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

NCT05309525 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2023-03-08

No results posted yet for this study

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).

Conditions

  • Cellulite

Interventions

DRUG

Collagenase 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).

DRUG

Lysteda 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 & Collaborators

  • Luxurgery

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-22
Primary Completion
2022-09-01
Completion
2022-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05309525 on ClinicalTrials.gov