Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK2585823 · 3 trials · 1 indication
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...
GSK2585823 is an investigational small molecule being developed for the treatment of acne vulgaris. It is a topical medication studied in Japanese patients, including adolescents aged 12 years and older. The drug is not approved and remains in clinical development, with its most advanced trial being a Phase 3 study.
GSK2585823 is being developed by GSK plc, a global pharmaceutical company traded on the London Stock Exchange under the ticker GSK. The company has sponsored multiple clinical trials of this investigational acne vulgaris treatment in Japan.
GSK2585823 is in Phase 3 clinical development for acne vulgaris. The most advanced study, NCT01445301, is a Phase 3 clinical confirmation trial conducted in Japanese subjects. The drug is investigational and has not been approved by regulatory authorities.
GSK2585823 has been studied in three completed clinical trials in Japan: NCT01428466, a Phase 1 study in healthy volunteers; NCT01445301, a Phase 3 efficacy study in 800 patients with acne vulgaris; and NCT01527123, a Phase 1 pharmacokinetic study. All trials are completed.
GSK2585823 is a small molecule developed for topical treatment of acne vulgaris. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being evaluated for its ability to treat acne lesions in Japanese patients.