Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks (APHRODITE)

Endo Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Cellulite; Edematous Fibrosclerotic Panniculopathy

Treatments: Drug: CCH-aaes; Drug: Antifibrinolytic Agent

Study type: Interventional

Funder types: Industry

Identifiers

NCT05419505

EN3835-226

Details and patient eligibility

About

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]).

Full 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.

Enrollment: 91 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 7 patient groups

Cohort 1: CCH-aaes Dose Evaluation

Experimental group

Description:

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:

Drug: CCH-aaes

Cohort 2: CCH-aaes Concentration Evaluation

Experimental group

Description:

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.

Treatment:

Drug: CCH-aaes

Cohort 3: CCH-aaes Injection Depth Evaluation

Experimental group

Description:

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.

Treatment:

Drug: CCH-aaes

Cohort 4: CCH-aaes Injection Method Evaluation

Experimental group

Description:

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.

Treatment:

Drug: CCH-aaes

Cohort 5: CCH-aaes and Diluent Additive Evaluation

Experimental group

Description:

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.

Treatment:

Drug: CCH-aaes

Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation

Experimental group

Description:

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.

Treatment:

Drug: CCH-aaes

Cohort 7: CCH-aaes and Antifibrinolytic Agent

Experimental group

Description:

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.

Treatment:

Drug: Antifibrinolytic Agent

Drug: CCH-aaes