| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00713609 | Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne | PHASE2 | COMPLETED | 591 | — | — | Jun 1, 2008 | Mar 1, 2009 | Mar 6, 2017 | 16 | United States |
The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts \[only post-Baseline\]) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).
An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Benzoyl peroxide/clindamycin gel + tazarotene cream |
| 2 | ACTIVE_COMPARATOR | Benzoyl peroxide/clindamycin gel + vehicle cream |
| 3 | ACTIVE_COMPARATOR | Benzoyl peroxide gel + tazarotene cream |
| 4 | ACTIVE_COMPARATOR | Clindamycin gel + tazarotene cream |
| 5 | ACTIVE_COMPARATOR | Vehicle gel+ tazarotene cream |
| 6 | PLACEBO_COMPARATOR | Vehicle gel + vehicle cream |
| Name | Type | Description |
|---|---|---|
| Benzoyl peroxide gel | DRUG | 5% benzoyl peroxide in a gel applied topically once a day |
| Clindamycin gel | DRUG | 1% clindamycin phosphate applied topically once a day |
| Tazarotene cream | DRUG | 0.1 % tazarotene in a cream applied topically once a day |
| Vehicle gel | DRUG | Vehicle gel is an identical gel without the active ingredients |
| Vehicle cream | DRUG | Vehicle cream is an identical cream without the active ingredients |
Inclusion Criteria: * Inclusion Criteria: Subjects must be males or females 12 to 45 years of age. * Subjects must have acne on their face. * Female subjects of childbearing potential must have a negative pregnancy test. If sexually active, one medically acceptable forms of contraception must be pr...