Pediculosis
Conditions
Brief summary
Phase 2 study to assess the safety and effectiveness of a product to treat children and adults with head lice
Interventions
DRUGGroup A - Low-Dose Ha44 0.37% w/w
Low Dose Ha44 Gel applied to scalp and hair for 10 minutes
DRUGGroup B - High Dose Ha44 Gel 0.74% w/w
High Dose Ha44 Gel applied to scalp and hair for 10 minutes
Placebo- vehicle Ha44 Gel without active ingredient applied to scalp and hair for 10 minutes
Sponsors
Dr. Reddy's Laboratories Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 2 years of age or older * Body weight of at least 33 pounds * Has an active head lice infestation at Day 0. An active infection is defined as at least 3 live lice for the index subject and at least 1 live louse for the other household members * Belong to a household of no more than 6 members, except where additional household members are \< 2 years of age * Belong to a household with an eligible index subject between 2 and 12 years of age with active lice infestation * 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.
Exclusion criteria
* Had treatment for head lice within 14 days prior to Day 0 * Has a household member(s) who is infested with lice but is not willing or not eligible for enrollment * Has a condition or illness that, in the opinion of the Investigator, may interfere with the study results * Has an electrocardiographic abnormality, renal disease or impaired renal function, dermatological disease on the face, scalp, ears or neck, or active ophthalmological disease, moderate or severe scleral injection with conjunctival erythema or purulent discharge or allergic or perennial rhinitis requiring chronic treatment * Has been using hormonal contraception for less than 3 months or is pregnant or lactating * Has received systemic corticosteroids within 7 days prior to Day 0 or planned while on study * Receiving systemic or topical medication, which in the opinion of the Investigator, may interfere with the study results * Has received an investigational agent within 30 days prior to Day 0
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Who Are Lice Free at All Follow-up Visits (Day 1, 7 and 14) Through the Day 14 Visit | Follow up visit at days 1, 7 and 14 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of Ha44 Gel | From treatment to last visit of the study at 14 days | The number of subjects with Treatment emergent AEs (TEAEs) related to the study medication will be reported by treatment group. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low Dose Ha44 Gel Low-Dose Ha44 0.37% Gel, topically administered to hair and scalp for 10 minutes | 46 |
| High-Dose Ha44 High-Dose Ha44 0.74% Gel, topically administered to hair and scalp for 10 minutes | 49 |
| Vehicle Vehicle Gel without active ingredient of Ha44. | 47 |
| Total | 142 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 1 | 3 |
Baseline characteristics
| Characteristic | Low Dose Ha44 Gel | High-Dose Ha44 | Vehicle | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 38 Participants | 35 Participants | 30 Participants | 103 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 14 Participants | 17 Participants | 39 Participants |
| Age, Customized | 13.7 years STANDARD_DEVIATION 10.5 | 15.3 years STANDARD_DEVIATION 11.3 | 17.3 years STANDARD_DEVIATION 13.3 | 15.4 years STANDARD_DEVIATION 11.7 |
| Sex: Female, Male Female | 42 Participants | 42 Participants | 44 Participants | 128 Participants |
| Sex: Female, Male Male | 4 Participants | 7 Participants | 3 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 46 | 2 / 49 | 20 / 47 |
| serious Total, serious adverse events | 0 / 46 | 0 / 49 | 0 / 47 |
Outcome results
Primary
Number of Participants Who Are Lice Free at All Follow-up Visits (Day 1, 7 and 14) Through the Day 14 Visit
Time frame: Follow up visit at days 1, 7 and 14 days
Population: Intent to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low Dose Ha44 | Number of Participants Who Are Lice Free at All Follow-up Visits (Day 1, 7 and 14) Through the Day 14 Visit | 31 participants |
| Hig Dose Ha44 | Number of Participants Who Are Lice Free at All Follow-up Visits (Day 1, 7 and 14) Through the Day 14 Visit | 42 participants |
| Vehicle | Number of Participants Who Are Lice Free at All Follow-up Visits (Day 1, 7 and 14) Through the Day 14 Visit | 11 participants |
Comparison: Null hypothesis; 80% power and 0.025 two-sided level of significance for each pairwise active vs. vehicle comparisonp-value: <0.001Fisher Exact
Secondary
Safety and Tolerability of Ha44 Gel
The number of subjects with Treatment emergent AEs (TEAEs) related to the study medication will be reported by treatment group.
Time frame: From treatment to last visit of the study at 14 days
Population: All subjects who participated
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low Dose Ha44 | Safety and Tolerability of Ha44 Gel | 5 participants with treatment related AEs |
| Hig Dose Ha44 | Safety and Tolerability of Ha44 Gel | 8 participants with treatment related AEs |
| Vehicle | Safety and Tolerability of Ha44 Gel | 13 participants with treatment related AEs |