Table 6.
Analysis of primary efficacy endpoints by Fitzpatrick skin type in the intent-to-treat population: Twelve-week-percent improvement from Baseline in EGSS and mean lesion counts
|
FITZPATRICK SKIN TYPE |
TREATMENT |
NUMBER OF PATIENTS |
EGGS SUCCESSa |
NONINFLAMMATORY LESIONS |
INFLAMMATORY LESIONS |
TOTAL LESIONS |
|---|---|---|---|---|---|---|
| I | CLIN/RA | N=47 | 16 (34.0)b | 50.4 ± 44.9c | 67.1 ± 24.5 | 58.4 ± 31.0 |
| Clin | N=47 | 16 (34.0) | 47.8 ± 32.7 | 54.2 ± 35.7 | 51.1 ± 28.9 | |
| P valued | 0.771 | 0.938 | 0.079 | 0.436 | ||
| II | CLIN/RA | N=214 | 66 (30.8) | 49.1 ± 36.6 | 56.7 ± 37.0 | 52.3 ±32.1 |
| Clin | N=214 | 64 (29.9) | 36.9 ± 44.9 | 49.1 ± 42.1 | 42.2 ± 36.4 | |
| P value | 0.994 | 0.010 | 0.170 | 0.015 | ||
| III | CLIN/RA | N=341 | 130 (38.1) | 48.8 ± 37.2 | 59.0 ± 38.8 | 53.2 ± 32.2 |
| Clin | N=339 | 104 (30.7) | 44.9 ± 36.4 | 56.1 ± 35.4 | 49.8 ± 30.6 | |
| P value | 0.031 | 0.118 | 0.173 | 0.087 | ||
| IV | CLIN/RA | N=231 | 96 (41.6) | 52.5 ± 34.6 | 63.0 ± 34.2 | 57.1 ± 30.8 |
| Clin | N=230 | 78 (33.9) | 40.6 ± 39.3 | 55.9 ± 39.3 | 46.8 ± 34.5 | |
| P value | 0.145 | 0.001 | 0.101 | 0.003 | ||
| V | CLIN/RA | N=106 | 42 (39.6) | 50.7 ± 41.9 | 65.6 ± 30.3 | 56.8 ± 31.4 |
| Clin | N=103 | 34 (33.0) | 36.8 ± 34.4 | 59.1 ± 30.5 | 45.6 ± 29.5 | |
| P value | 0.370 | 0.004 | 0.076 | 0.004 | ||
| VI | CLIN/RA | N=69 | 31 (44.9) | 46.9 ± 33.7 | 64.7 ± 34.6 | 53.0 ± 30.5 |
| Clin | N=69 | 22 (31.9) | 41.3 ±34.3 | 56.2 ± 43.5 | 46.5 ± 34.0 | |
| P value | 0.045 | 0.174 | 0.154 | 0.147 |
- EGSS
- evaluator's global severity score
- CLIN/RA gel
- clindamycin phosphate 1.2% tretinoin 0.025%
- Clin
- clindamycin gel
a
EGSS success was defined as clear or almost clear, or a 2-grade improvement from baseline.
b
Number of subjects (percent success)
c
Percent ± standard deviation
d
P values are based on a 2-sided 5% test of the Cochran-Mantel-Haenszel Row Mean Score Statistic, adjusting for investigational center.