Clinical trial NCT05419505: Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Edematous Fibrosclerotic Panniculopathy
Cellulite
Keywords: Collagenase Clostridium Histolyticum
collagenase clostridium histolyticum-aaes
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-06-15
Enrollment: 91
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \[CCH-aaes\]).

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.

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 3 to 5 days after initial CCH-aaes injection of left buttock (test) and right buttock (control)
Secondary outcomes:
measure: Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS
timeFrame: Follow-up 1, 2, 3, and 4 after CCH-aaes injection of left buttock (test) and right buttock (control)
measure: Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection
timeFrame: 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
measure: Percentage of Participants With Injection Site Reactions
timeFrame: From Day 1 (after dose) through Day 180
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Endo Clinical Trial Site #6
state: Arizona
city: Beverly Hills
country: United States
facility: Endo Clinical Trial Site #4
state: California
city: Encinitas
country: United States
facility: Endo Clinical Trial Site #9
state: California
city: San Diego
country: United States
facility: Endo Clinical Trial Site #10
state: California
city: Solana Beach
country: United States
facility: Endo Clinical Trial Site #7
state: California
city: Greenwood Village
country: United States
facility: Endo Clinical Trial Site #12
state: Colorado
city: Coral Gables
country: United States
facility: Endo Clinical Trial Site #8
state: Florida
city: Miami
country: United States
facility: Endo Clinical Trial Site #13
state: Florida
city: Chicago
country: United States
facility: Endo Clinical Trial Site #3
state: Illinois
city: Metairie
country: United States
facility: Endo Clinical Trial Site #2
state: Louisiana
city: New York
country: United States
facility: Endo Clinical Trial Site #11
state: New York
city: Nashville
country: United States
facility: Endo Clinical Trial Site #1
state: Tennessee
city: Pflugerville
country: United States
facility: Endo Clinical Trial Site #5
state: Texas
Study officials:
affiliation: Endo Pharmaceuticals
name: David Hernandez
role: STUDY_DIRECTOR
References: