CompletedPhase 4

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

United States48 participantsStarted 2020-12-28

Plain-language summary

This study will investigate treatments that may mitigate bruising after QWO™ (Collagenase clostridium histolyticum \[CCH\]-aaes) treatment of cellulite in the buttocks.

Who can participate

Age range18 Years – 50 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Have both buttocks with:
✓. Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) score of 3 (moderate) as reported by the Investigator, and
✓. Hexsel Cellulite Severity Scale (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).
✓. Have a body mass index between ≥18 and ≤30 kilograms (kg)/square meter (m\^2).
✓. Be willing to apply sunscreen before each exposure to the sun while participating in the study (that is, Baseline through end of study).
✓. Be judged to be in good health.
✓. Be willing and able to cooperate with the requirements of the study.

Exclusion criteria

✕. Has a coagulation disorder including but not limited to a Factor II, V, VII, or X deficiency.
✕. Has local conditions in the areas to be treated (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation.
✕. Has skin laxity or linear undulations on buttocks that can be effaced by lifting skin.
✕. Requires the following concomitant medications during the study and cannot discontinue these medications within the time specified before CCH-aaes treatment.
✕. Antiplatelet medication (clopidogrel \[Plavix®\] including aspirin at any dose within 14 days of treatment.
✕. Anticoagulants, such as warfarin (Coumadin®); heparin analogues within 14 days of treatment.
✕. Non-steroidal anti-inflammatory drugs (NSAIDS), such as ibuprofen (Motrin®, Advil®) and naproxen (Aleve®) 7 days before the study.
✕. Any medications or food that have or have been reported to have anticoagulant effects within 14 days of treatment.

What they're measuring

Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4

Timeframe: Day 4 (3 days after CCH-aaes injection)

Trial details

NCT IDNCT04677712

SponsorEndo Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06-26

Results submitted2022-08-22

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