Head Lice, Pediculus Humanus Capitis
Conditions
Keywords
Head Lice, Lice Infestation, Pediculosis, Pediculosis Capitis
Brief summary
The main purpose of this study is to investigate the safety and efficacy of an investigational treatment for head lice infestation against a placebo.
Detailed description
The main purpose of this study is to investigate the safety and efficacy of an investigational treatment for head lice infestation against a placebo.
Interventions
DRUGPlacebo
Vehicle Only
DRUGBGC20-0582
BGC20-0582 is a topical gel formulation of a naturally derived product. Subjects are treated either once (day 1) or twice (day 1 and 7) with either placebo or BGC20-0582 at one of the three concentrations. Following application of the BGC20-0582 lice treatment gel of placebo the product is rinsed from the subjects hair.
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. The subject and/or his/her parent/legal guardian have provided written informed consent, and, if appropriate, the child has provided assent. 2. Male or female subjects who are between the ages of 2 years (24 months) and 70 years old when consent is signed. 3. Infestation with head lice as demonstrated by the presence of live lice prior to first treatment. 4. Willing and able to attend all study visits as scheduled. 5. Females of childbearing potential must have a negative urine pregnancy test at screening and before receiving a second treatment, if necessary.
Exclusion criteria
1. Subject and/or legal guardian has not signed informed consent. 2. Subject was treated for pediculosis within 2 weeks prior to the screening evaluation. 3. Subject with an infestation of body lice or pubic lice. 4. Subject is suffering from a condition likely to require medical attention, including administration of oral or systemic antibiotics, oral or systemic corticosteroids, or any other treatment, which in the opinion of the investigator and visiting physician could influence the results of the study. 5. Subject with other diagnoses which, in the opinion of the investigator, would interfere with efficacy or safety assessments or would preclude study participation. 6. Subject with very short (shaved) hair. 7. Subject who will not be available for follow up visits. 8. Subject has been treated with a systemic antibiotic within the previous two weeks before screening. 9. Subject has been previously enrolled in any clinical study within the past 30 days; subject may not participate in another study while participating in this study. 10. Subject with history of allergy/sensitivity to active ingredient or related products; or any ingredients commonly included in hair products such as shampoos, hair conditioners, or styling aids. 11. Pregnant and/or nursing females.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Cure | Day 15 or 22 | Count of participants with No live lice |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 2.5% BGC20-0582 | 59 |
| 10% BGC20-0582 | 59 |
| 12.5% BGC20-0582 | 56 |
| Vehicle | 56 |
| Total | 230 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 17 | 13 | 7 | 9 |
Baseline characteristics
| Characteristic | 10% BGC20-0582 | 12.5% BGC20-0582 | 2.5% BGC20-0582 | Vehicle | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 56 Participants | 55 Participants | 55 Participants | 55 Participants | 221 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 1 Participants | 4 Participants | 1 Participants | 9 Participants |
| Age, Continuous | 13.5 years STANDARD_DEVIATION 12.1 | 13 years STANDARD_DEVIATION 10.2 | 12.3 years STANDARD_DEVIATION 11.5 | 12.3 years STANDARD_DEVIATION 8.8 | 12.8 years STANDARD_DEVIATION 10.7 |
| Region of Enrollment United States | 59 participants | 56 participants | 59 participants | 56 participants | 230 participants |
| Sex: Female, Male Female | 54 Participants | 49 Participants | 54 Participants | 49 Participants | 206 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 5 Participants | 7 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 59 | 10 / 59 | 16 / 56 | 11 / 56 |
| serious Total, serious adverse events | 0 / 59 | 0 / 59 | 0 / 56 | 0 / 56 |
Outcome results
Primary
Clinical Cure
Count of participants with No live lice
Time frame: Day 15 or 22
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2.5% BGC20-0582 | Clinical Cure | 30 Participants |
| 10% BGC20-0582 | Clinical Cure | 28 Participants |
| 12.5% BGC20-0582 | Clinical Cure | 35 Participants |
| Vehicle | Clinical Cure | 32 Participants |