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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
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

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]).

Condition or disease Intervention/treatment Phase
Edematous Fibrosclerotic Panniculopathy Cellulite Drug: CCH-aaes Drug: Antifibrinolytic Agent Phase 2

Detailed Description:
The study will comprise a Screening Period (28 days), Treatment Period (90 days), and Follow-up Period (90 days). Participants will receive CCH-aaes in different doses, concentrations, diluent additives, depths of injection, and methods of injection in a split buttock arrangement, with the right buttock serving as the control, and the left buttock (investigational side) receiving a study intervention.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bruises

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:
  • Collagenase clostridium histolyticum-aaes
  • QWO®

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:
  • Collagenase clostridium histolyticum-aaes
  • QWO®

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:
  • Collagenase clostridium histolyticum-aaes
  • QWO®

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:
  • Collagenase clostridium histolyticum-aaes
  • QWO®

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:
  • Collagenase clostridium histolyticum-aaes
  • QWO®

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:
  • Collagenase clostridium histolyticum-aaes
  • QWO®

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:
  • Collagenase clostridium histolyticum-aaes
  • QWO®

Drug: Antifibrinolytic Agent
Self-administered by participants enrolled in Cohort 7.




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Number of Participants with Treatment-emergent Adverse Events [ Time Frame: Up to Day 180 ]
  4. Number of Participants with Injection Site Reactions in the Left Buttock (Investigational) Versus the Right Buttock (Control) [ Time Frame: Up to Day 180 ]


Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:

    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.

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
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Study Director: David Hernandez Endo Pharmaceuticals
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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)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Endo Pharmaceuticals:
Collagenase Clostridium Histolyticum
collagenase clostridium histolyticum-aaes
Additional relevant MeSH terms:
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Cellulite
Skin Manifestations
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants