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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01400932 | Study STF115288, a Clinical Confirmation Study of GI148512 in the Treatment of Acne Vulgaris in Japanese Subjects | PHASE3 | COMPLETED | 360 | — | — | Jul 1, 2011 | Apr 1, 2012 | Aug 5, 2014 | 19 | Japan |
The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedos; diagnosis based on palpation) on the face at each study visit. An open comedo is an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedo is a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule is a small, raised, red, dome-shaped palpable lesion. A pustule is a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule may be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter.
| Arm | Type | Description |
|---|---|---|
| GI148512 (Benzoyl Peroxide 3% Gel) | EXPERIMENTAL | Subjects will apply in a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin). Also, the dose regimen will be once daily in the evening/bedtime. Comparison of 2 arms (GI148512 vs vehicle) |
| vehicle gel | PLACEBO_COMPARATOR | Subjects will apply in a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin). Also, the dose regimen will be once daily in the evening/bedtime. |
| Name | Type | Description |
|---|---|---|
| GI148512 | DRUG | GI148512, Topical gel in 1 g containing benzoyl peroxide 30 mg |
| vehicle gel | DRUG | Matching vehicle gel of GI148512, not containing active ingredient (benzoyl peroxide) |
Inclusion Criteria: * Male or female subjects 12 to 45 years (inclusive) of age in good general health. * Subjects must have both on the face: A) A minimum of 17 but not more than 60 inflammatory lesions (papules / pustules), including nasal lesions. And B) A minimum of 20 but not more than 150 n...