Status:
COMPLETED
Effect of Oral TXA on Buttock Bruising Post CCH Injections in Adult Females
Lead Sponsor:
Luxurgery
Conditions:
Cellulite
Eligibility:
FEMALE
18-55 years
Phase:
PHASE4
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 sever...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT05309525
Start Date
April 22 2022
End Date
October 1 2022
Last Update
March 8 2023
Active Locations (1)
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1
Luxurgery
New York, New York, United States, 10021