CompletedPhase 2

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

United States91 participantsStarted 2022-06-15

Plain-language 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 \[CCH-aaes\]).

Who can participate

Age range18 Years – 60 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.

Exclusion criteria

✕. history of venous or arterial thromboembolism or current thromboembolic disease.
✕. history of or current renal impairment.
✕. serum creatinine concentration \> 1.4 milligram/deciliter at Screening.
✕. concurrently taking combination hormonal contraceptives.
✕. concurrently undergoing hormone replacement therapy.
✕. is a current smoker of nicotine or cannabinoids.

What they're measuring

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)

Trial details

NCT IDNCT05419505

SponsorEndo Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-01-03

Results submitted2024-01-02

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