Effect of Oral TXA on Buttock Bruising Post CCH Injections in Adult Females

Summary

This is an open-label, randomized, multiple dose IIR study to evaluate the effect of Lysteda™ on bruising following QWO™ injections to the buttocks in female subjects presenting with moderate to severe cellulite. Following determination of eligibility based on inclusion/exclusion assessment, the subjects will be randomized to either Cohort A, Cohort B, or Cohort C, based on order of enrollment. Each Cohort will receive 3 Qwo™ treatments spaced 21 days apart, with 1300 mg of Lysteda™ TID PO at one, two, or all three treatments of Qwo™. Cohort A will be given tranexamic acid at the first treatment, Cohort B at the first and second treatment, and Cohort C at all three treatments. All buttock CCH injections will follow the on-label injection protocol. Subjects will participate in the study for 65 days total, with an additional screening period of 14 days. There will be a total of 11 visits (Screening, Day 1, Day 4, Day 14, Day 22, Day 26, Day 36, Day 43, Day 47, Day 57, Day 65).

Timeline

Start

2022-04-22

Primary completion

2022-09-01

Completion

2022-10-01

Drugs

Indications

No indication recorded.