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

• Status: Not yet recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: Female

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]).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Endo Pharmaceuticals

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 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.