Effects of Mitigation Treatments on Bruising of CCH-aaes Treatment of Buttock Cellulite

• Status: Completed
• Trial end date: 2021-09-02
• Target enrollment: 0
• Participant gender: Female

Summary

QWO™ (CCH-aaes) is indicated for the treatment of moderate to severe cellulite in the buttocks of adult women. QWO™ (CCH-aaes)-related post-injection bruising was the most common adverse reaction; generally, resolving within 21 days. Since bruising may be bothersome to patients, this study will investigate treatments that may mitigate bruising after QWO™ (CCH-aaes) treatment of cellulite in the buttocks.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Endo Pharmaceuticals
• Collaborators: Brian Biesman, MD, PLLC; DeNova Research; Investigate MD, LLC; Laser & Skin Surgery Medical Group, Inc.; Mathew Avram, MD; Plastic Surgical Associates of Fort Collins, P.C.; The Wall Center for Plastic Surgery; UCSD Dermatology

Criteria

Inclusion Criteria:

1. Have both buttocks with:

1. a CR-PCSS score of 3 (moderate) as reported by the Investigator, and

2. a Hexsel CSS Subsection D "Grade of laxity, flaccidity, or sagging skin" score of 0 (absence of laxity, flaccidity, or sagging skin) or 1 (slightly draped appearance).

2. Have a body mass index between ≥18 and ≤30 kg/m^2.

3. Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of the study (from Screening Visit through the Day 71/Early Termination Visit).

4. Be judged to be in good health.

5. Be willing and able to cooperate with the requirements of the study.

Exclusion Criteria:

1. Has Coagulation disorder, which requires anticoagulant or antiplatelet medication during the study (except for < 150 mg aspirin daily), or has taken anticoagulant or antiplatelet medication(s) within 14 days before injection of study treatment (except for < 150 mg aspirin daily).

2. Has local conditions in the areas to be treated (Thrombosis, Vascular disorder, Active infection/inflammation, Active cutaneous alteration, Tattoo/mole) that restricts study participation.

3. Has skin laxity or linear undulations on buttocks that can be effaced by lifting skin.

4. Requires the following concomitant medications during the study and cannot discontinue these medications within the time specified before QWO (CCH-aaes) treatment.

1. Antiplatelet medication (clopidogrel [Plavix®] including aspirin at any dose within 14 days of treatment.

2. Anticoagulants, such as warfarin (Coumadin®); heparin analogues within 14 days of treatment.

3. Non-steroidal anti-inflammatory drugs (NSAIDS), such as ibuprofen (Motrin®, Advil®) and naproxen (Aleve®) 7 days before the study.

4. Any medications or food that have, or have been reported to have anticoagulant effects within 14 days of treatment.

5. Antibiotics, such as penicillin and cephalosporin within 48 hours of treatment.

5. Has used or intends to use any of the local applications/therapies/injections/procedures that restricts study participation.

6. Is pregnant and/or is presently nursing or providing breast milk or plans to become pregnant during the study.

7. Intends to initiate an intensive sport or exercise program during the study.

8. Tanning or use of tanning agents.

9. Intends to engage in strenuous activity within 48 hours after the first injection of QWO (CCH-aaes).

10. Has received an investigational drug or treatment within 30 days prior to injection of QWO (CCH-aaes).

11. Has a history of hypersensitivity or allergy to collagenase or any other excipient of QWO (CCH-aaes).

12. Has a known systemic allergy or local sensitivity to any of the mitigation treatments or including excipients (ie, arnica patches, INhance Post-injection Serum).

13. Has received any collagenase treatments at any time prior to treatment in this study and/or has received EN3835 or QWO (CCH-aaes) in a previous investigational study for cellulite.

14. For subjects allocated to PDL treatment Subjects will be excluded from PDL treatment if they have any contraindications to PDL a. exposure to Accutane® (isotretinoin) within 6 months of QWO (CCH-aaes) treatment.