| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00776919 | Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne | PHASE3 | COMPLETED | 1,315 | — | — | Oct 1, 2008 | Sep 1, 2009 | Nov 23, 2016 | 24 | United States, Belize +1 |
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...