Nit Combing Required	B - NatrOVA 1% - Nit Combing Required	C - NIX Applied Per Over the Counter (OTC) Instructions	Total
<=18 years	172	40	177	389
Between 18 and 65 years	70	19	78	167
>=65 years	1	0	1	2

Age Continuous
Age Continuous(years)	A - NatrOVA 1% - No Nit Combing Required	B - NatrOVA 1% - Nit Combing Required	C - NIX Applied Per Over the Counter (OTC) Instructions	Total
Mean	16 ± 15	19 ± 16	17 ± 14	17 ± 15

Sex: Female, Male
Sex: Female, Male(Participants)	A - NatrOVA 1% - No Nit Combing Required	B - NatrOVA 1% - Nit Combing Required	C - NIX Applied Per Over the Counter (OTC) Instructions	Total
Female	200	47	210	457
Male	43	12	46	101

Region of Enrollment
Region of Enrollment(participants)	A - NatrOVA 1% - No Nit Combing Required	B - NatrOVA 1% - Nit Combing Required	C - NIX Applied Per Over the Counter (OTC) Instructions	Total
United States	243	59	256	558

Study locations

6 sites

Hill Top Research
Scottsdale, Arizona 85251, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas 71913, United States
Impact Clinical Trials
Beverly Hills, California 90211, United States
DMI Healthcare Group
Largo, Florida 33773, United States
Hill Top Research
Miamiville, Ohio 45147, United States
Haber Dermatology & Cosmetic Surgery
South Euclid, Ohio 44118, United States

Registry details

Key details

Study ID: NCT00545753
Lead sponsor: ParaPRO LLC
Responsible party: Sponsor
First posted: Oct 17, 2007
Start date: Sep 2007
Primary completion: Mar 2008
Completion: May 2008
Results posted: Oct 11, 2012
Last update: Oct 11, 2012

Study contacts

Bill Miller, MD

study director · Concentrics Research

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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