SIDE EFFECTS
During clinical trials, 550 acne patients were studied. Of these patients, 236 were treated with Aktipak. The most frequently reported adverse event considered at least possibly related was dry skin (7.6%) as compared to Vehicle (3.9%). Application site reactions (stinging, burning sensation, tingling, erythema) were reported in 2.5% of patients versus 1.3% of Vehicle patients. Blepharitis, pruritus and photosensitivity reactions were reported in < 2% of patients who used the dual pouch product.
Treatment Groups Summaries Number of Patients (%)
| COSTART Term |
Aktipak
N = 236 |
Aktipak Vehicle
N = 153 |
Benzamycin Topical Gel
N = 121 |
Benzamycin Topical Gel Vehicle
N = 40 |
| Dry Skin |
18 (7.6%) |
6 (3.9%) |
5 (5.0%) |
0 |
| APPLICATION SITE REACTION (stinging,erythema, and burning |
6 (2.5%) |
2 (1.3%) |
1 (0.8%) |
0 |
| BLEPHARITIS |
4 (1.7%) |
1 (0.7%) |
0 |
1 (2.5%) |
| PRURITUS |
4 (1.7%) |
2 (1.3%) |
3 (2.5%) |
0 |
| PHOTOSENSITIVITY REACTION (Sunburn, stinging with sun exposure) |
3 (1.3%) |
0 |
0 |
0 |
| PEELING |
1 (0.5%) |
1 (0.7%) |
0 |
0 |
