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

Cellulite Clinical Trial

— APHRODITE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05419505
• Other study ID #: EN3835-226
• Status: Completed
• Phase: Phase 2
• Start date: June 15, 2022
• Est. completion date: June 21, 2023

Study information

• Verified date: July 2023
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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]).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: June 21, 2023
• Est. primary completion date: January 3, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cellulite
• Edematous Fibrosclerotic Panniculopathy

Intervention

Drug:
• CCH-aaes
Administered by subcutaneous injection.
• Antifibrinolytic Agent
Self-administered by participants enrolled in Cohort 7.

Locations

Country	Name	City	State
United States	Endo Clinical Trial Site #4	Beverly Hills	California
United States	Endo Clinical Trial Site #3	Chicago	Illinois
United States	Endo Clinical Trial Site #8	Coral Gables	Florida
United States	Endo Clinical Trial Site #9	Encinitas	California
United States	Endo Clinical Trial Site #12	Greenwood Village	Colorado
United States	Endo Clinical Trial Site #2	Metairie	Louisiana
United States	Endo Clinical Trial Site #13	Miami	Florida
United States	Endo Clinical Trial Site #1	Nashville	Tennessee
United States	Endo Clinical Trial Site #11	New York	New York
United States	Endo Clinical Trial Site #5	Pflugerville	Texas
United States	Endo Clinical Trial Site #10	San Diego	California
United States	Endo Clinical Trial Site #6	Scottsdale	Arizona
United States	Endo Clinical Trial Site #7	Solana Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		3 to 5 days after initial CCH-aaes injection on Day 1 (Cohorts 1 to 7) and Day 22 (Cohort 7 only)
Secondary	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		Up to Day 64
Secondary	Number of Participants with at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection		From Day 22 through Day 180
Secondary	Number of Participants with Treatment-emergent Adverse Events		Up to Day 180
Secondary	Number of Participants with Injection Site Reactions in the Left Buttock (Investigational) Versus the Right Buttock (Control)		Up to Day 180