Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01907490 | Safety and PK Study of Ha44 Gel Under Maximal Use Conditions for Treatment of Head Lice Infestation | PHASE2 | COMPLETED | 38 | — | — | Mar 1, 2013 | Dec 1, 2013 | Apr 28, 2020 | - | — |
Safety and tolerability assessed by AEs. Number of subjects with reporting AEs.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Ha44 Gel 0.74%, topical solution, maximum feasible amount applied for 10 minutes |
| Name | Type | Description |
|---|---|---|
| Ha44 Gel | DRUG | 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. |
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 ...