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Cohort A for Cellulite

Phase 4
Waitlist Available
Research Sponsored by Luxurgery
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial is testing whether the drug Lysteda reduces bruising after injections to the buttocks for female subjects with moderate to severe cellulite. The subjects will be given the drug at different times during the study to see if it has an effect on bruising. There will be a total of 11 visits over the course of 65 days.

Eligible Conditions
  • Cellulite

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Post CCH injection degree of bruising with TXA based on Investigator Bruising Improvement Scale (I-BIS).
Post CCH injection degree of bruising with TXA based on the Investigator Assessment of Bruising Severity Scale

Trial Design

3Treatment groups
Active Control
Group I: Cohort AActive Control2 Interventions
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.
Group II: Cohort CActive Control2 Interventions
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.
Group III: Cohort BActive Control2 Interventions
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.

Find a Location

Who is running the clinical trial?

LuxurgeryLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
New York
Other
Connecticut
North Carolina
How old are they?
18 - 65
What site did they apply to?
Luxurgery
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Luxurgery: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Effect of Oral TXA on Buttock Bruising Post CCH Injections in Adult Females
Sachin Shridharani 2022. "Effect of Oral TXA on Buttock Bruising Post CCH Injections in Adult Females". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05309525.
~6 spots leftby Apr 2025
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