Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks (APHRODITE)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05419505 |
Recruitment Status :
Active, not recruiting
First Posted : June 15, 2022
Last Update Posted : January 19, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Edematous Fibrosclerotic Panniculopathy Cellulite | Drug: CCH-aaes Drug: Antifibrinolytic Agent | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 91 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | APHRODITE-1: A Phase 2, Open Label, Self-Controlled Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks in Adult Females |
Actual Study Start Date : | June 15, 2022 |
Actual Primary Completion Date : | January 3, 2023 |
Estimated Study Completion Date : | May 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: 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.
|
Drug: CCH-aaes
Administered by subcutaneous injection.
Other Names:
|
Experimental: 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.
|
Drug: CCH-aaes
Administered by subcutaneous injection.
Other Names:
|
Experimental: 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.
|
Drug: CCH-aaes
Administered by subcutaneous injection.
Other Names:
|
Experimental: 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.
|
Drug: CCH-aaes
Administered by subcutaneous injection.
Other Names:
|
Experimental: 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.
|
Drug: CCH-aaes
Administered by subcutaneous injection.
Other Names:
|
Experimental: 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.
|
Drug: CCH-aaes
Administered by subcutaneous injection.
Other Names:
|
Experimental: 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.
|
Drug: CCH-aaes
Administered by subcutaneous injection.
Other Names:
Drug: Antifibrinolytic Agent Self-administered by participants enrolled in Cohort 7. |
- 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 [ Time Frame: 3 to 5 days after initial CCH-aaes injection on Day 1 (Cohorts 1 to 7) and Day 22 (Cohort 7 only) ]
- Number of Participants with at Least 1-Level Lower Score for the Left Buttock (Investigational) Versus the Right Buttock (Control), as Assessed by the IABSS After CCH-aaes Injection [ Time Frame: Up to Day 64 ]
- Number of Participants with at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection [ Time Frame: From Day 22 through Day 180 ]
- Number of Participants with Treatment-emergent Adverse Events [ Time Frame: Up to Day 180 ]
- Number of Participants with Injection Site Reactions in the Left Buttock (Investigational) Versus the Right Buttock (Control) [ Time Frame: Up to Day 180 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Have a body mass index of 18 to <32 kilograms (kg)/meter (m)^2 and intends to maintain stable body weight during the study.
- 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.
Key Exclusion Criteria:
- Has systemic conditions (coagulation disorders, skin pigmentation disorders, malignancy, keloidal scarring, abnormal wound healing) that restricts study participation.
- 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.
In addition to the applicable aforementioned exclusion criteria, participants enrolling in Cohort 7 will be excluded from study participation if the participant:
-
Has any of the following medical conditions:
- history of venous or arterial thromboembolism or current thromboembolic disease.
- history of or current renal impairment.
- 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:
- concurrently taking combination hormonal contraceptives.
- concurrently undergoing hormone replacement therapy.
- is a current smoker of nicotine or cannabinoids.
- Participants in Cohort 7 should avoid smoking (including vaping, nicotine, or marijuana cigarettes) during the study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05419505
United States, Arizona | |
Endo Clinical Trial Site #6 | |
Scottsdale, Arizona, United States, 85255 | |
United States, California | |
Endo Clinical Trial Site #4 | |
Beverly Hills, California, United States, 90210 | |
Endo Clinical Trial Site #9 | |
Encinitas, California, United States, 92024 | |
Endo Clinical Trial Site #10 | |
San Diego, California, United States, 92121 | |
Endo Clinical Trial Site #7 | |
Solana Beach, California, United States, 92075 | |
United States, Colorado | |
Endo Clinical Trial Site #12 | |
Greenwood Village, Colorado, United States, 80111 | |
United States, Florida | |
Endo Clinical Trial Site #8 | |
Coral Gables, Florida, United States, 33146 | |
Endo Clinical Trial Site #13 | |
Miami, Florida, United States, 33137 | |
United States, Illinois | |
Endo Clinical Trial Site #3 | |
Chicago, Illinois, United States, 60611 | |
United States, Louisiana | |
Endo Clinical Trial Site #2 | |
Metairie, Louisiana, United States, 700006 | |
United States, New York | |
Endo Clinical Trial Site #11 | |
New York, New York, United States, 10021 | |
United States, Tennessee | |
Endo Clinical Trial Site #1 | |
Nashville, Tennessee, United States, 37215 | |
United States, Texas | |
Endo Clinical Trial Site #5 | |
Pflugerville, Texas, United States, 78660 |
Study Director: | David Hernandez | Endo Pharmaceuticals |
Responsible Party: | Endo Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT05419505 |
Other Study ID Numbers: |
EN3835-226 |
First Posted: | June 15, 2022 Key Record Dates |
Last Update Posted: | January 19, 2023 |
Last Verified: | January 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Collagenase Clostridium Histolyticum collagenase clostridium histolyticum-aaes |
Cellulite Skin Manifestations Antifibrinolytic Agents Fibrin Modulating Agents |
Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |