Head Lice Infestation
Conditions
Keywords
Topical treatment of Head Lice Infestation
Brief summary
The purpose of the study is to evaluate the safety and tolerability of a single application of Ha44 Gel 0.74% w/v for the treatment of head lice under maximal use conditions. Secondary objective is to evaluate pharmacokinetics of Ha44 and benzyl alcohol (contained in Ha44 vehicle) under maximal use conditions.
Detailed description
This is an open-label safety and pharmacokinetic (PK) study involving a single application of Ha44 Gel 0.74% administered under maximal use conditions. All participants must have an active head lice infestation (at least 3 live lice) and be 6 months to 17 years of age. The study will enroll approximately 36 pediatric subjects between the ages of 6 months and 17 years. Pediatric PK samples will be collected at 0 (predose), 30 and 60 mins and 2 and 8 hrs time points. More than one household member with an active lice infestation may participate in the study. Eligible subjects will be consented and screened for study eligibility on Day 0 (Visit 1). All subjects will return to the study site for three follow-up clinic visits at Days 1, 7 and 14. The maximum study duration for a subject is 16 days.
Interventions
DRUGHa44 Gel
Eligible subjects will be treated at the study site on Day 0 with a single application of the maximum feasible amount of Ha44 Gel, to ensure saturation of the scalp and hair.
Sponsors
Accelovance
Target Health Inc.
Dr. Reddy's Laboratories Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female 2. 6 months to 17 years of age 3. Be in good health, as determined by medical history and physical examination 4. Has an active head lice infestation at screening as determined by an experienced evaluator. An active infestation is defined as the presence of at least 3 live lice. 5. Female subjects must be: * Of non-childbearing potential (no history of menstrual periods, post-hysterectomy, or post-menopausal for at least 2 years) OR, * If of childbearing potential, must have a negative urine pregnancy test prior to treatment and agree to use a highly effective method of contraception from Day 0 through the Day 14 visit. Acceptable methods of contraception include abstinence, vasectomized partner, tubal ligation, combined oral hormonal contraceptive, contraceptive injection, contraceptive patch, or IUD. If a hormonal contraception is the only method, the subject must have been on a stable dose for at least 3 months. 6. The parent/guardian agrees to allow serial blood samples collected from subject for PK analysis during study. 7. Has signed an informed consent and/or assent form (ICF).
Exclusion criteria
1. Has a condition or illness that, in the opinion of the Investigator, may interfere with the study results. 2. Has current dermatological disease or inflammation on the face, scalp, ears, neck or back, including eczema, atopic dermatitis, alopecia, psoriasis or any other chronic skin disease that, in the opinion of the Investigator, would interfere with the safety or PK evaluation. 3. Had a prior reaction to products containing piperonyl butoxide, pyrethrin, or pyrethrum extract. 4. Has been using hormonal contraception for less than 3 months. 5. Is pregnant or currently nursing. 6. Receiving systemic or topical medication, which in the opinion of the Investigator, may interfere with the study results. 7. Has received an investigational agent within 30 days prior to Day 0.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of the Subjects With AEs. | 3 months | Safety and tolerability assessed by AEs. Number of subjects with reporting AEs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pk Parameters: Cmax | 0 to 8 hours | Maximum concentration of Ha44 (Cmax) |
| PK Parameters: Tmax | 0-8 hours | Time to maximum concentration of Ha44 (Tmax) |
| PK Parameters: AUC(0-8) | 0-8 hours | Area under the concentration-time curve of Ha44 (AUC 0-8) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ha44 Gel 0.74% w/w Ha44 Gel 0.74% w/w Open label, one arm | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | Ha44 Gel 0.74% w/w |
|---|---|
| Age, Customized 12 months- <2 years | 9 participants |
| Age, Customized 2 years - <3 years | 11 participants |
| Age, Customized 3years-<18 years | 10 participants |
| Age, Customized 6months-<12 months | 8 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 38 |
| other Total, other adverse events | 2 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
Primary
Number of the Subjects With AEs.
Safety and tolerability assessed by AEs. Number of subjects with reporting AEs.
Time frame: 3 months
Population: paediatric population, children between ages 6 months to \<18 years.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ha44 Gel 0.74% w/w | Number of the Subjects With AEs. | 8 participants |
Secondary
PK Parameters: AUC(0-8)
Area under the concentration-time curve of Ha44 (AUC 0-8)
Time frame: 0-8 hours
Population: PK Population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ha44 Gel 0.74% w/w | PK Parameters: AUC(0-8) | 447.5 ng.h/mL |
Secondary
Pk Parameters: Cmax
Maximum concentration of Ha44 (Cmax)
Time frame: 0 to 8 hours
Population: Pharmacokinetic (PK) population included subjects who had sufficient concentration-time profiles for PK analyses.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ha44 Gel 0.74% w/w | Pk Parameters: Cmax | 141.4 ng/mL |
Secondary
PK Parameters: Tmax
Time to maximum concentration of Ha44 (Tmax)
Time frame: 0-8 hours
Population: PK population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ha44 Gel 0.74% w/w | PK Parameters: Tmax | 0.8 hours |