Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BGC20-0582 · 1 trial · 2 indications
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...
BGC20-0582 is an investigational small molecule being developed as a topical gel treatment for Pediculus humanus capitis, commonly known as head lice infestation. It is intended for use in patients as young as 2 years old. The drug is currently in clinical development and has not been approved by regulatory authorities.
BGC20-0582 is being developed by Boston Scientific Corporation, a medical device and pharmaceutical company traded on the New York Stock Exchange under the ticker symbol BSX. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational head lice treatment.
BGC20-0582 is in Phase 2 clinical development. A Phase 2 trial evaluating the drug as a lice treatment gel has been completed. The drug remains investigational and is not yet approved for commercial use. Further clinical development would be required before any regulatory submission.
BGC20-0582 has one completed clinical trial registered as NCT00528021, titled 'A Study Evaluating the Safety and Efficacy of BGC20-0582 Lice Treatment Gel for Head Lice Infestation.' This Phase 2 study enrolled 230 participants in the United States and was randomized, double-blind, and placebo-controlled.
BGC20-0582 is a small molecule formulated as a topical gel. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being evaluated for its ability to treat head lice infestation when applied directly to the affected area.