Pediculosis Capitis
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of Licefreee Spray in eradicating head lice as compared to Nix, both are available over-the-counter lice treatments.
Detailed description
Head lice is a worldwide problem. Many treatments for lice appear to be losing their effectiveness; therefore products are needed that safely and effectively eradicate lice.
Interventions
DRUGLicefreee Spray
Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
DRUG1% permethrin creme rinse
Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
Sponsors
South Florida Family Health and Research Centers
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Must be 4 years of age or older * Must have an active head lice infestation of at least 10 lice and viable nits * Agree not used any other pediculicides or medicated products during the study * Agree not to use a nit comb during the study * Must have a single place of residence
Exclusion criteria
* Used any form of head lice treatment, prescription, OTC or home remedy for at least four weeks prior to their visit * Used topical medication of any kind on the hair for a period of 48 hours prior to visit * Individuals receiving systemic, topical drugs or medications which may interfere with the study results * Has a history of allergy or hypersensitivity to ragweed or any ingredient in either test products * Individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigator, will interfere with the evaluation * Females who are pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion Within Each Treatment Group of Subjects Who Have no Live Lice | 15 days | No live lice 15 days following initial treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 15 days | Number of participants with adverse events |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Licefreee Spray Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present. | 21 |
| Nix Creme Rinse, 1% Permethrin 1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present. | 21 |
| Total | 42 |
Baseline characteristics
| Characteristic | Licefreee Spray | Nix Creme Rinse, 1% Permethrin | Total |
|---|---|---|---|
| Age, Continuous | 15.57 years | 14.76 years | 15.17 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 20 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 1 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hair Curliness Curly | 1 participants | 5 participants | 6 participants |
| Hair Curliness Straight | 10 participants | 8 participants | 18 participants |
| Hair Curliness Wavy | 10 participants | 8 participants | 18 participants |
| Hair Length Extra long | 5 participants | 3 participants | 8 participants |
| Hair Length Long | 7 participants | 6 participants | 13 participants |
| Hair Length Medium | 7 participants | 11 participants | 18 participants |
| Hair Length Short | 2 participants | 1 participants | 3 participants |
| Hair Texture Average | 10 participants | 10 participants | 20 participants |
| Hair Texture Coarse | 3 participants | 7 participants | 10 participants |
| Hair Texture Fine | 8 participants | 4 participants | 12 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 19 Participants | 37 Participants |
| Region of Enrollment United States | 21 participants | 21 participants | 42 participants |
| Sex: Female, Male Female | 18 Participants | 20 Participants | 38 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
The Proportion Within Each Treatment Group of Subjects Who Have no Live Lice
No live lice 15 days following initial treatment
Time frame: 15 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Licefreee Spray | The Proportion Within Each Treatment Group of Subjects Who Have no Live Lice | 17 participants |
| Nix Creme Rinse, 1% Permethrin | The Proportion Within Each Treatment Group of Subjects Who Have no Live Lice | 9 participants |
Secondary
Adverse Events
Number of participants with adverse events
Time frame: 15 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Licefreee Spray | Adverse Events | 0 participants |
| Nix Creme Rinse, 1% Permethrin | Adverse Events | 0 participants |