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

Primary Purpose

Cellulite

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Collagenase Clostridium Histolyticum-Aaes
Lysteda 650 MG Oral Tablet
Sponsored by
Luxurgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cellulite

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Luxurgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Cohort A

Cohort B

Cohort C

Arm Description

Per treatment area, 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). A treatment area is defined as a left or right buttock, so patients may receive up to 1.84 mg, or 24 injections total (2 areas per treatment visit). The minimum dosage of QWO will be 0.92 mg, or 6 injections per treatment area (2 areas per treatment visit. Cohort A subjects will be given 1300 mg tranexamic acid PO TID prior to the day of the first CCH injections, the day of the first CCH injections, and the 3 days following the first CCH injections.

Per treatment area, 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). A treatment area is defined as a left or right buttock, so patients may receive up to 1.84 mg, or 24 injections total (2 areas per treatment visit). The minimum dosage of QWO will be 0.92 mg, or 6 injections per treatment area (2 areas per treatment visit. Cohort B subjects will be given 1300 mg tranexamic acid PO TID prior to the day of the first and second CCH injections, the day of the first and second CCH injection, and the 3 days following the first and second CCH injections.

Per treatment area, 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). A treatment area is defined as a left or right buttock, so patients may receive up to 1.84 mg, or 24 injections total (2 areas per treatment visit). The minimum dosage of QWO will be 0.92 mg, or 6 injections per treatment area (2 areas per treatment visit. Cohort C subjects will be given 1300 mg tranexamic acid PO TID prior to the day of the first, second, and third CCH injections, the day of the first, second, and third CCH injection, and the 3 days following the first, second, and third CCH injections.

Outcomes

Primary Outcome Measures

Post CCH injection degree of bruising with TXA based on the Investigator Assessment of Bruising Severity Scale
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).
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.

Secondary Outcome Measures

Full Information

First Posted
March 24, 2022
Last Updated
March 7, 2023
Sponsor
Luxurgery
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1. Study Identification

Unique Protocol Identification Number
NCT05309525
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 22, 2022 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Luxurgery

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cellulite

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort A
Arm Type
Active Comparator
Arm Description
Per treatment area, 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). A treatment area is defined as a left or right buttock, so patients may receive up to 1.84 mg, or 24 injections total (2 areas per treatment visit). The minimum dosage of QWO will be 0.92 mg, or 6 injections per treatment area (2 areas per treatment visit. Cohort A subjects will be given 1300 mg tranexamic acid PO TID prior to the day of the first CCH injections, the day of the first CCH injections, and the 3 days following the first CCH injections.
Arm Title
Cohort B
Arm Type
Active Comparator
Arm Description
Per treatment area, 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). A treatment area is defined as a left or right buttock, so patients may receive up to 1.84 mg, or 24 injections total (2 areas per treatment visit). The minimum dosage of QWO will be 0.92 mg, or 6 injections per treatment area (2 areas per treatment visit. Cohort B subjects will be given 1300 mg tranexamic acid PO TID prior to the day of the first and second CCH injections, the day of the first and second CCH injection, and the 3 days following the first and second CCH injections.
Arm Title
Cohort C
Arm Type
Active Comparator
Arm Description
Per treatment area, 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). A treatment area is defined as a left or right buttock, so patients may receive up to 1.84 mg, or 24 injections total (2 areas per treatment visit). The minimum dosage of QWO will be 0.92 mg, or 6 injections per treatment area (2 areas per treatment visit. Cohort C subjects will be given 1300 mg tranexamic acid PO TID prior to the day of the first, second, and third CCH injections, the day of the first, second, and third CCH injection, and the 3 days following the first, second, and third CCH injections.
Intervention Type
Drug
Intervention Name(s)
Collagenase Clostridium Histolyticum-Aaes
Other Intervention Name(s)
QWO
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Lysteda 650 MG Oral Tablet
Intervention Description
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
Primary Outcome Measure Information:
Title
Post CCH injection degree of bruising with TXA based on the Investigator Assessment of Bruising Severity Scale
Description
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.
Time Frame
6 months
Title
Post CCH injection degree of bruising with TXA based on Investigator Bruising Improvement Scale (I-BIS).
Description
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.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Luxurgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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

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