Table 2 A complete list of the EVRAAS study outcomes
Primary outcome | Secondary outcomes |
|---|---|
1. Evaluation of repigmentation of vitiligous lesions achieved after the administration of 1% simvastatin-acid sodium salt or 1% atorvastatin calcium salt ointments compared with vehicle ointment after a 12-week study period (change from baseline in repigmentation on BSA and VASI scale). | 1. Number of participants with treatment-related adverse events as assessed by CTCAE version 4.0 2. Percentage of patients who achieved particular response rate in each arm assessed as a relative reduction in lesional skin area as follows: none, 0%; poor, 1–25%; moderate, 26–50%; good, 51–75%; excellent, > 75% 3. Percentage of patients who achieved particular response rate in each arm assessed as a relative reduction in BSA scale as follows: none, 0%; poor, 1–25%; moderate, 26–50%; good, 51–75%; excellent, > 75% 4. Percentage of patients who achieved particular response rate in each arm assessed as a relative reduction in VASI scale as follows: none, 0%; poor, 1–25%; moderate, 26–50%; good, 51–75%; excellent, > 75% 5. Comparison of simvastatin and atorvastatin efficacy between study participants 6. The association between disease duration and repigmentation rate in study arms 7. The association between estimated daily ointment use (grams per square centimeter of skin) and repigmentation rate in study arms |