Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BPO · 1 trial · 1 indication
During each study visit, investigators/assessors evaluated acne severity of the participants' faces using the ISGA scale: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.
During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules \[small inflamed elevation of the skin that is filled with pus\], papules \[solid elevation of skin with no visible fluid\], nodules \[larger than papules with significant depth\]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin). Missing values were imputed using the last observation carried forward (LOCF) method.
During each study visit, trained study personnel at every investigational center assessed the non-inflammatory (open comedones \[blackheads\] and closed comedones \[whiteheads\]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin).
During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | clindamycin / benzoyl peroxide gel |
| 2 | ACTIVE_COMPARATOR | Clindamycin gel |
| 3 | ACTIVE_COMPARATOR | BPO gel |
| 4 | PLACEBO_COMPARATOR | vehicle gel |
| Name | Type | Description |
|---|---|---|
| clindamycin / benzoyl peroxide gel | DRUG | Once a day application to the face |
| clindamycin gel | DRUG | Once a day application to the face |
| BPO gel | DRUG | Once a day application to the face |
| vehicle gel | DRUG | Once a day application to the face |
Inclusion Criteria: * Be 12 to 45 years of age, inclusive, and in good general health. * Clinical diagnosis of acne vulgaris * Females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product. * H...
BPO is a small molecule drug being developed for the treatment of acne vulgaris, a common skin condition characterized by pimples and inflammation. It is currently in Phase 3 clinical development and is being studied in a randomized, double-blind, placebo-controlled trial.
BPO is a small molecule drug that targets acne vulgaris. It is being evaluated in a Phase 3 clinical trial for its efficacy and safety in treating this condition. The trial is biomarker-selected, meaning participants are chosen based on specific biological markers.
BPO is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in Phase 3 clinical development for the treatment of acne vulgaris.
BPO is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for the treatment of acne vulgaris in a completed Phase 3 trial.
BPO has been studied in one Phase 3 clinical trial with the identifier NCT00776919, titled "Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne." This trial enrolled 1,315 participants with acne vulgaris and was conducted in the United States, Belize, and Canada.
BPO is a drug being developed by GSK plc for the treatment of acne vulgaris. It is currently in Phase 3 clinical development and has been studied in a placebo-controlled trial. The drug is being evaluated for its efficacy and safety in treating this condition.