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Enzyme

CCH-aaes for Cellulite (APHRODITE Trial)

Phase 2
Waitlist Available
Research Sponsored by Endo Pharmaceuticals
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 3 to 5 days after initial cch-aaes injection on day 1 (cohorts 1 to 7) and day 22 (cohort 7 only)
Awards & highlights

APHRODITE Trial Summary

This trial will test different ways of injecting a drug called QWO, to see how it affects bruising.

Eligible Conditions
  • Cellulite

APHRODITE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 to 5 days after initial cch-aaes injection on day 1 (cohorts 1 to 7) and day 22 (cohort 7 only)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 to 5 days after initial cch-aaes injection on day 1 (cohorts 1 to 7) and day 22 (cohort 7 only) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with at Least 1-Level Lower Score for the Left Buttock (Investigational) Versus the Right Buttock (Control), as Assessed by the Investigator Assessment of Bruising Severity Scale (IABSS) After Initial CCH-aaes Injection
Secondary outcome measures
Number of Participants with Injection Site Reactions in the Left Buttock (Investigational) Versus the Right Buttock (Control)
Number of Participants with Treatment-emergent Adverse Events
Number of Participants with at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection
+1 more

Side effects data

From 2021 Phase 4 trial • 48 Patients • NCT04677712
100%
Injection site bruising
63%
Injection site pain
25%
Injection site discolouration
13%
Contusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 5: CCH-aaes + INhance Post-Injection Serum With TriHex Technology®
Cohort 2: CCH-aaes + Compression Garment
Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend)
Cohort 1: CCH-aaes
Cohort 3:CCH-aaes + Instant Cold Packs
Cohort 6: CCH-aaes + PDL

APHRODITE Trial Design

7Treatment groups
Experimental Treatment
Group I: Cohort 7: CCH-aaes and Antifibrinolytic AgentExperimental Treatment2 Interventions
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.
Group II: Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule EvaluationExperimental Treatment1 Intervention
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.
Group III: Cohort 5: CCH-aaes and Diluent Additive EvaluationExperimental Treatment1 Intervention
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.
Group IV: Cohort 4: CCH-aaes Injection Method EvaluationExperimental Treatment1 Intervention
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.
Group V: Cohort 3: CCH-aaes Injection Depth EvaluationExperimental Treatment1 Intervention
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.
Group VI: Cohort 2: CCH-aaes Concentration EvaluationExperimental Treatment1 Intervention
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.
Group VII: Cohort 1: CCH-aaes Dose EvaluationExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Antifibrinolytic Agent
2022
Completed Phase 2
~100
Collagenase clostridium histolyticum
FDA approved

Find a Location

Who is running the clinical trial?

Endo PharmaceuticalsLead Sponsor
133 Previous Clinical Trials
34,905 Total Patients Enrolled
17 Trials studying Cellulite
2,664 Patients Enrolled for Cellulite
David HernandezStudy DirectorEndo Pharmaceuticals
2 Previous Clinical Trials
188 Total Patients Enrolled
2 Trials studying Cellulite
188 Patients Enrolled for Cellulite

Frequently Asked Questions

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

Are we looking for more participants in this clinical trial?

"The clinical trial is currently ongoing, as seen on clinicaltrials.gov. This specific study was first posted on June 15th, 2022 and updated August 18th, 2022."

Answered by AI

How many research facilities in North America are conducting this investigation?

"Enrolling patients can be found at 13 different locations, including but not limited to Endo Clinical Trial Site #2 in Metairie, Endo Clinical Trial Site #11 in New york, and Endo Clinical Trial Site #1 in Nashville."

Answered by AI

Which type of patient does this clinical trial seek to enroll?

"This scientific study is testing a new intervention for cellulite in patients aged 18-60. They will be enrolling 180 individuals in total."

Answered by AI

How many individuals are currently enrolled in this trial?

"This study requires 180 individuals that match the pre-determined inclusion criteria. These potential participants can be recruited from multiple locations, such as Endo Clinical Trial Site #2 in Metairie, Louisiana and Endo Clinical Trial Site #11 in New york, New York."

Answered by AI

Are people of retirement age eligible for this research project?

"Eligibility requirements for this clinical trial include being between the ages of 18-60."

Answered by AI

How does the safety profile of CCH-aaes compare to other treatments?

"CCH-aaes falls into the category of a Phase 2 trial, so it has received a score of 2. This means that while there is some evidence supporting its safety, there are no studies proving its efficacy."

Answered by AI

Who else is applying?

What state do they live in?
California
Florida
New York
Other
How old are they?
18 - 65
What site did they apply to?
Endo Clinical Trial Site #4
Endo Clinical Trial Site #8
Endo Clinical Trial Site #11
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0

Why did patients apply to this trial?

I have horrible cellulite. I've tried a few other options to get rid of cellulite.
PatientReceived 2+ prior treatments
I've always struggled with cellulite and interested in finding a solution.
PatientReceived no prior treatments
I’ve had cellulite since elementary school. Didn’t even weight 110 pounds when I graduated high school and had tons of cellulite. It depresses me looking for some way I can get rid of it I can afford. It’s mostly on the back of my thighs like a lot of my knee. Even at my fittest it’s still really bad.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How responsive is this trial?

Most responsive sites:
  1. Endo Clinical Trial Site #11: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks
2022. "Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05419505.
~32 spots leftby Apr 2025
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