Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks
NCT ID: NCT05419505
Last Updated: 2025-03-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
91 participants
INTERVENTIONAL
2022-06-15
2023-06-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety Study of Protein C Concentrate in Subjects With Severe Congenital Protein C Deficiency
NCT00157118
A Study to Evaluate the Effects of Pharmacological Chaperones in Cells From Patients With Pompe Disease
NCT00515398
A Study of CSTI-500 in Patients With Prader-Willi Syndrome
NCT07348601
A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZYIL1 in Subjects With Cryopyrin Associated Periodic Syndromes (CAPS)
NCT05186051
Pharmacokinetics and Safety Study of Single and Multiple Oral Doses Prodarsan™ in Patients With Cockayne Syndrome
NCT01142154
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1: CCH-aaes Dose Evaluation
Participants will be administered CCH-aaes at different doses. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.
CCH-aaes
Administered by subcutaneous injection.
Cohort 2: CCH-aaes Concentration Evaluation
Participants will be administered CCH-aaes at different concentrations. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.
CCH-aaes
Administered by subcutaneous injection.
Cohort 3: CCH-aaes Injection Depth Evaluation
Participants will be administered CCH-aaes using different injection depths. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.
CCH-aaes
Administered by subcutaneous injection.
Cohort 4: CCH-aaes Injection Method Evaluation
Participants will be administered CCH-aaes using different injection methods. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.
CCH-aaes
Administered by subcutaneous injection.
Cohort 5: CCH-aaes and Diluent Additive Evaluation
Participants will be administered CCH-aaes and diluent additive. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.
CCH-aaes
Administered by subcutaneous injection.
Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation
Participants will be administered CCH-aaes using a different treatment schedule and different doses and concentrations. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.
CCH-aaes
Administered by subcutaneous injection.
Cohort 7: CCH-aaes and Antifibrinolytic Agent
Participants will be administered CCH-aaes and an antifibrinolytic agent. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.
CCH-aaes
Administered by subcutaneous injection.
Antifibrinolytic Agent
Self-administered by participants enrolled in Cohort 7.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CCH-aaes
Administered by subcutaneous injection.
Antifibrinolytic Agent
Self-administered by participants enrolled in Cohort 7.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Have both buttocks with moderate or severe cellulite as reported by the investigator using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS).
* Have a Hexsel Cellulite Severity Scale (CSS) Total Score of ≤12.
* Has a Fitzpatrick Skin Type of I-IV
* Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of participation in the study.
* Be willing and able to comply with the requirements of the study.
Exclusion Criteria
* Is pregnant and/or is breast-feeding or plans to become pregnant and/or to breast-feed during the course of the study.
* Has any local (in the areas to be treated) conditions (thrombosis, post-thrombosis syndrome, vascular disorder, inflammation, active infection, active cutaneous alteration, tattoo or mole) that restricts study participation.
* Requires antiplatelet medication, anticoagulants, or non-steroidal anti-inflammatory drugs during the study.
* Any medications, supplements, or foods that have, or have been reported to have anticoagulant effects within 14 days of treatment.
* Has received treatment with investigational treatment within 30 days before treatment.
* Has used or intends to use any of the local applications, therapies, injections, or procedures for the treatment of cellulite on either buttock that would restrict study participation.
* Intends to initiate an intensive sport or exercise program or intensive weight reduction program during the study.
* Intends to engage in strenuous activity within 48 hours of study intervention administration.
* Has recently tanned or intends to tan (outdoors or indoors) during the study.
* Has a history of hypersensitivity or allergy to collagenase or any other excipient of CCH.
* Has any condition(s) that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.
* Has participated in a previous investigational study of CCH or received any collagenase treatments at any time prior to treatment in this study for the treatment of cellulite of the buttocks.
* Has any of the following medical conditions:
1. history of venous or arterial thromboembolism or current thromboembolic disease.
2. history of or current renal impairment.
3. serum creatinine concentration \> 1.4 milligram/deciliter at Screening.
* Requires the following concomitant medications during the study and cannot discontinue these medications within the time specified before CCH-aaes treatment:
1. concurrently taking combination hormonal contraceptives.
2. concurrently undergoing hormone replacement therapy.
3. is a current smoker of nicotine or cannabinoids.
* Participants in Cohort 7 should avoid smoking (including vaping, nicotine, or marijuana cigarettes) during the study.
18 Years
60 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Endo Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David Hernandez
Role: STUDY_DIRECTOR
Endo Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Endo Clinical Trial Site #6
Scottsdale, Arizona, United States
Endo Clinical Trial Site #4
Beverly Hills, California, United States
Endo Clinical Trial Site #9
Encinitas, California, United States
Endo Clinical Trial Site #10
San Diego, California, United States
Endo Clinical Trial Site #7
Solana Beach, California, United States
Endo Clinical Trial Site #12
Greenwood Village, Colorado, United States
Endo Clinical Trial Site #8
Coral Gables, Florida, United States
Endo Clinical Trial Site #13
Miami, Florida, United States
Endo Clinical Trial Site #3
Chicago, Illinois, United States
Endo Clinical Trial Site #2
Metairie, Louisiana, United States
Endo Clinical Trial Site #11
New York, New York, United States
Endo Clinical Trial Site #1
Nashville, Tennessee, United States
Endo Clinical Trial Site #5
Pflugerville, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EN3835-226
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.