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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01367314 | Safety and Efficacy of Topical NVC-422 Gel in Impetigo | PHASE2 | COMPLETED | 129 | — | — | Aug 1, 2009 | Dec 1, 2010 | Jun 7, 2011 | 2 | Dominican Republic |
Sufficient resolution of signs and symptoms of infection of the target lesion such that no additional antimicrobial therapy is required to treat the impetigo as evidenced by the SIRS score of 0 each for exudate/pus, crusting and pain and 0 or 1 each for erythema/inflammation and itching for a clinical success or a SIRS score of 0 for exudate/pus but does not meet all the criteria for clinical success for a clinical improvement.
| Arm | Type | Description |
|---|---|---|
| NVC-422 Dermal Gel, 1.5% | EXPERIMENTAL | - |
| NVC-422 Dermal Gel, 0.5% | EXPERIMENTAL | - |
| NVC-422 Dermal Gel, 0.1% | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| NVC-422 | DRUG | Dermal Gel applied 3 times per day for 7 days |
Inclusion Criteria: * Subjects must be 2 - 12 years of age * Parents or Legal Guardians must sign a written informed consent document * Positive Gram stain of target lesion showing Gram-positive cocci; * Clinical diagnosis of primary non-bullous impetigo as per the protocol * Skin Infection Rating ...