explored in Phase II before the QD regimen was confirmed for the Phase III program. Consequently, a total of 2,047 subjects with PPR were exposed to the to-be-marketed formulation and regimen: ivermectin 1% QD.’ Only studies in which at least 1 subject was treated with the formulation proposed for registration contribute data to the two tables below Tables 8 and 9. 8. Exposure to Soolantra and comparators in clinical studies. Study type/ Controlled studies Total Sool Indication studies Sool Vehicle Other Other Sool iver active cream cream Clinical 17 17 pharmacology Indication 1 Pivotal 909 461 0 418 0 909 Other 731 206 146 532 484 1215 Subtotal 1640 667 146 950 484 2124 Indication 1 TOTAL 1640 667 146 950 501 2141 Table 9. Exposure to Soolantra in clinical studies according to dose and duration. Study type/ Proposed dose Other dose Indication 3 mo. 6 mo. 12 Any 3 mo. 6 mo. 12 Any ≥ ≥ ≥ ≥ ≥ ≥ mo. dur’n mo. dur’n Clinical 17 0 pharmacology Indication 1 1042 Active-controlled 839 784 717 14394 97 Uncontrolled 4843 Subtotal 839 784 717 2027 97 Indication 1 839 784 717 2044 97
explored in Phase II before the QD regimen was confirmed for the Phase III program. Consequently, a total of 2,047 subjects with PPR were exposed to the to-be-marketed formulation and regimen: ivermectin 1% QD.’ Only studies in which at least 1 subject was treated with the formulation proposed for registration contribute data to the two tables below Tables 8 and 9. 8. Exposure to Soolantra and comparators in clinical studies. Study type/ Indication Controlled studies studies Total Sool Sool Vehicle Other iver cream Other active cream Sool Clinical pharmacology 17 17 Indication 1 Pivotal 909 461 0 418 0 909 Other 731 206 146 532 484 1215 Subtotal Indication 1 1640 667 146 950 484 2124 TOTAL 1640 667 146 950 501 2141 Table 9. Exposure to Soolantra in clinical studies according to dose and duration. Study type/ Indication Proposed dose Other dose ≥ 3 mo. ≥ 6 mo. ≥ 12 mo. Any dur’n ≥ 3 mo. ≥ 6 mo. ≥ 12 mo. Any dur’n Clinical pharmacology 17 0 Indication 1 1042 Active-controlled 839 784 717 14394 97 Uncontrolled 4843 Subtotal Indication 1 839 784 717 2027 97 839 784 717 2044 97
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