Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks
APHRODITE
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
1 other identifier
interventional
91
1 country
13
Brief Summary
The study will evaluate the effect of different doses, strengths (concentrations), diluent additives, depths of injection, and methods of injection on the severity of bruising potentially induced by QWO (collagenase clostridium histolyticum-aaes \[CCH-aaes\]).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2022
Shorter than P25 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2022
CompletedFirst Posted
Study publicly available on registry
June 15, 2022
CompletedStudy Start
First participant enrolled
June 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 3, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 21, 2023
CompletedResults Posted
Study results publicly available
March 7, 2025
CompletedMarch 7, 2025
March 1, 2025
7 months
June 9, 2022
January 2, 2024
March 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With at Least 1-Level Lower Score 3 to 5 Days After Initial CCH-aaes Injection, as Assessed by the Investigator Assessment of Bruising Severity Scale (IABSS) After Initial CCH-aaes Injection
The investigator assessed the severity of bruising using the IABSS, The IABSS is a 5-point scale ranging from 0-4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcomes. The investigator compared the bruising of the left (test) buttock to the right (control) buttock. Responders were participants whose left buttock/test side demonstrated at least a 1-level lower IABSS score versus the right buttock/control side. Percentages are based on the number of participants with an assessment at specified timepoint.
3 to 5 days after initial CCH-aaes injection of left buttock (test) and right buttock (control)
Secondary Outcomes (3)
Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS
Follow-up 1, 2, 3, and 4 after CCH-aaes injection of left buttock (test) and right buttock (control)
Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection
Day 22 and Day 43 for Cohorts 1 to 5, Day 43 for Cohort 6, Day 22, Day 43, and Day 64 for Cohort 7, and Day 90, Day 135, and Day 180 for all cohorts
Percentage of Participants With Injection Site Reactions
From Day 1 (after dose) through Day 180
Study Arms (7)
Cohort 1: CCH-aaes Dose Evaluation
EXPERIMENTALParticipants 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.
Cohort 2: CCH-aaes Concentration Evaluation
EXPERIMENTALParticipants 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.
Cohort 3: CCH-aaes Injection Depth Evaluation
EXPERIMENTALParticipants 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.
Cohort 4: CCH-aaes Injection Method Evaluation
EXPERIMENTALParticipants 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.
Cohort 5: CCH-aaes and Diluent Additive Evaluation
EXPERIMENTALParticipants 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.
Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation
EXPERIMENTALParticipants 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.
Cohort 7: CCH-aaes and Antifibrinolytic Agent
EXPERIMENTALParticipants 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.
Interventions
Administered by subcutaneous injection.
Self-administered by participants enrolled in Cohort 7.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Has any of the following medical conditions:
- history of venous or arterial thromboembolism or current thromboembolic disease.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Endo Clinical Trial Site #6
Scottsdale, Arizona, 85255, United States
Endo Clinical Trial Site #4
Beverly Hills, California, 90210, United States
Endo Clinical Trial Site #9
Encinitas, California, 92024, United States
Endo Clinical Trial Site #10
San Diego, California, 92121, United States
Endo Clinical Trial Site #7
Solana Beach, California, 92075, United States
Endo Clinical Trial Site #12
Greenwood Village, Colorado, 80111, United States
Endo Clinical Trial Site #8
Coral Gables, Florida, 33146, United States
Endo Clinical Trial Site #13
Miami, Florida, 33137, United States
Endo Clinical Trial Site #3
Chicago, Illinois, 60611, United States
Endo Clinical Trial Site #2
Metairie, Louisiana, 700006, United States
Endo Clinical Trial Site #11
New York, New York, 10021, United States
Endo Clinical Trial Site #1
Nashville, Tennessee, 37215, United States
Endo Clinical Trial Site #5
Pflugerville, Texas, 78660, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was halted before the predetermined sample size was enrolled, therefore, was not adequately powered to draw conclusions or to make comparisons between cohorts.
Results Point of Contact
- Title
- Clinical Operations
- Organization
- Endo Pharmaceuticals
Study Officials
- STUDY DIRECTOR
David Hernandez
Endo Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2022
First Posted
June 15, 2022
Study Start
June 15, 2022
Primary Completion
January 3, 2023
Study Completion
June 21, 2023
Last Updated
March 7, 2025
Results First Posted
March 7, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP