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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00528021 | A Study Evaluating the Safety and Efficacy of BGC20-0582 Lice Treatment Gel for Head Lice Infestation | PHASE2 | COMPLETED | 230 | — | — | Aug 1, 2007 | Jun 1, 2008 | Jun 28, 2022 | 1 | United States |
Count of participants with No live lice
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | Subjects are treated either once (day1) or twice (day 1 and 7) with either placebo or 2.5% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair. |
| 2 | ACTIVE_COMPARATOR | Subjects are treated either once (day1) or twice (day 1 and 7) with either placebo or 10% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair. |
| 3 | ACTIVE_COMPARATOR | Subjects are treated either once (day1) or twice (day 1 and 7) with either placebo or 12.5% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair. |
| 4 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Vehicle Only |
| BGC20-0582 | DRUG | 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. |
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...