Cellulite
Conditions
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).
Interventions
DRUGCollagenase Clostridium Histolyticum-Aaes
subjects will be injected with up to 0.84 mg of QWO as 12 subcutaneous injections (0.3-mL injection administered as three 0.1-mL aliquots per injection), dependent on the amount of dimples (0.3 ml per dimple).
DRUGLysteda 650 MG Oral Tablet
Subjects will be given the therapeutic dose of tranexamic acid for menorrhagia, which is 1300 mg PO TID for up to 5 days during menstruation
Sponsors
Luxurgery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post CCH injection degree of bruising with TXA based on the Investigator Assessment of Bruising Severity Scale | 6 months | Scale assessments completed at each follow-up visit. Bruising scale is 0-4, with 0 being no bruise and 4 being the worst bruise possible. A lower number on the bruising scales indicates a better outcome. |
| Post CCH injection degree of bruising with TXA based on Investigator Bruising Improvement Scale (I-BIS). | 6 months | Scale assessments completed at each follow-up visit. Bruising scale is 0-4, with 0 being no bruise and 4 being the worst bruise possible. A lower number on the bruising scales indicates a better outcome. |
Countries
United States
Outcome results
None listed