Clinical trial NCT05309525: Effect of Oral TXA on Buttock Bruising Post CCH Injections in Adult Females
Official title: Effect of Oral TXA on Buttock Bruising Post CCH Injections in Adult Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cellulite
Lead sponsor: Luxurgery
Sponsor class: INDUSTRY
First posted: 2022-04-04
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).


Eligibility criteria: Inclusion .

* Female \> 18 and \< 55 years of age.
* At the screening visit, have buttocks with moderate to severe cellulite based on the CR-PCSS.
* Be willing and able to comply with all protocol required visits and assessments.
* Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of the study.
* Is willing to refrain from exercise for 24 hours following each treatment.
* Be adequately informed and understand the nature and risks of the study.

Exclusion.

* Has a history of hypersensitivity or allergy to collagenase of any other excipient of CCH.
* At the screening visit, has none, almost none, or mild cellulite.
* At the screening visit, per the investigator, has cellulite that would require less than 6 injections per buttock, or more than 12 injections per buttock.
* Is pregnant and/or is breast-feeding or plans to become pregnant and/or to breast-feed during the course of the study, or 28 days after the last treatment.
* Is currently undergoing hormone replacement therapy or has undergone hormone replacement therapy in the past 6 months.
* Has a coagulation disorder which requires anticoagulant or antiplatelet medication during the study, or has taken anticoagulant or antiplatelet medication within 14 days before injections.
* Is currently taking oral contraceptive pills.
* Is currently a smoker, or has smoked within the last year prior to screening.
* Has a history of scarring due to keloids or abnormal wound healing.
* Has received previous treatment with CCH for cellulite, or any other cellulite treatment.
* Subject has any history of anemia or taking iron pills.

Primary outcomes:
measure: Post CCH injection degree of bruising with TXA based on the Investigator Assessment of Bruising Severity Scale
timeFrame: 6 months
measure: Post CCH injection degree of bruising with TXA based on Investigator Bruising Improvement Scale (I-BIS).
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Luxurgery
state: New York
Study officials:
References: