CellulitePhase 4NCT05309525
Effect of Oral TXA on Buttock Bruising Post CCH Injections in Adult Females
A Phase 4 study testing Collagenase Clostridium Histolyticum-Aaes and Lysteda 650 MG Oral Tablet in people with Cellulite, run by Luxurgery at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cellulite
- What is being tested?
- Collagenase Clostridium Histolyticum-Aaes and Lysteda 650 MG Oral Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2022to 1 Oct 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Cellulite
- Being tested
- Collagenase Clostridium Histolyticum-Aaes, Lysteda 650 MG Oral Tablet
- Medical subject headings
- Cellulite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagenase Clostridium Histolyticum-AaesDrug
Also called QWO
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).
Lysteda 650 MG Oral TabletDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Active comparator | 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. Receives: Drug: Collagenase Clostridium Histolyticum-Aaes; Drug: Lysteda 650 MG Oral Tablet |
| Cohort B | Active comparator | 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. Receives: Drug: Collagenase Clostridium Histolyticum-Aaes; Drug: Lysteda 650 MG Oral Tablet |
| Cohort C | Active comparator | 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. Receives: Drug: Collagenase Clostridium Histolyticum-Aaes; Drug: Lysteda 650 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start22 Apr 2022
- Primary completion1 Sep 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CelluliteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luxurgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Sachin Shridharani, Luxurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309525
- Sponsor's protocol ID
- LUX-EN-001
- Status last verified
- Mar 2023
- First submitted
- 24 Mar 2022
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral TXA on Buttock Bruising Post CCH Injections in Adult Females
- ClinicalTrials.gov ID
- NCT05309525
- Acronym / sponsor ID
- LUX-EN-001
- Conditions
- Cellulite
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- LuxurgeryIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Active comparator | Drug: Collagenase Clostridium Histolyticum-Aaes, Drug: Lysteda 650 MG Oral TabletPer 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. |
| Cohort B | Active comparator | Drug: Collagenase Clostridium Histolyticum-Aaes, Drug: Lysteda 650 MG Oral TabletPer 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. |
| Cohort C | Active comparator | Drug: Collagenase Clostridium Histolyticum-Aaes, Drug: Lysteda 650 MG Oral TabletPer 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collagenase Clostridium Histolyticum-AaesAlso: QWOsubjects 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). | Drug | Cohort A, Cohort B, Cohort C |
| Lysteda 650 MG Oral TabletSubjects will be given the therapeutic dose of tranexamic acid for menorrhagia, which is 1300 mg PO TID for up to 5 days during menstruation | Drug | Cohort A, Cohort B, Cohort C |
Primary outcome
Post CCH injection degree of bruising with TXA based on the Investigator Assessment of Bruising Severity Scale
Time frame: 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).
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Collagenase Clostridium Histolyticum-Aaes and Lysteda 650 MG Oral Tablet in people with Cellulite, run by Luxurgery at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post CCH injection degree of bruising with TXA based on the Investigator Assessment of Bruising Severity Scale (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.