Local Tolerability of AN2728 Topical Ointment, 2% in ... - Anacor
Local Tolerability of AN2728 Topical Ointment, 2% in ... - Anacor
Local Tolerability of AN2728 Topical Ointment, 2% in ... - Anacor
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Study Design <strong>in</strong> Brief<br />
Objective:<br />
– To evaluate the safety and local tolerability <strong>of</strong> <strong>AN2728</strong> <strong>Topical</strong> <strong>O<strong>in</strong>tment</strong>,<br />
<strong>2%</strong> <strong>in</strong> sensitive sk<strong>in</strong> areas<br />
Design:<br />
– S<strong>in</strong>gle-center (Australia), randomized, double-bl<strong>in</strong>d, vehicle-controlled<br />
trial<br />
Intervention:<br />
– <strong>AN2728</strong> <strong>Topical</strong> <strong>O<strong>in</strong>tment</strong>, <strong>2%</strong> vs. Vehicle (3:1); BID x 21 days<br />
– Applied to 13 anatomic areas:<br />
• Bilateral elbows, knees, gro<strong>in</strong>s, axillae, and retroauricular areas<br />
• Gluteal cleft<br />
• External genitalia<br />
• Face/hairl<strong>in</strong>e<br />
Outcomes: Descriptive<br />
– Safety: Reported AEs, Safety labs, Vital signs<br />
– <strong>Local</strong> tolerability: burn<strong>in</strong>g/st<strong>in</strong>g<strong>in</strong>g, pruritus, erythema<br />
Population:<br />
– 32 healthy volunteers (16 men, 16 women), 18-55 years <strong>of</strong> age<br />
4
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