Table 1.
Therapy | Study (Original Investigation) | Size | Duration (weeks) | Race, White (%) | Rosacea severity in treated groups | End-of-study efficacy | ||
---|---|---|---|---|---|---|---|---|
Moderate/Severe disease (%) | Baseline lesions (mean) | End-of-study lesions (mean) | IGA success (clear, almost clear, or 2-point IGA score improvement) (%) | |||||
Metronidazole | Nielsen [10] | 81 | 8 | NS | NS | 24.4 | 8.9 | 62.5a |
Dahl [13] | ||||||||
Metronidazole 0.75% | 72 | 12 | 100 | All rated as moderate or severe | 19 | 9 | 57a | |
Metronidazole 1% | 25 | 10 | 37a | |||||
Azelaic acid | Thiboutot et al. [16] | |||||||
Study 1 | 329 | 12 | 97 | 76/10 | 17.5 | 6.8 | 51 | |
Study 2 | 335 | 87 | 76/11 | 17.8 | 8.9 | 46 | ||
Draelos et al. [18] | ||||||||
2 parallel groups | 961 | 12 | 95.9 | 86.6/13.4 | 21.7 | 8.5 | 32 | |
Doxycycline 40 mg | Del Rosso et al. [23] | |||||||
Study 301 | 251 | 16 | 91 | 52.8/40.9 | 19.5 | 7.7 | 45.7 | |
Study 302 | 286 | 54.2/33.8 | 20.5 | 11 | 22.5 | |||
Ivermectin 1% | Stein Gold et al. [27] | |||||||
Study 1 | 683 | 12 | 96.2 | 82/18 | 30.9 | 7.4 | 38.4 | |
Study 2 | 688 | 95.3 | 75.9/24.1 | 32.9 | 8.2 | 40.1 | ||
Minocycline 1.5% | Stein Gold et al. [29] | |||||||
Study 1 | 751 | 12 | 95.8 | 88.7/11.3 | 28.5 | 10.93 | 52.1b | |
Study 2 | 771 | 97.3 | 85.1/14.9 | 30.0 | 11.46 | 49.1c | ||
E-BPO 5% | Bhatia et al. [33] | |||||||
Study 1 | 361 | 12 | 95.9 | 86.4/13.6 | 25.7 | 8.3 | 43.5 | |
Study 2 | 372 | 88 | 90.8/9.2 | 29.8 | 9.5 | 50.1 |
All studies included in this table were from properly powered and conducted individual randomized clinical trials and defined treatment success as being rating of clear, almost clear, or 2-point IGA score improvement, unless otherwise noted
E-BPO encapsulated benzoyl peroxide, IGA Investigator Global Assessment, NS not specified
aPercentages indicate “improved” or “much improved,” or “clear to mild rosacea.” “Clear” or “almost clear” terminology was not used
b,cThe IGA scale used in the studies only assessed the papulopustular component of rosacea and did not incorporate evaluation of facial erythema as part of the investigator’s static global assessment; this is an important distinction compared with IGA scales used in pivotal trials with other therapies