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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01771822 | Ibuprofen 5% Topical Gel CIPT | PHASE1 | COMPLETED | 50 | — | — | Jan 1, 2013 | Feb 1, 2013 | Feb 28, 2013 | 1 | United States |
| NCT01787448 | RIPT of Ibuprofen Topical Gel | PHASE1 | COMPLETED | 234 | — | — | Jan 1, 2013 | Feb 1, 2013 | Feb 28, 2013 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Ibuprofen 5% topical gel | EXPERIMENTAL | - |
| Topical gel vehicle | EXPERIMENTAL | - |
| Sodium lauryl sulfate 0.2% | ACTIVE_COMPARATOR | - |
| Sodium chloride solution 0.9% (saline) | SHAM_COMPARATOR | - |
| Sodium lauryl sulfate 0.1% | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Ibuprofen 5% topical gel | DRUG | 0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions |
| Topical gel vehicle | DRUG | 0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions |
| Sodium lauryl sulfate 0.2% | DRUG | 0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions |
| Sodium chloride solution 0.9% (saline) | DRUG | 0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions |
| Sodium lauryl sulfate 0.1% | DRUG | 0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application |
Inclusion Criteria: Healthy male and/or female subjects (to be confirmed by medical history) 18 years of age or older, female subjects of childbearing potential and males who are using an acceptable form of birth control, subjects who are free of any systemic or dermatologic disorder Exclusion Cri...