Pediculus Capitis Infestation
Conditions
Keywords
head lice
Brief 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 (Head lice).
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.
Interventions
DRUGSpinosad
10 minute topical application of product, followed by a complete rinse off.
DRUGPermethrin 1%
Topical application for 10 minutes, followed by a complete rinse off, followed by a nit combing regimen
Sponsors
ParaPRO LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subjects must have an active head lice infestation present at Day 0. 2. Subjects can be female or male, at least 6 months of age. 3. Subjects must be in good general health based on medical history. 4. Each subject must have an appropriately signed Informed Consent agreement. Subjects under the age of 12 must also provide written or oral assent. 5. The subject/caregiver must be able to read English or Spanish at a 7th grade level. 6. 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. 7. 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. 8. Subjects must agree not to cut or chemically treat their hair in the period between the initial treatment and the final visit. 9. Subjects/caregiver must demonstrate a clear understanding of his/her requirements for study participation and agree to comply with study instructions.
Exclusion criteria
1. Individuals with history of irritation or sensitivity to pediculicides or hair care products. 2. 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. 3. Individuals who require treatment with topical salicylic acid, topical corticosteroids, anthralin, vitamin D analogs, retinoids, immunosuppressants, topical hair growth formulations, and topical dandruff treatments. 4. Infested subjects who have been previously treated with a pediculicide within the 48 hours prior to the study. 5. Individuals with a condition or illness that, in the opinion of the Investigator, may compromise the objective of the protocol. 6. 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. 7. Individuals who have participated in a clinical trial within the past 30 days. 8. 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. 9. 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. 10. 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). 11. Sexually active females not using effective contraception. 12. Individuals who have a history of drug abuse in the past year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice | Assessment were made 14 days following the final product treatment | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. | Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (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. |
Countries
United States
Participant flow
Recruitment details
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
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.
Participants by arm
| Arm | Count |
|---|---|
| A - NatrOVA 1% - no Nit Combing NatrOVA Creme Rinse (spinosad) 1% - no nit combing required Spinosad | 203 |
| B - NatrOVA 1% - Nit Combing Required NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required | 63 |
| C - NIX Nix Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC) Instructions for Use | 214 |
| Total | 480 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 5 | 5 |
| Overall Study | Protocol Violation | 1 | 0 | 1 |
| Overall Study | Visit for Day 21 was not done in error | 1 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 9 | 0 | 13 |
Baseline characteristics
| Characteristic | B - NatrOVA 1% - Nit Combing Required | C - NIX | A - NatrOVA 1% - no Nit Combing | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 46 Participants | 147 Participants | 147 Participants | 340 Participants |
| Age, Categorical >=65 years | 0 Participants | 3 Participants | 0 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 64 Participants | 56 Participants | 137 Participants |
| Age Continuous | 14 years STANDARD_DEVIATION 13 | 16 years STANDARD_DEVIATION 15 | 15 years STANDARD_DEVIATION 14 | 16 years STANDARD_DEVIATION 14 |
| Region of Enrollment United States | 63 participants | 214 participants | 203 participants | 480 participants |
| Sex: Female, Male Female | 48 Participants | 185 Participants | 166 Participants | 399 Participants |
| Sex: Female, Male Male | 15 Participants | 29 Participants | 37 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 258 | 16 / 211 |
| serious Total, serious adverse events | 0 / 258 | 1 / 211 |
Outcome results
Primary
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/B - NatrOVA 1% - With/Without Nit Combing | Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice | Success (no live lice present) | 72 participants |
| A/B - NatrOVA 1% - With/Without Nit Combing | Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice | Failure (live lice present) | 11 participants |
| C - NIX | Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice | Success (no live lice present) | 17 participants |
| C - NIX | Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice | Failure (live lice present) | 4 participants |
| C - NIX | Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice | Success (no live lice present) | 36 participants |
| C - NIX | Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice | Failure (live lice present) | 48 participants |
Secondary
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)
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/B - NatrOVA 1% - With/Without Nit Combing | Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. | Gastrointestinal disorders - Nausea | 0 Incidents |
| A/B - NatrOVA 1% - With/Without Nit Combing | 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 |
| A/B - NatrOVA 1% - With/Without Nit Combing | 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 |
| A/B - NatrOVA 1% - With/Without Nit Combing | Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. | Gastrointestinal disorders - Diarrhea | 0 Incidents |
| A/B - NatrOVA 1% - With/Without Nit Combing | Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. | Gastroesophageal reflux disease | 1 Incidents |
| A/B - NatrOVA 1% - With/Without Nit Combing | 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 |
| A/B - NatrOVA 1% - With/Without Nit Combing | 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 |
| A/B - NatrOVA 1% - With/Without Nit Combing | 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 |
| A/B - NatrOVA 1% - With/Without Nit Combing | 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 |
| A/B - NatrOVA 1% - With/Without Nit Combing | 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 |
| A/B - NatrOVA 1% - With/Without Nit Combing | 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 |
| A/B - NatrOVA 1% - With/Without Nit Combing | 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 |
| A/B - NatrOVA 1% - With/Without Nit Combing | Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. | Musculoskeletal disorder - Fibromyalgia | 0 Incidents |
| A/B - NatrOVA 1% - With/Without Nit Combing | 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 |
| A/B - NatrOVA 1% - With/Without Nit Combing | Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. | Pregnancy | 0 Incidents |
| A/B - NatrOVA 1% - With/Without Nit Combing | 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 |
| C - NIX | Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. | Respiratory -Chronic obstructive pulmonary disease | 1 Incidents |
| C - NIX | Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. | Gastrointestinal disorders - Nausea | 1 Incidents |
| C - NIX | Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. | Infections and infestations - Ear infection | 1 Incidents |
| C - NIX | 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 |
| C - NIX | Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. | Musculoskeletal disorder - Fibromyalgia | 1 Incidents |
| C - NIX | Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. | Eye disorders - Eye irritation | 1 Incidents |
| C - NIX | Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. | Infections and infestations -Gastroenteritis viral | 1 Incidents |
| C - NIX | Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. | Gastrointestinal disorders - Diarrhea | 2 Incidents |
| C - NIX | Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. | Pregnancy | 1 Incidents |
| C - NIX | Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. | Gastroesophageal reflux disease | 0 Incidents |
| C - NIX | Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. | Infections and infestations - Nasopharyngitis | 0 Incidents |
| C - NIX | Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. | Administration site conditions - Erythema | 14 Incidents |
| C - NIX | Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. | Nervous system disorders - Dizziness | 0 Incidents |
| C - NIX | Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. | Administration site conditions - Exfoliation | 0 Incidents |
| C - NIX | 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 |
| C - NIX | Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. | Administration site conditions - Irritation | 1 Incidents |