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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01445301 | Study STF115287, a Clinical Confirmation Study of GSK2585823 in the Treatment of Acne Vulgaris in Japanese Subjects | PHASE3 | COMPLETED | 800 | — | — | Sep 27, 2011 | Aug 2, 2012 | Apr 27, 2018 | 26 | Japan |
| NCT01527123 | A Study to Evaluate the Pharmacokinetics of Benzoic Acid and Hippuric Acid After Topical Administration of GSK2585823 in Japanese Subjects With Acne Vulgaris | PHASE1 | COMPLETED | 12 | — | — | Feb 28, 2012 | Jun 1, 2012 | Jul 26, 2017 | 1 | Japan |
| NCT01428466 | Japanese Phase 1 Study of GSK2585823 | PHASE1 | COMPLETED | 20 | — | — | Nov 18, 2010 | Feb 15, 2011 | Aug 4, 2017 | 1 | Japan |
The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was 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 comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from post-randomization value at Week 12.
Blood PK sampling time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9,12hours post-dose (Day 1 and Day 8). Parameters: Maximum observed concentration(Cmax),Time of occurrence of Cmax (tmax), Area under the concentration-time curve from time zero (pre-dose) extrapolated to last time (AUC0-last), Area under the concentration-time curve from time zero (pre-dose) to 12 hours of quantifiable concentration within a subject across all treatments (AUC0-12) and Terminal phase half-life (t1/2,) for both benzoic acid and hippuric acid, after multiple application of GSK2585823, if calculable
| Arm | Type | Description |
|---|---|---|
| GSK2585823(CLDM 1%-BPO 3% gel) once daily | 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. |
| GSK2585823(CLDM 1%-BPO 3% gel) twice daily | 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 twice daily in the morning and evening/bedtime. |
| CLDM 1% gel twice daily | ACTIVE_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 twice daily in the morning and evening/bedtime. |
| GSK2585823 | EXPERIMENTAL | External Preparation |
| Benzoic peroxide 3% | ACTIVE_COMPARATOR | external preparation |
| Benzoic peroxide 5% | ACTIVE_COMPARATOR | external preparation |
| Vehicle | PLACEBO_COMPARATOR | external preparation |
| Name | Type | Description |
|---|---|---|
| GSK2585823(CLDM 1%-BPO 3% gel) | DRUG | Topical gel in 1 g containing clindamycin 10 mg and benzoyl peroxide 30 mg |
| CLDM 1% gel twice daily | DRUG | Topical gel containing clindamycin 10 mg/1 g gel |
| GSK2585823 | DRUG | CLDM1%/BPO3% |
| Benzoyl peroxide 3% | DRUG | Benzoyl peroxide 3% |
| Benzoyl peroxide 5% | DRUG | Benzoyl peroxide 5% |
| Vehicle | OTHER | placebo |
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 non...